See Important Safety Information for CARTICEL. C-00089.B 7/2008 CARTICEL ® Case Studies Bennett...

See Important Safety Information for CARTICEL.

C-00089.B 7/2008

CARTICEL® Case Studies

Bennett Orthopedics & Sportsmedicine

Regenerating the Youth in You!

William F Bennett MD

Orthopedic Surgeon


C-00089.B 07/2008

Case Study TemplatePatient Description

Age

Gender

Date of knee injury

Symptoms

Previous surgery (s)

List of co-morbidities (if any)– Joint stability

– Alignment

– Meniscal pathology

Employment & activities of relevance

Patient expectations (what do they want to return to?)


C-00089.B 07/2008

Case Study TemplateClinical Results

Improvement in Symptoms

Level of Activity– Activities of daily living

– Return to sports and recreation

– Limitations

Second Look Images (if any)


C-00089.B 07/2008

CARTICEL Case Study #1

31 year-old male Air Force mechanic.

Recreational basketball player.

Acute basketball injury occurring in June 2004.

– Patient presented patello-femoral instability of the left knee.

Patient desires to return to sports activities.

Case study and images courtesy of Jason M. Scopp, MD. Salisbury, MD.


C-00089.B 07/2008

CARTICEL Case Study #1:Clinical Findings

Pre-operative findings– X-ray revealed normal joint space and patella

orientation.

– Patient stated during the H & P that he “dislocated his knee cap” while playing basketball.

Arthroscopic Evaluation– 2.0 cm X 2.0 cm (4.0 cm2)

trochlear defect on the left knee treated with chondroplasty, which subsequently failed.

– Confirmed lateral subluxation of patella.

– Biopsy taken for CARTICEL implantation.



C-00089.B 07/2008

CARTICEL Case Study #1:Implantation

CARTICEL implantation occurred after patient failed to respond to initial chondroplasty.

– Following tibial tubercle osteotomy (Fulkerson) cut to correct lateral subluxation, the patella was reflected, exposing the trochlea defect.

– CARTICEL was implanted and periosteal patch was sewn into place.



C-00089.B 07/2008

CARTICEL Case Study #1:Clinical Results

Second-Look Arthroscopy

– Underwent a second look arthroscopy 9 months after implantation when patient re-injured knee (patient’s son bumped into the knee).

– Integrated, restored cartilage congruent with joint surface of the trochlea.

Clinical Outcome

– Patient completed rehabilitation program, returned to work and recreational sports, and continues to play basketball regularly.

– Patient does not have any limitation with regards to desired level of activity.Case study and images courtesy of Jason M. Scopp, MD. Salisbury, MD.


C-00089.B 07/2008

CARTICEL Case Study #2:

35 year-old male assembly line worker

Recreational basketball player and high school football coach

Sustained injury while playing basketball in April of 2005

– Patient presented with pain, edema and instability in the right knee.

Patient desires to return to sports activities.

Case study and images courtesy of Akbar Nawab, MD. Louisville, KY.


C-00089.B 07/2008


Co-Morbidities

– Pre-operative MRI revealed a complete ACL tear, medial and lateral meniscus tears, all which were repaired at the time of initial arthroscopy.

– No malalignment.



C-00089.B 07/2008


Initial arthroscopy– Large 8.75 cm2 (2.5 cm X 3.5 cm) MFC

lesion with detached cartilage segment.

– Lesion was treated with debridement, which subsequently failed.

– Detached articular cartilage segment in interchondylar notch was removed.

– Biopsy taken for CARTICEL implantation.

– ACL was reconstructed and menisci were repaired at this time.



C-00089.B 07/2008

CARTICEL Case Study #2:Implantation

CARTICEL Implantation occurred after patient failed to respond to initial debridement.

MFC defect after debridement.

Periosteal harvest from tibia.

MFC defect post-implantation.



C-00089.B 07/2008

CARTICEL Case Study #2:Clinical Results

Second-Look Arthroscopy

– Arthroscopic evaluation 22 months post CARTICEL implantation.

– Loose meniscal suture anchor was removed.

– Meniscus tear healed and ACL was stable.

– Integrated, restored cartilage congruent with joint surface of the MFC.

Clinical Outcome

– Patient completed rehabilitation program and resumed work as assembly line laborer.

– Full return to playing basketball and coaching football.

– No complaints of instability.

– No pain after loose anchor removal.

Case study and images courtesy of Akbar Nawab, MD

Integrated MFC with no hypertrophy or delamination



C-00089.B 07/2008

Important Treatment Considerations

CARTICEL is for autologous use and is indicated for the repair of symptomatic cartilage defects of the femoral condyle (medial, lateral or trochlea), caused by acute or repetitive trauma, in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure (e.g., debridement, microfracture, drilling/abrasion arthroplasty, or osteochondral allograft/autograft). CARTICEL should only be used in conjunction with debridement, placement of a periosteal flap and rehabilitation. The independent contributions of the autologous cultured chondrocytes and other components of the therapy to outcome are unknown. It is not indicated for the treatment of cartilage damage associated with generalized osteoarthritis. It is not recommended for patients whose knee meniscus has been surgically removed unless the patient has undergone surgical reconstruction prior to or concurrent with CARTICEL implantation.

Pre-existing conditions including meniscal tears, joint instability or malalignment of the joint should be corrected prior to or concurrent with CARTICEL implantation. It should not be used in patients with a known history of hypersensitivity to gentamicin, other aminoglycosides or materials of bovine origin. CARTICEL is not routinely tested for transmissible infectious diseases and may transmit disease to the healthcare provider handling CARTICEL. In addition, it should not be used in patients who have previously had cancer in the bones, cartilage, fat or muscle of the treated limb. Use in children, patients over age 65, or in joints other than the knee has not yet been assessed.

The occurrence of subsequent surgical procedures (SSPs), primarily arthroscopy, following CARTICEL implantation is common. In the Study of the Treatment of Articular Repair (STAR), forty-nine percent (49%) of patients underwent an SSP on the treated knee, irrespective of their relationship to CARTICEL, during the 4-year follow-up. The most common serious adverse events (≥5% of patients), derived from STAR, include arthrofibrosis/joint adhesions, graft overgrowth, chondromalacia or chondrosis, cartilage injury, graft complication, meniscal lesion, graft delamination, and osteoarthritis.

See Important Safety Information for CARTICEL. C-00089.B 7/2008 CARTICEL ® Case Studies Bennett...

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