TREATMENT

TREATMENT RESULTS: JUNE, 1997


SUMMARY REPORT, VOLUME 3, JUNE, 1997

PREOPERATIVE - OVERALL CONDITION:

In the last 5 years, 66% of the ACI treated knees had at least one prior surgery to treat an articular cartilage injury. Of the 315 knees treated with ACI in this report, a total of 305 surgical procedures were performed to treat articular cartilage injury.

Mean Preoperative Status: All patients rated between fair and poor based on a Modified Cincinnati Knee Rating Scale (2 being poor and 10 excellent) prior to ACI surgery.

POSTOPERATIVE - OVERALL CONDITION:

  • Note: Based upon a modified Cincinnati Knee Rating System
    p1. p - value tests change from baseline to 12 months
    p2. p - value tests change from 6 months to 12 months
  • Clinician Evaluation at 6 & 12 Months Compared to Baseline: 80% of patients were evaluated as improved at 12 months post-treatment.

    		Improvement No Change Worsening Mean Change in Score*
    6 Month 74.2% 17.2% 8.6% +2.35
    12 Month 80.2% 14.8% 4.9% +3.53
    *Based on modified Cincinnati Knee Rating System, with a scale of 0-10 (2=poor 10=excellent)

    • KNEE EXAMINATION:

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

    PATIENT REPORTED SYMPTOMATOLOGY:*

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


    *Based on modified Cincinnati Knee Rating System, with a scale of 0-10 (2=poor 10=excellent)

    SAFETY PROFILE:

    • 87.6% of the patients reported no adverse events or complications following implantation.
    • 21 of the 460 treated knees (4.6%) had a complication considered to be at least possibly related to ACI.
    • Adhesions / fibroarthrosis (3.3% of procedures) and hypertrophic changes (2.6% of procedures) were the most frequent of the 460 treated knees.

    REGISTRY PARTICIPATION:

    • 227 surgeons in both U.S. and Europe
    • 312 patients (315 knees treated)
    • 191 patients (193 knees) with 6 month follow-up
    • 84 patients (84 knees) with 12 month follow-up

    PATIENT PROFILE:

    • Age: 97% >15 Years and < 55 Years; Average age = 36
    • Defect Location:


    • Defect Grade: 95% Grades III and IV
    • Area: 4.1 cm 2

    CONCLUSIONS:

    • ACI, at both 6 and 12 month intervals, continues to appear safe and effective.
    • Statistically significant improvement is seen at both 6 and 12 months for overall knee condition, patient reported symptomatology and knee examination results.
    • Subsequent registry reports will present analyses including 24 month outcomes data.
    • Data indicates that most improvements noted at 6 months remain durable or improved further at 12 months.


    For Earlier Patient Registry Reports:
    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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    Last Update: 04/03/2003
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