Taperloc Tech. - for pdf - Ormedic DE... · Engh Presentation, ... Place the retractable calcar...

14
taperloc ® : Spanning the generations surgical technique

Transcript of Taperloc Tech. - for pdf - Ormedic DE... · Engh Presentation, ... Place the retractable calcar...

taperloc®:

Spanning the

generations

surgical technique

TAPERLOC® HIP SYSTEM

The Taperloc® stem is designed after the

European philosophy of a fl at tapered wedge. By

combining excellent clinical success and durability

over the last 20 years, the Taperloc® hip continues to

deliver consistent, reproducible results.

KEY DESIGN FEATURES:• Flat tapered wedge geometry

• Titanium alloy Ti-6AL-4V

• 50% of stem is circumferentially plasma spray

• Rotational stability

• Offset option

• Simple and accurate Exact™ Instrumentation

the taperloc® hip

system unites the

benefi ts of:

• excellent clinical

results

• a tapered geometry

• superior materials

and manufacturing

methods

• enhanced

performance

and reliability

taperloc® hip System...simply the best

• Tapered Geometry Enhances Proximal

Offl oading and Bone Preservation

The Taperloc® stem is collarless to

allow for self-seating of the implant

between the lateral and medial cortices of

the femoral canal. The tapered portion of

the stem provides a wedge effect in the

medullary canal producing a “fi t” instead

of a “fi t and fi ll” (Figure 1). This provides

rotational and axial loading with a proven

lower incidence of thigh pain.5, 9–11

• The Flexibility of Titanium

Alloy Provides Natural Load

Transfer and Tissue Strength

Titanium plays a critical role

in implant performance because

of its excellent biocompatibility

and a low modulus of elasticity

that closely resembles that of bone. The

fl exibility of the titanium allows for an

additional avenue of stress transfer through

the femur/implant interface that results in

a femur which sustains load and preserves

cortical density.

• The Precision of Modern Digital

Manufacturing

Recent developments in 3-dimensional

solid modeling technologies allow for accurate

interpretation of complex implant geometries.

Net forgings produced by this 3-dimensional

CAD-CAM technology provide the most

precise fi t possible for the implant.

Largest group of patients: 12-year follow-up / 99.6% survivorship of 4,750 hips6

Youngest group of patients:13-years follow-up / 98% survivorshipof 100 hips with 100% follow-up /Average age: 37 years10

Oldest group of patients:2–11 years follow-up / 100% survivorshipof 92 hips / Average age: 84.5 years7

Figure 1 – Flat Wedge & IM Rod

• Circumferential Plasma Spray Promotes

Better Initial Fixation and a More Complete Seal

Biomet’s circumferential plasma spray porous coating

is designed for optimal fi xation. The non-intercon-

nected pores act to create a seal from particulate

debris migration. This construct may reduce femoral

osteolysis and improve long-term fi xation.3, 4, 13

Biomet’s proprietary plasma spray application is

unique in that only the titanium alloy powder used

to create the coating is heated, while the implant’s

substrate is retained at near ambient temperatures.

Application of the plasma spray porous coating to the substrate of the implant at a low

temperature helps preserve up to 90% of the mechanical strength of the implant (Figure 2).1, 2

During the plasma spray process, randomly shaped particles are injected through a plasma

fl ame and fl attened upon impact with the substrate. The resulting surface is rough on a micro-

and macro-level, in contrast to the smooth surfaces of a beaded implant. This unique feature

of surface roughness allows the implant to scrape bone into the pores during implantation.

In addition, random particle dimensions result in a varied pore size distribution. Smaller pores

are important for initial fi xation as they promote early osseo integration thus preventing

early micromotion. Larger pores require a longer time to fi ll in and provide for long-term

fi xation with continued bone in-growth. This pore in-growth is important for stress transfer at

1

Author Reference Hip Implant System Years Followed Osteolysis

Evans and DeLee Submitted for Publication Bi-Metric® (Biomet) 5–10 years 0.0% Mauerhan, et al. J. Arthroplasty, 1997 Integral® (Biomet) 5–8 years 0.0% McLaughlin JBJS Taperloc® (Biomet) 8–12.5 years 6.0% Head, et al. Orthopedics, 1999 Mallory-Head® (Biomet) 11 years avg. 0.0% Rothman Orthopedics, 1994 Taperloc® (Biomet) 7 years 3.0% Bourne, et al. Hip Society (March), 2001 Mallory-Head® (Biomet) 10–13 years 0.0% Multi-Center Study Biomet Clinical Report, 1994 Taperloc®, Mallory-Head® 5 years 0.4% Bi-Metric®, Integral® (Biomet) Capello, McClain Trans. Int’l Sym., 1992 Omnifi t® (Osteonics) 2–6 years 44.7% Heekin, et al. JBJS, 1993 PCA® (Howmedica) 5–7 years 18.0% Woolson, Maloney J. Arthroplasty, 1992 Harris/Galante™ (Zimmer) 3.5 yrs. avg. follow-up 22.0% Kim, et al. Orthop. Trans, 1992–3 PCA® (Howmedica) 2–7 years 37.0% Kim, et al. Orthop. Trans, 1992–3 AML® (DePuy) 2–7 years 55.8% Smith, Harris CORR, 1995 Harris/Galante™ (Zimmer) 4.5 yrs. avg. follow-up 31.0% Engh Presentation, 1992 AML® (DePuy) 7.5 yrs. avg. follow-up 28.0% Engh Presentation, 2001 AML® (DePuy) 13.9 yrs. follow-up 40.0%

POROUS COATING VS. OSTEOLYSIS

0

10

20

30

40

50

60

70

80

Sintered or Diffusion Bonded

Plasma Sprayed

Sintered or Diffusion Bonded

Plasma Sprayed

Ti and Ti Alloy Co-Cr Alloy

Fatig

ue S

treng

th (k

si) at

107 C

ycles

Range of values determinedRange of values reported

Figure 2 – Effect of the porous coating method on fatigue strength.8

Above is a SEM photograph at 100x magnifi cation showing plasma spray porous coating.

later stages. Studies have shown that “rough

titanium has been found to have a good

propensity for encouraging adhesion of

osteoblasts”.11, 12 Biomet’s porous coating

offers .5mm to .75mm press fi t per side on

the porous coated area.

Figure 4 – Lateral Offset

Figure 3 – Regular Offset

• Offsets:

Reproducing femoral offset is recognized

as an important feature of any total hip system.

The Taperloc® system offers two offset

features for each primary stem size, standard

and lateralized (Figures 3 & 4). Availability

of a lateral offset design allows the surgeon

to enhance stability without lengthening the

leg. This allows for restoration of normal hip

biomechanics. The capability of increasing

the offset of the Taperloc® stem by 7.8mm is

achieved via a straight horizontal shift of the

trunion and lengthening of the taper.FLAP OFF PG. 1 – (INSIDE OF)

FLAP OFF PG. 1 – (BACK OF)

INSTRUMENTATIONWith the Taperloc® Hip System, only two trays are needed for implantation: the

Exact™ General I and the Taperloc® System Specifi c tray. Streamlined and accurate system

specifi c trays provide for the ultimate in O.R. effi ciency while the recognizable color-coding

(Taperloc® system specifi c is green) identifi es the instrumentation specifi c to the femoral

component selected.

KEY COMPONENTS OF THE EXACT™ INSTRUMENTATION ARE: A Starter Reamer allows for the initial opening of the femoral canal.

The Offset Chisel provides a direct view for initial opening of the

femoral canal.

Incrementally sized Magnetic Neck Trunions in standard and

lateralized offsets offer accurate intraoperative biomechanical adjust-

ment during trial reduction. Standard is gold and lateralized is black.

The Femoral Inserter screws into the implant to give the implant

version control upon insertion into the femur.

The Taperloc® Neck Resection Guide offers the versatility of medial

and vertical radius reference points from the greater and lesser

trochanter respectively. A convenient trochanter stop assists in marking

the level of measurement.

the exact™ hip

instrumentation

provides for

versatility,

fl exibility and

simplicity.

General Case 1

The following Exact™ Hip Instrumentation cases are needed to implant the Taperloc®:

Taperloc® Broaches

General Case II (Extraction) – Open only if needed

taperloc® System/ exact™ instrumentation experience

2

A Broach Handle provides solid engagement with a quick,

easy trigger locking mechanism that affords a clear view and a

rapid release. A large impaction plate provides

for solid driving contact.

Broaches are fully toothed to provide the effi cient

removal of cancellous bone to contour a pocket for

the implant. These newly designed broaches are

created utilizing the same data set used to produce

the implant. Included is an improved cutting tooth

pattern that is nitrided to prolong the life of the

cutting edges.

X-RAY TEMPLATES: PREOPERATIVE PLANNING

The new Exact™ Template system offers a precise mode for implant sizing and

preoperative evaluation of anatomic offset. Vertical and medial scales correspond to the

resection guide to aid in leg length restoration. The templates are designed to match the

color-coded instrument case for ease of identification and offer a table for quick offset

references.

Taperloc® Hip Template

3

Preoperative x-ray with new Taperloc® Hip Template

PATIENT POSITIONING AND SURGICAL APPROACH

The goal of the surgical approach is to establish adequate visualization of the

anatomy so that the entire surgical area is exposed.

The patient should be placed in a full lateral position secured with positioning

devices to ensure complete patient stability. An anterolateral approach via a lateral

curvilinear incision is recommended (Figs. 1 & 2).

FEMORAL NECK RESECTIONThe Exact™ Taperloc® Femoral Resection Guide may be used to mark the

neck resection level for an accurate cut. It utilizes key reference points off of the

lesser and greater trochanters which correspond to the measurements on the Exact™

Templates. For example: When templating the x-rays, note the measurement on

the vertical and medial scales that line up with the greater and lesser trochanters.

Place the resection guide on the femur and line up the vertical scale with the

greater trochanter. If utilizing the greater trochanter stop, pre-set it to the closest

mark noted during templating. With the trochanteric stop resting on the greater

trochanter, the medial markings should correspond to your preoperative planning.

For example, if you measured +7 on the template, then place the trochanteric stop

at the +5mm mark, erring on the side of preserving bone. Once the appropriate

level of resection has been determined, proceed with cutting the femoral neck to

allow for re-creation of the appropriate femoral neck length and offset (Fig. 3).

the taperloc® femoral

component combines

unmatched clinical

success with the new

innovative design of exact™

instruments to provide

accurate and reproducible

implantation.

Fig. 1

Fig. 3

the taperloc® hip surgical technique

4

Fig. 2

ACCESSING THE FEMORAL CANALThe Exact™ Offset Chisel is used to determine the orientation of the femoral

canal and access the lateral section of the proximal femur. This helps to clear a

channel laterally to accept the starter reamer without interference from the dense

bone surrounding the trochanter. The design of the offset chisel assures adequate

visualization to allow enough lateralization of the femoral canal to avoid varus

positioning of the component (Fig. 4).

A single starter reamer on a T-handle may be used to initiate the opening into

the distal femoral canal to a level appropriate to the size component templated on

the preoperative x-rays (Fig. 5).

CONTOURING THE STEM ENVELOPEAfter opening the canal, a Taperloc® broach is used to contour the proximal

stem envelope. Attach the broach handle to the broach by pulling back on the

trigger to engage the broach. Begin the broaching process with the smallest

Taperloc® broach. Orientation of the broach should take into account the medial/

lateral and anterior/posterior position of the medullary canal. Progressively increase

the broach size to enlarge the envelope until the broach engages the medial and

lateral cortex and can not be advanced deeper or until the templated implant size

is reached. Use care with insertion and removal of each broach to avoid excessive

rotation and preserve the version of the femoral envelope (Fig. 6).

The modularity of the broaches allow for rapid sequential broaching and the

ability to accurately trial directly off of the broaches using the new magnetic neck

trunions.

PLANING THE FEMURPlaning a collarless implant is at the surgeon’s discretion. With the fi nal broach

fully seated, remove the broach handle. Place the retractable calcar planer over the

short post of the broach and machine the femoral neck for optimal implant contact

(Fig. 7). The calcar planer is specially designed to work in conjunction with the

short broach post to prevent metal-to-metal wear of the post.

Fig. 6

5

Fig. 7

Fig. 4

Fig. 5

Fig. 11

TRIAL REDUCTIONTo perform the trial reduction with the indwelling

broach, attach the Exact™ Taperloc® magnetic neck trials,

standard or lateralized, onto the broach post. These

trunions are color coded to represent offset. The gold trun-

ion indicates standard offset while the black represents

lateralized offset. The Exact™ Magnetic Trunions are sized

to correspond to the fi nal broach, and the stem size is

clearly marked on the top of the trunion (Fig. 8). Once

the appropriate trunion is in place, select the trial femoral

head of desired diameter and neck length. Reduce the hip

and evaluate the joint for soft tissue tension, anterior and

posterior stability, and stability in the sleep position. If any additional adjustments

to neck length and/or offset are needed they can be completed at this time (Fig. 9).

STEM INSERTIONOnce the trial reduction is considered stable, remove the broach from the

femoral canal and attach the implant to the threaded femoral inserter (Fig. 10).

The femoral inserter handle assists in controlling rotation of the implant and

enables the implant to be inserted into the femoral envelope with the proper

amount of anteversion. Care should be taken to orient the implant parallel to

the prepared envelope, matching the appropriate amount of anteversion that was

determined from the broaching step. The stem should slide distally into the canal

without much resistance until the implant engages the lateral and medial wall of

the prepared canal. Gently tap to seat the prosthesis. Remove the inserter when

the implant is fully seated. A trial head component can be placed on the femoral

implant neck trunion for an additional trial reduction or the selected modular

femoral head can be fi rmly impacted onto the clean dry taper (Fig. 11).

Fig. 10

the taperloc® hip surgical technique

Fig. 9

Fig. 8

6

This brochure demonstrates the surgical technique of Jeffery McLaughlin, M.D. Biomet as the manufacturer of this device, does not practice medicine and does not recommend this or any other surgical technique for use on a specifi c patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting the prosthesis in each individual patient. Biomet is not responsible for selection of the appropriate surgical technique to be utilized for an individual patient.

7

HEAD OPTIONS

-5mm -3mm Std.

-6mm -3mm Std. +3mm +6mm +9mm +12mm

-3mm Std.

-5mm -3mm Std. +3mm +6mm

Available in both standard and lateral offset options.

7.5mm9.0mm

10.0mm11.0mm12.5mm13.5mm15.0mm17.5mm20.0mm22.5mm

the taperloc® stem grows

incrementally with each stem

size. The medial curvature

remains constant for each size

and grows outward laterally.

taperloc® offset and ordering information

STANDARD TAPERLOC® POROUS PRIMARY

8

LATERALIZED TAPERLOC® POROUS PRIMARY

Size Stem Neck Horizontal Offset Vertical Offset Neck Length Length Angle

-6 -3 STD +3 +6 +9 +12 -6 -3 STD +3 +6 +9 +12 -6 -3 STD +3 +6 +9 +12

7.5mm 135mm 138° 39.0 41.0 43.0 45.0 47.0 49.0 51.0 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

9.0mm 137mm 138° 39.8 41.8 43.8 45.8 47.8 49.8 51.8 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

10.0mm 140mm 138° 40.3 42.3 44.3 46.3 48.3 50.3 52.3 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

11.0mm 142mm 138° 40.8 42.8 44.8 46.8 48.8 50.8 52.8 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

12.5mm 145mm 138° 41.5 43.5 45.5 47.5 49.5 51.5 53.5 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

13.5mm 147mm 138° 42.0 44.0 46.0 48.0 50.0 52.0 54.0 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

15.0mm 150mm 138° 42.8 44.8 46.8 48.8 50.8 52.8 54.8 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

17.5mm 155mm 138° 44.0 46.0 48.0 50.0 52.0 54.0 56.0 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

20.0mm 160mm 138° 45.3 47.3 49.3 51.3 53.3 55.3 57.3 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

22.5mm 165mm 138° 46.5 48.5 50.5 52.5 54.5 56.5 58.5 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

25.0mm 170mm 138° 47.8 49.8 51.8 53.8 55.8 57.8 59.8 31.1 33.3 35.6 37.8 40.0 42.2 44.5 34.0 37.0 40.0 43.0 46.0 49.0 52.0

Size Stem Neck Horizontal Offset Vertical Offset Neck Length Length Angle

-6 -3 STD +3 +6 +9 +12 -6 -3 STD +3 +6 +9 +12 -6 -3 STD +3 +6 +9 +12

7.5mm 135mm 138° 31.3 33.3 35.3 37.3 39.3 41.3 43.3 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

9.0mm 137mm 138° 32.0 34.0 36.0 38.0 40.0 42.0 44.0 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

10.0mm 140mm 138° 32.5 34.5 36.5 38.5 40.5 42.5 44.5 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

11.0mm 142mm 138° 33.0 35.0 37.0 39.0 41.0 43.0 45.0 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

12.5mm 145mm 138° 33.7 35.7 37.7 39.7 41.7 43.7 45.7 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

13.5mm 147mm 138° 34.3 36.3 38.3 40.3 42.3 44.3 46.3 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

15.0mm 150mm 138° 37.0 37.0 39.0 41.0 43.0 45.0 47.0 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

17.5mm 155mm 138° 36.3 38.3 40.3 42.3 44.3 46.3 48.3 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

20.0mm 160mm 138° 37.5 39.5 41.5 43.5 45.5 47.5 49.5 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

22.5mm 165mm 138° 38.7 40.7 42.7 44.7 46.7 48.7 50.7 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

25.0mm 170mm 138° 40.0 42.0 44.0 46.0 48.0 50.0 52.0 30.5 32.7 35.0 37.2 39.4 41.6 43.9 28.3 31.3 34.3 37.3 40.3 43.3 46.3

TAPERLOC® FEMORAL COMPONENT

Exact™ Taperloc® Template

31-400164

Taperloc® Specifi c Cases:

Exact™ Taperloc® Broach Case

595104

Exact™ General Case I

595100

Exact™ General Case II

595101

TAPERLOC® MAGNETIC NECK TRUNIONS

Standard (Gold) Lateralized (Black) Sizes Part No. Sizes Part No.

7.5–9 31-103001 7.5–9 31-103004 10–15 31-103002 10–15 31-103005 17.5–25 31-103003 17.5–25 31-103006

Neck Angle138.0°

Taperloc® Standard and Lateralized Stems

Stem Stem Implant Implant Rasp/Prov. Size Length Standard Lateralized

7.5 135mm 103202 11-103202 31-103202

9.0 137mm 103203 11-103203 31-103203

10.0 140mm 103204 11-103204 31-103204

11.0 142mm 103205 11-103205 31-103205

12.5 145mm 103206 11-103206 31-103206

13.5 147mm 103207 11-103207 31-103207

15.0 150mm 103208 11-103208 31-103208

17.5 155mm 103209 11-103209 31-103209

20.0 160mm 103210 11-103210 31-103210

22.5 165mm 103211 11-103211 31-103211

25.0 170mm 103212 11-103212 31-103212

P.O. Box 587, Warsaw, IN 46581-0587 • 574.267.6639 • ©2002 Biomet Orthopedics, Inc. All Rights Reservedweb site: www.biomet.com • eMail: [email protected]

Form No. Y-BMT-745/022802/K

REFERENCES

1. Bourne, R.B.; et al.: “Ingrowth Surfaces: Plasma Spray Coating to Titanium Alloy Hip Replacements.” Clin. Orthop., 298: 37–46, 1994.

2. Collier, J.P.; Head, W.C.; Koeneman, J.; et al.: Symposium: “Porous Coating Methods: The Pros and Cons.” Contemporary Orthop., 27(3): 269–296, 1993.

3. Emerson, R.H.; Sanders, R.B.; Head, W.C.; Higgins, L.: “Effect of Circumferential Plasma-spray Porous Coating on the Rate of Femoral Osteolysis After Total Hip Arthroplasty.” J. Bone Joint Surg., 81-A: 1291–8, Sept. 1990.

4. Head, W.C.: “Mallory-Head Porous Press-Fit Primary Hip Replacement.” Presented at the Tenth Annual International Symposium: New Developments in Total Joint Reconstruction, Lake Tahoe, Nevada, June 14–16, 1993.

5. Hozack, W.; Rothman, R.; Eng, K.; Mesa, J.: “Primary Cementless Hip Arthroplasty with a Titanium Plasma Sprayed Prosthesis.” CORR, 33(3): 217–225, Dec. 1996.

6. Hozack, W.: “Ten Year Experience with a Wedge-Fit Stem.” Crucial Decisions in Total Joint Replacement and Sports Medicine, Bermuda, 1998.

7. Keisu, Kjell; Orozco, F.; Sharkey, P.; et al.:“Primary Cementless Total Hip Arthroplasty inOctogenarians: Two to Eleven Year Follow-up.” J. Bone Joint Surg., 83-A: 359–363, 2001.

8. Leudeman, R.: “The Effect of a Plasma Sprayed Porous Ti-Alloy Coating on the Rotation Beam Fatigue Strength of Co-Cr-Mo Alloy.” Biomet Technical Report, 1994.

9. McLaughlin, J.R.; Lee, K.R.: “Total Hip Arthroplasty with an Uncemented Femoral Component.” J. Bone Joint Surg., 79-B: 900–907, 1997.

10. McLaughlin, J.R.: “Plasma Sprayed Porous-Coated Total Hip Arthroplasty: A 13-year Survivorship Analysis in Patients Age 50+ and Under.” Presented at the 63rd AAOS, San Francisco, 1997.

11. Sharkey, P.F.; et al.: “Initial Stability of a Collarless Wedge-Shaped Prosthesis in the Femoral Canal.” Seminars in Arthroplasty, 1(1): 87–90, July 1990.

12. Symposium: “Porous Coating Methods: The Pros and Cons.” Contemporary Orthop., 27(3): 469–296, Sept. 1993.

13. Tanzer, M.; et al.: “The Progression of Femoral Cortical Osteolysis in Association with Total Hip Arthroplasty without Cements.” J. Bone Joint Surg., 74-A: March, 1992.

Taperloc® is a registered trademark of Biomet, Inc.Exact™ is a trademark of Biomet, Inc.