TREATMENT

TREATMENT RESULTS - FEBRUARY 1998


SUMMARY REPORT, VOLUME 4, FEBRUARY, 1998

PREOPERATIVE - OVERALL CONDITION:

In the last 5 years, 62% of the ACI treated knees had at least one prior surgery to treat an articular cartilage injury. Of the knees treated with ACI in this report, 74% have had previous surgery.

POSTOPERATIVE - OVERALL CONDITION:
  • Clinician & Patient Evaluation of Overall Condition at 24 Months After Surgery Compared to Pre-Operative Baseline Condition

  • Note: Based upon a modified Cincinnati Knee Rating System. Treatment failures were assigned a "2" for follow-up.
  • Clinician & Patient Evaluation of Overall Condition at 24 Months After Surgery Compared to Pre-Operative Baseline Condition

CLINICIAN EVALUATION

n Improve % Same % Decline % Mean Change In Score*
MFC 25 80% 16% 4% (+) 3.80
LFC 5 100% 0% 0% (+) 5.20
Trochlea 4 100% 0% 0% (+) 3.25
Femur 43 86% 12% 2% (+) 4.14
Overall 50 78% 16% 6% (+) 3.64

PATIENT EVALUATION

n Improve % Same % Decline % Mean Change In Score*
MFC 25 72% 8% 20% (+) 2.76
LFC 4 100% 0% 0% (+) 5.50
Trochlea 4 75% 25% 0% (+) 2.50
Femur 42 79% 7% 14% (+) 3.43
Overall 49 74% 10% 16% (+) 3.02
  • *Note: Based upon a modified Cincinnati Knee Rating System with a scale of 0-10 (2=poor, 10=excellent).

    • KNEE EXAMINATION:

    • 24 Month Results Compared to Baseline: Significant declines in both joint line pain and swelling are evident.

      PATIENT REPORTED SYMPTOMATOLOGY:*

    • 24 Month Results Compared to Baseline: Significant declines in both joint line pain and swelling are evident at both 12 and 24 months post implantation.


      *Based on modified Cincinnati Knee Rating System, with a scale of 0-10 (2=poor 10=excellent). Treatment failures were assigned a "2" for follow-up.

    SAFETY PROFILE:

    • 87% of the patients (779) reported no adverse events or complications following implantation.
    • 5% had a complication considered to be at least possibly related to ACI.
    • Adhesions / fibroarthrosis (3% of procedures) and hypertrophic changes (2% of procedures) were the most frequent complication of the treated knees.
    • Cumulative incidence of treatment failure is 3.3% at 12 months and 5.8% at 24 months following implantation.
    Re-operation Rate
    • 90% of the patients treated did not report a re-operation to the registry.
    • Majority of the re-operations were performed arthroscopically. The most common procedures performed included shaving, trimming or debridement (6.5%) and manipulation/lysis of adhesions (2.4%).
    • 4.8% had a re-operation considered to be at least possibly related to the implantation.

    REGISTRY PARTICIPATION:

    • 273 patients with 12 month follow-up
    • 50 patients with 24 month follow-up

    PATIENT PROFILE:

    • Age: 97% >15 Years and < 55 Years; Average age = 35
    • Prior Surgery: 74% of the patients have had previous surgery and 62% have had pror surgery to treat articular surface injuries within the past five years.
    • Defect Location: 91% of the lesions are on the distal femur.
    • Area: 4.4 cm 2is the average size defect after debridment.

    CONCLUSIONS:

    • ACI (or AuCC), at both 12 and 24 month intervals, continues to appear to be safe and effective.
    • 86% of femoral condyle defect patients improve from the baseline condition, as rated by their physician.
    • 79% of femoral condyle defect patients rate themselves as improved from their baseline condition.
    • 87% of patients reported no adverse events.
    • 90% of patients reported no re-operation.
    • Incidence of failure is 3.3% at 12 months and 5.8% as 24 months after surgery.
    • Data indicates that improvements noted at 12 months for overall knee condition, patient symptomatology and knee examinaton results remain durable at 24 months.

    RECOMMENDATIONS:

    • Treating surgeons should closely adhere to the product labeling.
    • Procedure should not be used in patients with osteoarthritis, instability or abnormal loading or tracking of the knee.
    • Comprehensive data collection should become the standard for all evaluations of articular cartilage defects.


    For Earlier Patient Registry Reports:
    TREATMENT RESULTS: JUNE, 1997
    TREATMENT RESULTS - JANUARY, 1997

    (Courtesy of Genzyme Tissue Repair)


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    THIS MATERIAL DOES NOT CONSTITUTE MEDICAL ADVICE. IT IS INTENDED FOR INFORMATIONAL PURPOSES ONLY. PLEASE CONSULT A PHYSICIAN FOR SPECIFIC TREATMENT RECOMMENDATIONS.

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