TREATMENT

TREATMENT RESULTS - JANUARY, 1997


SUMMARY REPORT, VOLUME 2, JANUARY, 1997

PREOPERATIVE - OVERALL CONDITION:

In the last 5 years, 241 patients treated with ACI, included in this report, had a total of 305 surgical procedures 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

    		Improvement No Change Worsening Mean Change in Score*
    6 Month 72.4% 19.0% 8.6% +2.47
    12 Month 85.4% 9.8% 4.9% +3.73
    *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

    PATIENT REPORTED SYMPTOMATOLOGY:*

  • 12 Month Results Compared to Baseline


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

    SAFETY PROFILE:

    • 3.5% adverse event rate. Eleven of the 317 patients treated had a complication considered to be at least possibly related to ACI.
    • Adhesions / fibroarthrosis (3.2% of procedures) and hypertrophic changes (2.2% of procedures) were the most frequent.

    REGISTRY PARTICIPATION:

    • 146 surgeons in both U.S. and Europe
    • 241 patients treated
    • 139 patients with 6-month follow-up
    • 44 patients with 12-month follow-up

    PATIENT PROFILE:

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

      CONCLUSIONS:

      • Statistically significant improvement is seen at both 6 and 12 months for overall knee condition and patient symptomatology for femoral condyle defects <8 cm2.
      • Data indicates that most improvements noted at 6 months remain durable at 12 months and, as reported by clinician evaluation, improve significantly further.

      (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.

      THE CENTER FOR ORTHOPAEDICS AND SPORTS MEDICINE
      1211 JOHNSON FERRY RD.; MARIETTA, GA., 30068
      770-565-0011
      http://www.arthroscopy.com




    Last Update: 04/03/2003
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