CARTICEL® Case Studies

C-00089.B 7/2008

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Case Study Template

Patient 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

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Case Study Template

Clinical 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

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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

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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.

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

C-00089.B 07/2008

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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.

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

C-00089.B 07/2008

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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

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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

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CARTICEL Case Study #2:

Clinical Findings

 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.

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

C-00089.B 07/2008

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CARTICEL Case Study #2:

Clinical Findings

 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.

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

C-00089.B 07/2008

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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.

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

C-00089.B 07/2008

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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.

Integrated MFC with no

hypertrophy or delamination

Case study and images courtesy of Akbar Nawab, MD

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

C-00089.B 07/2008

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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.

C-00089.B 07/2008

See Important Safety Information for CARTICEL.