2015 OS - Fanelli Surgery Powerpoint

7/24/2019 2015 OS - Fanelli Surgery Powerpoint

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Rationale and Surgical Technique for PCL and

Multiple Knee Ligament Reconstruction

Featuring the FanelliPCL/ACL System,

Bio-CoreInterference Screw, Poly Suture Button,

FanelliMagellan Suture Retriever and Graft Tensioning Boot

Gregory C. Fanelli, M.D.


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Facilitates PCL andACL reconstructiontechniques

FanelliSystemInstruments

Graft Tensioning

Boot Self retaining tensioner

eliminates manualtensioning

Allows surgeon touse both handsfor tibial fixation

Tension grafts upto 20 lbs

Double Bundle

Aimers Size specific aimers

for double bundletunnel diameters

Allows visualizationof tunnel placementin double bundle PCLand ACL proceduresto provide adequatebone bridge

The FanelliPCL/ACL Guide

facilitates accurate and

reproducible tunnel placement for

PCL and ACL Reconstructions.

FanelliMagellan

Suture Retriever Facilitates suture

retrieval during PCL andACL reconstruction

Promotes reproduciblegraft passage


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OverviewThis manual contains the surgical technique

for the transtibial tunnel posterior cruciateligament (PCL) reconstruction, combined

anterior cruciate ligament (ACL) and

posterior cruciate ligament reconstruction

using the ArthrotekFanelliPCL/ACL

System, and several methods of medial and

lateral side reconstructions. The reference

section contains a list of text books, and

scientific articles on these subjects, and the

reader is referred to these resources for a

more in depth review of the subject material.

Patient PositioningThe patient is placed on the operating

room table in the supine position, and

after satisfactory induction of anesthesia,

the operative and nonoperative lower

extremities are carefully examined. A

tourniquet is applied to the upper thigh of

the operative extremity, and that extremity is

prepped and draped in a sterile fashion.

When allograft tissue is used, it is prepared

prior to bringing the patient into theoperating room. Autograft tissue is

harvested prior to beginning the

arthroscopic portion of the procedure.

The arthroscopic instruments are inserted

with the inflow through the superolateral

patellar portal. Instrumentation and

visualization is achieved through

inferomedial and inferolateral patellar

portals, and can be interchanged as

necessary. Additional portals are established

as necessary. Exploration of the joint consists

of evaluation of the patellofemoral joint,

the medial and lateral compartments,

medial and lateral menisci, and the

intercondylar notch.

When there is a posterior cruciate ligament

tear, the tear of the PCL is identified and the

intact anterior cruciate ligament is confirmed.

The residual stump of the posterior cruciate

ligament is debrided with the synovial

shaver and hand tools as necessary. In the

case of a combined ACL/PCL injury, the

residual stumps of both the anterior and

posterior cruciate ligaments are debrided.

In patients with combined ACL/PCL injuries,

the notchplasty for the ACL portion of the

procedure is performed at this time.

Rationale and Surgical Technique for PCL

and Multiple Knee Ligament Reconstruction

Poly Suture Button

Solid fixation for eitherprimary or auxiliaryfixation in ACL or PCLreconstruction

Distal fixation allowscircumferential healingof the ACL and/or PCLgraft to the tunnel wall

Bio-CoreInterference Screw

Resorbable interferencescrew made ofLactoSorbL15resorbable copolymer

Ability to be filledwith autograft orallograft bone

This brochure is presented to demonstrate the surgical technique utilized

by Gregory Fanelli, M.D. Arthrotek, as the manufacturer of this device, does

not practice medicine and does not recommend this or any other surgical

technique for use on a specific patient. The surgeon who performs any

procedure is responsible for determining and utilizing the appropriate

techniques for such procedure for each individual patient. Arthrotek is not

responsible for selection of the appropriate surgical technique to be utilized

for an individual patient.

Rehabilitation activities vary depending on the individual patient and

physicians recommendations.

The FanelliPCL/ACL System was developed in conjunction with Gregory C.

Fanelli, M.D., Danville, Pennsylvania.

Bio-Coreand Fanelliare trademarks of Arthrotek, Inc.

LactoSorbis a trademark of Biomet Manufacturing Corp.


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Surgical Technique

Figure 1

Figure 3

Initial Incision

An extra capsular extraarticular posteromedial safetyincision is made by creating an incision approximately

1.5 to 2cm long starting at the posteromedial border of

the tibia approximately one inch below the level of the

joint line and extending distally (Figure 1). Dissection

is carried down to the crural fascia, which is incised

longitudinally. Care is taken to protect the neurovascular

structures. An interval is developed between the medial

head of the gastrocnemius muscle posterior, and the

capsule of the knee joint anterior. The surgeons gloved

finger is able to position the neurovascular structures

posterior to the finger and the capsule anterior tothe finger (Figure 2). This is so that the surgeon can

monitor tools such as the over-the-top PCL tools, and

the Fanelli PCL/ACL drill guide as it is positioned in

the posterior aspect of the knee. This also allows for

accurate placement of the guide wire both in a medial

lateral, and a proximal distal direction. The PCL and

ACL reconstructions are performed with the knee in

approximately 70 90of knee flexion.

Elevating the Capsule

The curved over-the-top PCL instruments are used tosequentially lyse adhesions in the posterior aspect of

the knee, and elevate the capsule from the tibial ridge

posterior. This will allow accurate placement of the

FanelliPCL/ACL guide, and correct placement of the

tibial tunnel (Figure 3).

Figure 2


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Positioning of the Guide

The arm of the FanelliPCL/ACL guide is insertedthrough the inferior medial patellar portal. The tip of the

guide is positioned at the inferior lateral aspect of the

PCL anatomic insertion site. This is below the tibial ridge

posterior and in the lateral aspect of the PCL anatomic

insertion site. The bullet portion of the guide contacts

the anteromedial surface of the proximal tibia at a point

midway between the posteromedial border of the tibia,

and the tibial crest anterior approximately 1cm below

the tibial tubercle (Figure 4). This will provide an angle of

graft orientation such that the graft will turn two very

smooth 45 angles on the posterior aspect of the tibiaand will not have an acute 90 angle turn which may

cause pressure necrosis of the graft (Figure 5).

The tip of the guide, in the posterior aspect of the tibia, isconfirmed with the surgeons finger through the

extracapsular extraarticular posteromedial safety

incision. Intraoperative AP and lateral X-ray may also be

used. The FanelliPCL/ACL guide may be adjusted so

that the guide wire shoots to the tip or the elbow of the

guide as the surgeon prefers. When the FanelliPCL/ACL

guide is positioned in the desired area, a blunt spade-

tipped guide wire (909634) is drilled from anterior to

posterior. The arthroscope, in the posterior medial portal,

visualizes the tip of the guide wire. The surgeons finger

confirms the position of the guide wire through theposterior medial safety incision. This is a double

safety check.

Figure 4

Figure 5


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Surgical Technique

Figure 7

Figure 6

Drilling the Tibial Tunnel

The appropriately sized standard cannulated reamer isused to create the tibial tunnel. The curved PCL closed

curette is positioned to cup the tip of the guide wire.

The arthroscope, positioned in the posterior medial

portal, visualizes the guide wire being cupped, which

protects the neurovascular structures (Figure 6). The

surgeons finger through the extra capsular extraarticular

posteromedial incision is monitoring the position of

the guide wire. When the drill is engaged in bone, the

guide wire is reversed, blunt end pointing posterior, for

additional patient safety.

The drill is advanced until it comes to the posterior cortexof the tibia. The chuck is disengaged from the drill, and

completion of the tibial tunnel is performed by hand

(Figure 7). This gives an additional margin of safety for

completion of the tibial tunnel. The tunnel edges are then

chamfered and rasped with the FanelliPCL/ACL system

rasp (Figure 8).

Figure 8


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Figure 9

Figure 10

Drilling the Femoral Tunnel Outside In:

Single and Double Bundle PCL ReconstructionThe FanelliPCL/ACL guide is positioned to create the

femoral tunnel. The arm of the guide is introduced

through the inferomedial patellar portal and is

positioned such that the guide wire will exit through the

center of the stump of the anterior lateral bundle of the

posterior cruciate ligament (Figure 9).

The blunt spade-tipped guide wire (909634) is drilled

through the guide, and just as it begins to emerge

through the center of the stump of the PCL anterior

lateral bundle, the drill guide is disengaged. The

accuracy of the placement of the wire is confirmed

arthroscopically with probing and visualization. Care

must be taken to ensure the patellofemoral joint has

not been violated by arthroscopically examining the

patellofemoral joint prior to drilling.

The appropriately sized standard cannulated reamer is

used to create the femoral tunnel. A curette is used to

cap the tip of the guide wire so there is no inadvertent

advancement of the guide wire, which may damage

the anterior cruciate ligament or articular surface. As

the reamer is about to penetrate interiorly, the reamer

is disengaged from the drill and the final reaming is

completed by hand (Figure 10). This adds an additional

margin of safety. The reaming debris is evacuated with

a synovial shaver to minimize fat pad inflammatory

response with subsequent risk of arthrofibrosis. Thetunnel edges are chamfered and rasped.


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Surgical Technique

Figure 12

Figure 11

Drilling the Femoral Tunnel Outside In:

Single and Double Bundle PCL Reconstruction (continued)When the double bundle PCL reconstruction is

performed, the FanelliPCL/ACL guide is positioned

to create the second femoral tunnel. The arm of the

guide is introduced through the inferior medial patellar

portal, and is positioned such that the guide wire will

exit through the center of the stump of the posterior

medial bundle of the posterior cruciate ligament

(Figure 11). The blunt spade-tipped guide wire (909634)

is drilled through the guide, and just as it begins to

emerge through the center of the stump of the PCL

posterior medial bundle, the drill guide is disengaged.The accuracy of the placement of the wire is confirmed

arthroscopically with probing and visualization. Care

must be taken to ensure that there will be an adequate

bone bridge (approximately 5mm) between the two

femoral tunnels prior to drilling. This is accomplished

using the calibrated probe, and direct arthroscopic

visualization.

The appropriately sized standard cannulated reamer

is used to create the posterior medial bundle femoral

tunnel. A curette is used to cap the tip of the guide wire

so there is no inadvertent advancement of the guide

wire, which may damage the anterior cruciate ligament,

or articular surface. As the reamer is about to penetrate

interiorly, the reamer is disengaged from the drill and

the final reaming is completed by hand (Figure 12).

This adds an additional margin of safety. The reaming

debris is evacuated with a synovial shaver to minimize

fat pad inflammatory response with subsequent riskof arthrofibrosis. The tunnel edges are chamfered and

rasped.


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Figure 13 Figure 14

Drilling the Femoral Tunnel Inside Out:

Single and Double Bundle PCL ReconstructionThe PCL single bundle or double bundle femoral

tunnels can be made from inside out using the Fanelli

Double Bundle Aimers. The appropriately sized double

bundle aimer is inserted through a low anterior lateral

patellar arthroscopic portal. The double bundle aimer

is positioned directly on the footprint of the femoral

anterior lateral bundle PCL insertion site (Figure 13). The

appropriately sized guide wire is drilled through the

aimer, through the bone, and out a small skin incision.

Care is taken to insure there is no compromise of the

articular surface.

The double bundle aimer is removed, and an acorn

reamer is used to endoscopically drill from inside out the

anterior lateral bundle PCL femoral tunnel (Figure 14).

The tunnel edges are chamfered and rasped. The

reaming debris is evacuated with a synovial shaver to

minimize fat pad inflammatory response with

subsequent risk of arthrofibrosis. When the surgeon

chooses to perform a double bundle double femoral

tunnel PCL reconstruction, the same process is repeated

for the posterior medial bundle of the PCL (Figures 15

and 16). Care must be taken to ensure that there will bean adequate bone bridge (approximately 5mm)

between the two femoral tunnels prior to drilling. This is

accomplished using the calibrated probe, and direct

arthroscopic visualization.

Figure 16

Figure 15


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Surgical Technique

Figure 18

Figure 17

Figure 20

Tunnel Preparation, Graft Passage,

and PCL Femoral FixationA FanelliMagellan suture retriever (909808) is

introduced through the tibial tunnel into the joint

(Figure 17), and may be retrieved through the femoral

tunnel (Figure 18). The traction sutures of the graft

material are attached to the loop of the Magellan

suture retriever, and the graft is pulled into position.

The graft material is secured on the femoral side using

the ArthrotekBio-CoreInterference Screw for primary

aperture opening fixation, and an ArthrotekPoly Suture

Button for back up fixation.

PCL Graft Tensioning and

Tibial FixationTension is placed on the PCL graft

distally using the ArthrotekGraft

Tensioning Boot, and the tension

is set to restore the anatomic

tibial step off. The knee is cycled

through a full range of motion

25 times to allow pre-tensioning

and settling of the graft. In double

bundle PCL reconstructions, each

bundle is individually tensioned.

The process is repeated untilthere is no further change in

the torque setting on the graft

tensioner and the anatomic tibial

step off is restored. The knee is

placed in 70 of flexion, and fixation is achieved on the

tibial side of the PCL graft with an ArthrotekBio-Core

Interference Screw, and back up fixation with a bicortical

screw and spiked ligament washer (Figure 20).

Figure 19


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Figure 22

Figure 21

ACL Reconstruction

With the knee in approximately 70 90 of flexion, theACL tunnels are created using the FanelliPCL/ACL

guide. The arm of the FanelliPCL/ACL guide enters the

knee joint through the inferior medial patellar portal

(Figure 21). The bullet of the drill guide contacts the

anterior medial proximal tibia externally at a point

approximately 1 cm proximal to the tibial tubercle

midway between the posterior medial border of the

tibia, and the tibial crest anteriorly. The guide wire is

drilled through the guide to emerge through the center

of the stump of the ACL tibial footprint. A standard

cannulated reamer is used to create the tibial tunnel(Figure 22). Reaming debris is evacuated, and the tunnel

edges are chamfered and rasped.


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Surgical Technique

Figure 24

ACL Reconstruction (continued)

With the knee in approximately 90 of flexion, an overthe top Femoral Aimer is introduced through the tibial

tunnel, and used to position a guide wire on the medial

wall of the lateral femoral condyle (Figure 23). The

femoral tunnel is created to approximate the ACL

anatomic insertion site, and the off set of the size specific

Femoral Aimer will leave a 12mm posterior cortical

wall so interference fixation can be used (Figure 24).

The ACL graft is positioned, and fixation achieved on the

femoral side using an ArthrotekBio-CoreInterference

Screw, and back up fixation with an ArthrotekPoly

Suture Button.

The ACL graft is tensioned on the tibial side using theArthrotekGraft Tensioning Boot (Figure 25). Traction is

placed on the ACL graft sutures, and tension is set. The

knee is then cycled through 25 full flexion and extension

cycles to allow settling of the graft. The process is

repeated until there is no further change in the torque

setting on the graft tensioner. The knee is placed

in 70 of flexion, and fixation is achieved on

the tibial side of the ACL graft with an Arthrotek

Bio-CoreInterference Screw, and back up fixation with

an ArthrotekPoly Suture Button. The final ACL and PCL

tunnel positions are demonstrated in Figures 26 and 27.

Figure 23


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Figure 25

Figure 26

Figure 27


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Surgical Technique

Figure 28

Lateral Posterolateral Reconstruction

Posterolateral reconstruction with the free graft figureof eight technique utilizes semitendinosus autograft or

allograft, Achilles tendon allograft, or other soft tissue

allograft material (Figure 28). A curvilinear incision is

made in the lateral aspect of the knee extending from

the lateral femoral epicondyle to the interval between

Gerdys tubercle and the fibular head. The peroneal

nerve is dissected free, and protected throughout the

procedure. The fibular head is exposed and a tunnel

is created in an anterior to posterior direction at the

area of maximal fibular diameter. The tunnel is created

by passing a guide pin followed by a cannulated drillusually 7mm in diameter. The free tendon graft is passed

through the fibular head drill hole. An incision is then

made in the iliotibial band in line with the fibers directly

overlying the lateral femoral epicondyle.

One surgical technique for posterolateral reconstructionis the free graft figure of eight technique utilizing

semitendinosus autograft or allograft, Achilles tendon

allograft, or other soft tissue allograft material

(Figure 28). This procedure requires an intact proximal

tibiofibular joint. This technique combined with capsular

repair and/or posterolateral capsular shift procedures,

mimics the function of the popliteofibular ligament and

lateral collateral ligament, tightens the posterolateral

capsule, and provides a post of strong allograft tissue

to reinforce the posterolateral corner. When there is a

disrupted proximal tibiofibular joint, or hyperextensionexternal rotation recurvatum deformity, a two-

tailed (fibular head, proximal tibia) posterior lateral

reconstruction may be required (Figure 29).

Figure 29


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The graft material is passed medial to the iliotibialband, and the limbs of the graft are crossed to form

a figure of eight. A drill hole is made approximately

1cm anterior to the fibular collateral ligament and

popliteus tendon femoral insertion. A longitudinal

incision is made in the lateral capsule just posterior

to the fibular collateral ligament. The graft material is

passed medial to the iliotibial band and secured to the

lateral femoral epicondylar region with a screw and

spiked ligament washer at the above mentioned point.

The posterolateral capsule that had been previously

incised is then shifted and sewn into the strut of figureof eight graft tissue material to eliminate posterolateral

capsular redundancy. The anterior and posterior limbs of

the figure of eight graft material are sewn to each other

to reinforce and tighten the construct. The final graft

tensioning position is approximately 30 40 of knee

flexion. The iliotibial band incision is closed.


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Surgical Technique

Figure 31

Figure 30

Medial Posteromedial Reconstruction

When superficial MCL reconstruction is indicated, this isperformed using allograft or autograft tissue (Figure 31).

This graft material is attached at the anatomic insertion

sites of the superficial medial collateral ligament on

the femur and tibia using a screw and spiked ligament

washer, or suture anchors. The posteromedial capsular

advancement is performed, and sewn into the newly

reconstructed MCL. The final graft tensioning position is

approximately 30 40 of knee flexion.

Posteromedial and medial reconstructions areperformed through a medial incision. Care is taken to

maintain adequate skin bridges between incisions, and

to protect the neurovascular structures. The superficial

medial collateral ligament is exposed, and a longitudinal

incision is made just posterior to the posterior border of

the superficial MCL (Figure 30).

Care is taken to protect the medial meniscus during

the capsular incision. The interval between the

posteromedial capsule and medial meniscus is

developed. The posteromedial capsule is shifted

anterosuperiorly. The medial meniscus is repaired to thenew capsular position, and the shifted capsule is sewn

into the medial collateral ligament.


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Overview of Graft Tensioning

and FixationThe PCL is reconstructed first followed by the ACL

followed by the posterolateral complex, and medial

ligament complex. Tension is placed on the PCL graft

distally using the ArthrotekGraft Tensioning Boot.

This restores the anatomic tibial step off. The knee is

cycled through a full range of motion 25 times to allow

pretensioning and settling of the graft. The knee is

placed in 70 of flexion, and fixation is achieved on the

tibial side of the PCL graft with an ArthrotekBio-Core

Interference Screw, and screw and spiked ligament

washer. The ArthrotekGraft Tensioning Boot is applied

to the ACL graft.

The knee is placed in 70 of flexion, and final fixation is

achieved of the ACL graft with a ArthrotekBio-Core

Interference Screw, and ArthrotekPoly Suture Button

back-up fixation on the femoral and tibial sides.

Tensioning the ACL graft at 70 of knee flexion enabled

us to maintain the neutral position of the knee by

monitoring the tibial step off at the time of final graft

fixation. The knee is placed in 30 of flexion, slight valgus

force applied to the knee, and final tensioning and

fixation of the posterolateral corner is achieved. The MCL

reconstruction is tensioned with the knee in 30 offlexion. Full range of motion is confirmed on the

operating table to assure the knee is not captured by

the reconstruction.

Additional Technical IdeasThe posteromedial safety incision protects the

neurovascular structures and confirms accurate tibialtunnel placement. It is important to be aware of the two

tibial tunnel directions, and to have an adequate bone

bridge between the PCL and ACL tibial tunnels. This will

reduce the possibility of fracture. We have found it useful

to use primary and back-up fixation. Primary fixation

is with ArthrotekBio-CoreInterference Screws, and

back-up fixation is performed with a screw and spiked

ligament washer, an ArthrotekPoly Suture Button.

Secure fixation is critical to the success of this surgical

procedure. Restoration of the normal tibial step-off

at 70 of flexion has provided the most reproduciblemethod of establishing the neutral point of the tibia-

femoral relationship in our experience. Full range of

motion is confirmed on the operating table to assure the

knee is not captured by the reconstruction.

The Fanelli Sports Injury Clinic results for our PCL and

multiple ligament knee reconstructions are detailed

in the references listed in this technique manual. The

reader is referred to these resources.


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References

PCL and Multiple Knee Ligament Injury Text Books by Gregory C. Fanelli, M.D.

Posterior Cruciate Ligament Injuries: A Practical Guide To Management. Editor: Gregory C. Fanelli, M.D., Springer-Verlag,

New York, 2001.

The Multiple Ligament Injured Knee. A Practical Guide to Management. Editor: Gregory C. Fanelli, M.D., Springer-Verlag,

New York, 2004.

PCL and Multiple Knee Ligament Injury Related Peer Reviewed Articles by Gregory C. Fanelli, M.D.

Gregory C. Fanelli, M.D., Posterior Cruciate Ligament Injuries In Trauma Patients. Arthroscopy9(3) pp. 291294, 1993.

Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig Edson, P.T.: Current Concepts Review. The Posterior Cruciate Ligament:Arthroscopic Evaluation And Treatment.Arthroscopy Vol. 10, No. 6. pp. 673688, December, 1994.

Gregory C. Fanelli, M.D., Craig J. Edson, P.T./A.T.C.: Posterior Cruciate Ligament Injuries In Trauma Patients: Part II.ArthroscopyVol.

11, No. 5. pp. 526529, 1995.

Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig J. Edson, M.S., P.T., A.T.C.: Arthroscopically Assisted Combined ACL/PCLReconstruction. Arthroscopy, Vol. 12, No.1., pp. 514, 1996.

Gregory C. Fanelli, M.D., Bradley Giannotti, M.D., Craig J. Edson, M.S., P.T., A.T.C.: Arthroscopically Assisted PCL/Posterior LateralComplex Reconstruction.Arthroscopy, Vol. 12, No. 5, 1996.

Raymond M. Bleday, M.D., Gregory C. Fanelli, M.D., Bradley F. Giannotti, M.D., Craig J. Edson, M.H.S., P.T., A.T.C., Thomas A Barrett,M.D.: Instrumented Measurement of the Posterolateral Corner. Arthroscopy, Vol. 14, No. 5: 489494, 1998.

Gregory C. Fanelli, M.D., Daniel D. Feldmann, M.D., The Dislocated/Multiple Ligament Injured Knee. Operative Techniques InOrthopaedics, 9(4):112, 1999.

Gregory C. Fanelli, M.D., Daniel D Feldmann, M.D., Management of Combined Anterior Cruciate Ligament/Posterior CruciateLigament/Posterolateral Complex Injuries of the Knee. Operative Techniques In Sports Medicine, 7(3):143149, 1999.

Gregory C. Fanelli, M.D.: Combined Anterior and Posterior Cruciate Ligament Injuries: The Multiple Ligament Injured Knee.Sports Medicine And Arthroscopy Review, 7(4):289295, 1999.

Gregory C. Fanelli, M.D., Timothy J. Monahan, M.D.: Complications of Posterior Cruciate Ligament Reconstruction. Sports MedicineAnd Arthroscopy Review,7(4):296302, 1999.

Gregory C. Fanelli, M.D.: Treatment of Combined Anterior Cruciate Ligament-Posterior Cruciate Ligament-Lateral Side Injuries ofthe Knee. Clinics In Sports Medicine,19(3):493502, 2000.

Gregor y C. Fanelli, M.D., Craig J. Edson, M.S., P.T./A.T.C., David R. Maish, M.D.: Management of Combined ACL/PCL injuries.Techniques In Orthopaedics,16(2):157166, 2001.

Gregory C. Fanelli, M.D., Timothy J. Monahan, M.D.: Complications in posterior cruciate ligament and posterolateral complexsurgery. Operative Techniques In Sports Medicine. April, 9(2);9699, 2001.

Gregory C. Fanelli, M.D.: Surgical Treatment of the Acute and Chronic ACL/PCL/Medial Side/Lateral Side Injuries of the Knee.Sports Medicine and Arthroscopy Review,September, 9(3), 2001.

Gregory C. Fanelli, M.D., Roger V. Larson, M.D.: Practical Management of Posterolateral Instability of the Knee. Arthroscopy,18(2){February, Suppl 1}:18, 2002.

Gregory C. Fanelli, M.D., Craig J. Edson, M.S., P.T./A.T.C.: Arthroscopically Assisted Combined ACL/PCL Reconstruction. 210 yearFollow-up.Arthroscopy,18(7):703-714, 2002.


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Gregory C. Fanelli, M.D.: Arthroscopic Posterior Cruciate Ligament Reconstruction: Transtibial Tunnel Technique. SurgicalTechnique and 210 Year Results.Arthroscopy,18(9):4449, (December Supplement 2), 2002.

Gregor y C. Fanelli, M.D.: Surgical Treatment of ACL-PCL-Medial Side-Lateral Side Injuries of the Knee. Operative Techniques inSports Medicine,11(4):263274, 2003.

Gregory C. Fanelli, M.D.: Systematic Approach to the Multiple Ligament Injured Knee. Arthroscopy; 19(3037): (DecemberSupplement 1), 2003.

Gregory C. Fanelli, M.D., Craig J Edson, M.S., P.T./A.T.C.: Combined Posterior Cruciate Ligament Posterolateral Reconstructionwith Achilles Tendon Allograft and Biceps Femoris Tendon Tenodesis: 210 year Follow-up.Arthroscopy, 20 (4): 339345, 2004.

Gregory C. Fanelli, M.D., Daniel R. Orcutt, M.D.: Complications in Posterior Cruciate Ligament Reconstruction. Sports Medicine andArthroscopy Review, 12 (3): 196201, 2004.

Bergfeld JA, Cooper DE, Fanelli GC, Harner CD: Round Table Discussion. Reconstructing the PCL: Tips and Techniques.Orthopaedics Today, 24 (12): 1,1621, 2004.

Gregory C. Fanelli, M.D., Daniel R. Orcutt, M.D., Craig J. Edson, M.S., P.T., A.T.C.: Current Concepts: The Multiple Ligament InjuredKnee.Arthroscopy, 21 (4): 471486, 2005.

Gregory C. Fanelli, M.D.: Surgical Reconstruction for Acute Posterolateral Injury of the Knee. Journal of Knee Surgery, 18 (2):157162, 2005.

Fanelli GC, Edson CJ, Orcutt DR, Harris JD, Zijerdi D.: Treatment of Combined ACL-PCL-MCL-PLC Injuries of the Knee. Journal ofKnee Surgery,18 (3):240248, 2005.

Gregory C. Fanelli, M.D.: Surgical Treatment of Lateral Posterolateral Instability of the Knee Using Biceps Femoris TendonProcedures. Sports Medicine and Arthroscopy Review, February, 14(1), 2006.

Fanelli GC, Harris JD: Surgical Treatment of Acute Medial Collateral Ligament and Posteromedial Corner Injuries of the Knee.Sports Medicine and Arthroscopy Review, May, 14(2), 2006.

Fanelli GC, Harris JD. : Late MCL (Medial Collateral Ligament) Reconstruction. Techniques In Knee Surgery, (In Press), 2006.


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Package Inserts

The information contained in this packa ge insert was current on the date this brochure was printed. However, the package insert may have been revised after that

date. To obtain a current package insert, please use the contact information provided herein.

Arthrotek, Inc. 01-50-1058A Wholly Owned Subsidiary of Biomet, Inc. Date: 07/0456 East Bell DriveP.O. Box 587

Warsaw, Indiana 46581 USA

RESORBABLE INTERFERENCE SCREW

ATTENTION OPERATING SURGEON

DESCRIPTIONArthrotek Resorbable Interference Screw is a resorbable interference fixation screw. Thedevice is made of LactoSorb, a resorbable copolymer, which is a polyester derivative of lacticacid and glycolic acid. Polylactic/ polyglycolic acid copolymer degrades and resorbsin vivobyhydrolysis to lactic and glycolic acids that are then metabolized by the bo dy.

INDICATIONSIndications for use: Indications for the Resorbable Interference Screw include use in soft tissuereattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specificindications include the following:

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotatorcuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis,deltoid repair.Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateralligament reconstruction.Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/

reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction,biceps tendon reconstruction.Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateralcollateral ligament (LCL) repair, posterior oblique ligament repair, joint capsuleclosure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair,and vastus medialis obliquus (VMO) muscle advancement.

In addition to the above indications, 7.0mm, 8.0mm, 9.0mm, 10.0mm, 11.0mm, and 12.0mmscrews are indicated for the following uses: 1. To provide interference fixation of patellar bone-tendonbone grafts in anterior

cruciate ligament (ACL) reconstruction. 2. To provide interference fixation during femoral and/or tibial fixation in anterior

cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis). 3. To provide interference fixation during posterior cruciate ligament (PCL)

reconstruction.

CONTRAINDICATIONS 1. Active infection. 2. Patients with mental or neurologic conditions who are unwilling or incapable of

following postoperative care instructions. 3. Patient conditions including: blood supply limitations, insufficient quantity or quality

of bone for attachment or latent infections.

4. Pathologic soft tissue conditions, which would prevent secure fixations.

WARNINGSArthrotek internal fixation devices provide the surgeon with a means to aid in the managementof soft tissue to bone reattachment procedures. While these devices are generally successfulin attaining these goals, they cannot be expected to replace normal healthy soft tissueor withstand the stress placed upon the device by full or partial weight bearing or loadbearing, particularly in the presence of incomplete healing. Therefore, it is important thatimmobilization (use of external support, sling, etc.) of the treatment site be maintaineduntil healing has occurred. Surgical implants are subject to repeated stresses in use, whichcan result in fracture or damage to the implant. Factors such as the patients activity leveland adherence to weight bearing or load bearing instructions have an affect on the servicelife of the implant. The surgeon must be thoroughly knowledgeable not only in the medicaland surgical aspects of the implant, but also must be aware of the mechanical and polymericaspects of the surgical implants.

1. Correct selection of the implant is extremely important. The potential for successin soft tissue to bone fixation is increased by the selection of the proper typeof implant. While proper selection can help minimize risks, the device is not designedto withstand the unsupported stress of full weight bearing, load bearing or excessiveactivity.

2. The implants can loosen or be damaged when subjected to increased loading

associated with inadequate healing. If heali ng is delayed, or does not occur, theimplant or the procedure may fail. Loads produced by weight bearing and activitylevels may dictate the longevity of the implant.

3. Inadequate fixation at the time of surgery can increase the risk of loosening andmigration of the device or tissue supported by the device. Sufficient bone quantityand quality are important to adequate fixation and success of the procedure. Bonequality must be assessed at the time of surgery. Adequate fixation in diseased bonemay be more difficult. Patients with poor quality bone, such as osteoporotic bone, areat greater risk of device loosening a nd procedure failure.

4. Care is to be taken to assure adequate soft tissue fixation at the time of surgery.Failure to achieve adequate fixation through improper positioning or placement ofthe device can contribute to a subsequent undesirable result.

5. The use of appropriate immobilization and postoperative management is indicated

as part of the treatment until healing has occurred. 6. Correct handling of implants is extremely important. Do not modify implants. Do

not notch or bend implants. Notches or scratches put in the implant during thecourse of surgery may contribute to breakage. Intraoperative fracture of screws canoccur if excessive force (torque) is applied while seating bone screws.

7. Do not heat LactoSorbInterference Screws by any means prior to implantation. 8. DO NOT USE if there is loss of sterility of the device. Discard and DO NOT USE opened

or damaged devices, and use only devices that are p ackaged in unopened andundamaged containers.

9. DO NOT USE where a permanent implant is indicated.10. DO NOT USE with other resorbable implant materials. 11. Adequately instruct the patient. Postoperative care is important. The patients ability

and willingness to follow instructions is one of the most important aspects ofsuccessful soft tissue ma nagement. Patients affected with senility, mental illness,alcoholism, and drug abuse may be at a higher risk of device or procedure failure. Thesepatients may ignore instructions and activity restrictions. The patient is to be instructedin the use of external supports that are intended to immobilize the repair site and limitweight bearing or load bearing. The patient is to be made fully aware and warned thatthe device does not replace normal healthy tissue, and that the device can break, bendor be damaged as a result of stress, activity, load bearing, or weight bearing. The patientis to be made aware and warned of general surgical risks, possible adverse effects, andto follow the instructions of the treating physician. The patient is to be advised of theneed for regular postoperative follow-up examination as long as the device remainsimplanted.

PRECAUTIONSInstruments are available to aid in the accurate implantation of internal fixation devices.Intraoperative fracture or breaking of instruments has been reported. Surgical instrumentsare subject to wear with normal usage. Instruments, which have experienced extensive useor excessive force, are susceptible to fracture. Surgical instruments should only be used fortheir intended purpose. Arthrotek recommends that all instruments be regularly inspectedfor wear and disfigurement.

POSSIBLE ADVERSE EFFECTS 1. Infection can lead to failure of the procedure. 2. Neurovascular injuries can occur due to surgical trauma. 3. Bending, fracture, loosening, rubbing, and migration of the implant may occur as a

result of excessive activity, trauma, or load bearing. 4. Implantation of foreign materials can result in an inflammatory response or allergic

reaction. 5. Inadequate healing which may lead to breakage of the implant or failure of the graft

material. 6. Pain, discomfort, or abnormal sensation due to the presence of the device. 7. Necrosis of the bone or tissue.

STERILITYArthrotek resorbable implants are sterilized by exposure to Ethylene Oxide (ETO) Gas. Do notresterilize. Do not use past expiration date.

STORE AT OR BELOW ROOM TEMPERATURE. DO NOT EXPOSE PRODUCT TO TEMPERATURESGREATER THAN 120F OR 49C.

Caution: Federal Law (USA) restricts this device to sale, distribution, or use by or on the orderof a physician.

Comments regarding this device can be directed to Attn: Regulatory Dept., Biomet, Inc.,P.O. Box 587, Warsaw, IN 46581 USA, Fax: 574-372-1683.

Manufacturer: Authorized Representative:Biomet Manufacturing Corp. Biomet U.K., LtdAirport Industrial Park Waterton Industrial EstatesP.O. Box 587 Bridgend, South WalesWarsaw, IN 46581-058 7 CF31 3XA, U.K.

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Arthrotek, Inc. 01-50-10 18A Wholly Owned Subsidiary of Biomet, Inc. Date: 09/05P.O. Box 5 8756 East Bell Drive

Warsaw, Indiana 46581 USA

Arthrotek Internal Fixation DevicesAttention Operating Surgeon

DESCRIPTIONArthrotek manufactures a variety of internal fixation devices i ntended to aid in arthroscopicand orthopedic reconstructive procedures requiring soft tissue fixation, due to injury ordegenerative disease. Implants used for this a pplication include: screws, washers, anchors, pins,and suture. Specialty implants are available for specialized treatments.

Materials:316 LVM Stainless SteelTitanium AlloyUltra-High Molecular Weight Polyethylene (UHMWPE)Polyester

INDICATIONSThe Metal Screw Anchor and the Harpoon Suture Anchor are indicated for use in soft tissuereattachment procedures in the shoulder, wrist, elbow, and knee. Specific indications as follows:

Shoulder Indications Bankar t repair, SLAP lesion repair, acromio-clavicular separation,rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoidrepair.Wrist/Hand Indications Scapholunate ligament reconstruction, ulnar/radial collateralligament reconstruction.Ankle/Foot Indications Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.Elbow Indications Ulnar or radial collateral ligament reconstruction, biceps tendonreconstruction.Knee Indications Medial col lateral ligament repair, lateral collateral ligament repair,posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis, andpatellar ligament/tendon repair.

Bone Mulch Screws are intended for use in fixation of semitendinous and/or gracile tendongrafts in ACL reconstruction, only.

Interference Screws and Set Screws are intended for use in fixation of patell ar bone-tendon-bone grafts in ACL reconstruction.

Screw and Washers are indicated for soft tissue fixation to bone, and bone to bone fixation inorthopedic procedures specifically during Ligament reconstruction.

Toggle anchors (ie. toggle buttons and EZLoc) are indicated for use for fixation of tendonsand ligaments during orthopedic reconstruction procedures such as Anterior Cruciate

Ligament (ACL) Reconstruction.

Patient selection factors to be considered include: 1) need for soft tissue to bone fixation, 2)ability and willingness of the patient to follow postoperative care instructions until healing iscomplete, and 3) a good nutritional state of the patient.

CONTRAINDICATIONS1. Infection.

2. Patient conditions including blood supply limitations, and insufficient quantity orquality of bone or soft tissue.

3. Patients with mental or neurologic conditions who are unwilling or incapable offollowing postoperative care instructions.

4. Foreign body sensitivity. Where material sensitivity is suspected, testing is to becompleted prior to implantation of the device.

WARNINGSArthrotek internal fixation devices provide the surgeon with a means to aid in themanagement of soft tissue to bone reattachment procedures. While these devices are generallysuccessful in attaining these goals, they cannot be expected to replace normal healthy bone orwithstand the stress placed upon the device by full or partial weight bearing or load bearing,particularly in the presence of nonunion, delayed union, or incomplete healing. Therefore,it is important that immobili zation (use of external support, walking aids, braces, etc.) ofthe treatment site be maintained until healing has occurred. Surgical implants are subjectto repeated stresses in use, which can result in fracture or damage to the implant. Factorssuch as the patients weight, activity level, and adherence to weight bearing or load bearinginstructions have an effect on the service li fe of the implant. The surgeon must be thoroughlyknowledgeable not only in the medical and surgical aspects of the implant, but also must beaware of the mechanical and metallurgical aspects of the surgical implants.

1. Correct selection of the implant is extremely important. The potential for success insoft tissue to bone fixation is i ncreased by the selection of the proper type of implant.While proper selection can help minimize risks, neither the device nor grafts, when usedare designed to withstand the unsupported stress of full weight bearing, load bearingor excessive activity.

2. The implants can loosen or be damaged and the graft can fail when subjected toincreased loading associated with nonunion or delayed union. If healing is delayed,or does not occur, the implant or the procedure may fail. Loads produced by weightbearing, and activity levels may dictate the lo ngevity of the implant.

3. Inadequate fixation at the time of surgery can increase the risk of loosening andmigration of the device or tissue supported by the device. Sufficient bone quantity andquality are important to adequate fixation and success of the procedure. Bone qualitymust be assessed at the time of surgery. Adequate fixation in diseased bone may

be more difficult. Patients with poor quality bone, such as osteoporotic bone, are atgreater risk of device loosening and procedure fail ure.

4. Implant materials are subject to corrosion. Implanting metals and alloys subjects themto constant changing environments of salts, acids, and alkal is that can cause corrosion.Putting dissimilar metals and alloys in contact with e ach other can accelerate thecorrosion process that may enhance fracture of implants. Every effort should be madeto use compatible metals and al loys when marrying them to a common goal, i.e., screwsand plates.

5. Correct handling of implants is extremely important. Do not modify implants. Do notnotch or bend implants. Notches or scratches put in the implant during the courseof surgery may contribute to breakage. Intraoperative fracture of screws can occur ifexcessive force (torque) is applied while seating bone screws.

6. Do not use excessive force when inserting suture anchors. Excessive force (long hardhammer blows) may cause fracture or bending of the device. When encountering hardcortical bone, predrill with a 3/32 or 1/8 inch drill prior to i nserting suture anchors.

7. Adequately instruct the patient. Postoperative care is important. The patients abilityand willingness to follow instructions is one of the most important aspects of successfulfracture management. Patients effected with senility, mental illness, alcoholism, anddrug abuse may be at a higher risk of device or procedure failure. These patients mayignore instructions and activity restrictions. The patient is to be instructed in the use ofexternal supports, walking aids, and braces that are intended to immobilize the fracturesite and limit weight bearing or load bearing. The patient is to be made fully aware andwarned that the device does not replace normal healthy bone, and that the device canbreak, bend or be damaged as a result of stress, activity, load bearing, or weight bearing.The patient is to be made aware and warned of general surgical risks, possible adverseeffects, and to follow the instructions of the treating physician. The patient is to beadvised of the need for regular postoperative follow-up examination as long as thedevice remains implanted.

PRECAUTIONSDo not reuse implants. While an implant may appear undamaged, previous stress may havecreated imperfections that would reduce the service life of the implant. Do not treat withimplants that have been even momentarily pla ced in a different patient.

Instruments are available to aid in the a ccurate implantation of internal fixation devices.Intraoperative fracture or breaking of instruments has been reported. Surgical instrumentsare subject to wear with normal usage. Instruments, which have experienced extensive use orexcessive force, are susceptible to fracture. Surgical instruments should only be used for theirintended purpose. Arthrotek recommends that all instruments be regularly inspected for wearand disfigurement.

If device contains MaxBraid suture, refer to manufacturer package insert forfurther information.

POSSIBLE ADVERSE EFFECTS 1. Nonunion or delayed union, which may lead to breakage of the implant. 2. Bending or fracture of the implant. 3. Loosening or migration of the implant. 4. Metal sensitivity, or allergic reaction to a foreign body. 5. Pain, discomfort, or abnormal sensation due to the presence of the device. 6. Nerve damage due to surgical trauma. 7. Necrosis of bone or tissue. 8. Inadequate healing. 9. Intraoperative or postoperative bone fracture and/or postoperative pain.

STERILITYArthrotek internal fixation implants are typically supplied sterile and are sterilized byexposure to a minimum dose of 25kGy o f gamma radiation or by Ethylene Oxide Gas (ETO) ifdevice contains MaxBraidPE suture. If supplied sterile, do not resterilize the implant.

If not supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use.Do not sterilize UHMWPE implants using steam autoclaving methods. Do not use implants afterexpiration date.

Pre-VacuumSteam (HI-VAC) -- wrapped or unwrappedTemperature 270-275 F (132-135C)Exposure Time 5 MinutesDrying Time 8 Minutes

Since Arthrotek is not familiar with indivi dual hospital handling methods, cleaning methodsand bioburden, Arthrotek cannot assume responsibility for sterility even though the guidelineis followed.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Authorized Representative: Biomet U.K., Ltd. Waterton Industrial Estates,

Bridgend, South WalesCF31 3XA, U. K.

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The information contained in this packa ge insert was current on the date this brochure was printed. However, the package insert may have been revised after thatdate. To obtain a current package insert, please use the contact information provided herein.


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Ordering Information

FanelliPCL/ACL Guide

909800 Body

909804 PCL Bullet

FanelliMagellan

909808

Calibrated Probe

909799

Tunnel Awl

909798

Curved Rasp

909791

Cupped Curette

909792

Cupped Curette (Over the Back)

909793

Open Curette

909794

Open Curette (Over the Back)

909795

PCL Capsule Rasp

909790

Hook Knife

909796

Graft Tensioning Boot

909525

FanelliDouble Bundle Aimer

909747 7mm

909748 8mm

909749 9mm

909750 10mm

909751 11mm

909752 12mm

Femoral Aimer

909627 7mm

909628 8mm

909629 9mm

909630 10mm

909631 11mm

909632 12mm

Bio-CoreInterference Screw

905635 7 x 20mm

905636 7 x 25mm905637 7 x 30mm

905638 8 x 20mm

905639 8 x 25mm

905640 8 x 30mm

905641 9 x 20mm

905642 9 x 25mm

905643 9 x 30mm

905644 10 x 20mm

905645 10 x 25mm

905646 10 x 30mm

Poly Suture Button

904215 15mm

904219 19mm

Resorbable No-Profile Screw

905401 6.5 x 25mm

905402 6.5 x 30mm

905403 6.5 x 35mm

905404 6.5 x 40mm

905405 6.5 x 45mm

905406 6.5 x 50mm

905407 6.5 x 55mm

Resorbable No-Profile Spiked Washer

905418 18mm

No-Profile Cancellous Screw

904530 6.5 x 30mm

904535 6.5 x 35mm 904540 6.5 x 40mm

904545 6.5 x 45mm

904550 6.5 x 50mm

904555 6.5 x 55mm

904560 6.5 x 60mm

904565 6.5 x 65mm

904570 6.5 x 70mm

No-Profile Cortical Screw (Self Tapping)

904630 6.5 x 30mm

904632 6.5 x 32mm

904634 6.5 x 34mm 904636 6.5 x 36mm

904638 6.5 x 38mm

904640 6.5 x 40mm

904642 6.5 x 42mm

904644 6.5 x 44mm

904646 6.5 x 46mm

904648 6.5 x 48mm

904650 6.5 x 50mm

904652 6.5 x 52mm

904654 6.5 x 54mm

904656 6.5 x 56mm

904658 6.5 x 58mm

904660 6.5 x 60mm

No-Profile Spiked Washer

904414 14mm

904418 18mm

904420 20mm

No-Profile Flat Washer

904428 18mm


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Femoral Aimer Handle

909623

Femoral Aimer Replacement Ring Nut909627-03

Cannulated Drill Bit

909911 7mm

909913 8mm

909915 9mm

909917 10mm

909919 11mm

909921 12mm

Graft Sizing Block

906820

Cannulated End Cutting Reamer

909617 7mm

909618 8mm

909619 9mm

909620 10mm

909621 11mm

909622 12mm


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P.O. Box 587, Warsaw, IN 46581-0587 800.348.9500 ext. 1501 2006 Arthrotek, Inc. All Rights Reserved

web site: www.arthrotek.com eMail: [email protected]

Form No. Y-BMT-979/071506/K

I N V E N T I N G T H E F U T U R E O F A R T H R O S C O P Y

2015 OS - Fanelli Surgery Powerpoint

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