TREATMENT

TREATMENT RESULTS - FEBRUARY 1999


SUMMARY REPORT, VOLUME 5, FEBRUARY, 1999

PREOPERATIVE - OVERALL CONDITION:

Of the knees treated with ACI in this report, 71% have had previous surgery. In an effort to specifically treat the articular cartilage defect, 59% have had prior surgery.

POSTOPERATIVE - OVERALL CONDITION:
  • Clinician & Patient Evaluation of Overall Condition at 36 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 or used exit data.
  • Clinician & Patient Evaluation of Overall Condition at 36 Months After Surgery Compared to Pre-Operative Baseline Condition

CLINICIAN EVALUATION

n Improve % Same % Decline % Mean Change In Score*
MFC 15 80% 13% 7% (+) 4.33
LFC 4 100% 0% 0% (+) 6.50
Trochlea 2 100% 0% 0% (+) 3.00
Femur 26 85% 8% 8% (+) 4.54
Overall 34 74% 18% 9% (+) 3.65

PATIENT EVALUATION

n Improve % Same % Decline % Mean Change In Score*
MFC 16 81% 13% 6% (+) 4.25
LFC 4 100% 0% 0% (+) 6.50
Trochlea 2 100% 0% 0% (+) 4.00
Femur 27 85% 7% 7% (+) 4.48
Overall 35 77% 11% 11% (+) 3.71
  • *Note: Based upon a modified Cincinnati Knee Rating System with a scale of 0-10 (2=poor, 10=excellent).

    • KNEE EXAMINATION:

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

      PATIENT REPORTED SYMPTOMATOLOGY:*

    • 36 Month Results Compared to Baseline: Significant declines in both joint line pain and swelling are evident at both 24 and 36 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 or used exit data.

    SAFETY PROFILE:

    • 90% of the patients (1896) 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 estimated using the survival table epidemiological analysis. The cumulative incidence is 3.2% at 24 months and 4.7% at 36 months following implantation.
    Re-operation Rate
    • 91% of the patients treated did not report a re-operation to the registry following implantation.
    • Majority of the re-operations were performed arthroscopically. The most common procedures performed included shaving, trimming or debridement (6%) and manipulation/lysis of adhesions (2%).
    • 5% had a re-operation considered to be at least possibly related to the implantation.

    REGISTRY PARTICIPATION:

    • 558 patients with 12 month follow-up
    • 220 patients with 24 month follow-up
    • 40 patients with 36 month follow-up

    PATIENT PROFILE:

    • Age: 97% >15 Years and < 55 Years; Average age = 35
    • Prior Surgery: 71% of the patients have had previous surgery and 59% have had prior surgery to treat articular surface injuries within the past five years.
    • Defect Location: 90% of the lesions are on the distal femur.
    • Area: 4.6 cm 2 is the average size defect after debridement. 80% of the lesions are greater than or equal to 2 cm 2.

    CONCLUSIONS:

    • ACI (or AuCC), at both 24 and 36 month intervals, continues to appear to be safe and effective.
    • 80% of medial femoral condyle defect patients improve from the baseline condition, as rated by their physician.
    • 81% of medial femoral condyle defect patients rate themselves as improved from their baseline condition.
    • 100% of lateral femoral condyle defect patients improve from the baseline condition, as rated by their physician.
    • 100% of lateral femoral condyle defect patients rate themselves as improved from their baseline condition.
    • 90% of patients reported no adverse events.
    • 91% of patients reported no re-operation.
    • Incidence of failure is 3.2% at 24 months and 4.7% at 36 months after surgery.
    • Data indicates that improvements noted at 12 and 24 months for overall knee condition, patient symptomatology and knee examination results remain durable at 36 months.

    RECOMMENDATIONS:

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


    For Earlier Patient Registry Reports:
    TREATMENT RESULTS - FEBRUARY 1998
    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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