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A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial.

Abstract

BACKGROUND

This is a prospective clinical study to assess the effectiveness of autologous chondrocyte implantation in patients who failed prior treatments for articular cartilage defects of the knee.

HYPOTHESIS

Autologous chondrocyte implantation provides clinical benefit in patients with failed articular cartilage treatments.

STUDY DESIGN

Cohort study; Level of evidence, 2.

METHODS

One hundred fifty-four patients with failed treatment for articular cartilage defects of the knee received autologous chondrocyte implantation in a multicenter, prospective study. Follow-up was 48 months. Outcomes included change from baseline in knee function, knee pain, quality of life, and overall health. Duration of benefit after autologous chondrocyte implantation was compared with the failed prior non-autologous chondrocyte implantation procedure. Safety information was recorded. Additional analyses were performed on the 2 major cohorts of prior procedures entered into the study, marrow-stimulation technique or debridement alone, to assess if there were any significant differences in baseline characteristics, outcomes, or prognosis between the 2 groups.

RESULTS

One hundred twenty-six patients (82%) completed the protocol. Seventy-six percent of patients were treatment successes at study end, while 24% were deemed treatment failures. Preoperative mean knee pain score was 3.0 (SD, 1.8; 0 = severe, 10 = normal). Mean improvements were observed from baseline to all time points (P < .001) for all outcome measures. Preoperative to 48-month values, respectively, were as follows: On the Knee injury and Osteoarthritis Outcome Score subscales of pain: 48.7 to 72.2; other symptoms: 51.8 to 70.8; sports/recreation: 25.8 to 55.8; knee quality of life: 20.9 to 52.2; and activities of daily living: 58.6 to 81.0; on the Modified Cincinnati Overall Knee score: 3.3 to 6.3; on the visual analog scale: 28.8 to 69.9; and on the SF-36 Overall Physical Health: 33.0 to 44.4. Results did not differ between patients whose primary surgery had been a marrow-stimulating procedure and those whose primary procedure had been a debridement alone. The median difference in duration of benefit between autologous chondrocyte implantation and the failed non-autologous chondrocyte implantation prior procedure was at least 31 months (P < .001). Seventy-six patients (49%) had subsequent surgical procedure(s), predominantly arthroscopic. Need for a subsequent surgical procedure was not predictive of failure.

CONCLUSION

Patients with moderate to large chondral lesions with failed prior cartilage treatments can expect sustained and clinically meaningful improvement in pain and function after autologous chondrocyte implantation. The subsequent surgical procedure rate observed in this study (49% overall; 40% related to autologous chondrocyte implantation) appears higher than generally reported after autologous chondrocyte implantation.

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  • Authors+Show Affiliations

    ,

    Department of Orthopedic Surgery, Advanced Orthopedic Centers, Virginia Commonwealth University, Richmond, VA 23294, USA. kzaslav@aocortho.com

    , , , , , ,

    Source

    MeSH

    Adult
    Cartilage, Articular
    Chondrocytes
    Female
    Humans
    Knee Joint
    Male
    Outcome Assessment (Health Care)
    Prospective Studies
    Transplantation, Autologous
    Treatment Failure

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    18927254

    Citation

    Zaslav, Kenneth, et al. "A Prospective Study of Autologous Chondrocyte Implantation in Patients With Failed Prior Treatment for Articular Cartilage Defect of the Knee: Results of the Study of the Treatment of Articular Repair (STAR) Clinical Trial." The American Journal of Sports Medicine, vol. 37, no. 1, 2009, pp. 42-55.
    Zaslav K, Cole B, Brewster R, et al. A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial. Am J Sports Med. 2009;37(1):42-55.
    Zaslav, K., Cole, B., Brewster, R., DeBerardino, T., Farr, J., Fowler, P., & Nissen, C. (2009). A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial. The American Journal of Sports Medicine, 37(1), pp. 42-55. doi:10.1177/0363546508322897.
    Zaslav K, et al. A Prospective Study of Autologous Chondrocyte Implantation in Patients With Failed Prior Treatment for Articular Cartilage Defect of the Knee: Results of the Study of the Treatment of Articular Repair (STAR) Clinical Trial. Am J Sports Med. 2009;37(1):42-55. PubMed PMID: 18927254.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A prospective study of autologous chondrocyte implantation in patients with failed prior treatment for articular cartilage defect of the knee: results of the Study of the Treatment of Articular Repair (STAR) clinical trial. AU - Zaslav,Kenneth, AU - Cole,Brian, AU - Brewster,Robert, AU - DeBerardino,Thomas, AU - Farr,Jack, AU - Fowler,Peter, AU - Nissen,Carl, AU - ,, Y1 - 2008/10/16/ PY - 2008/10/18/pubmed PY - 2009/5/7/medline PY - 2008/10/18/entrez SP - 42 EP - 55 JF - The American journal of sports medicine JO - Am J Sports Med VL - 37 IS - 1 N2 - BACKGROUND: This is a prospective clinical study to assess the effectiveness of autologous chondrocyte implantation in patients who failed prior treatments for articular cartilage defects of the knee. HYPOTHESIS: Autologous chondrocyte implantation provides clinical benefit in patients with failed articular cartilage treatments. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: One hundred fifty-four patients with failed treatment for articular cartilage defects of the knee received autologous chondrocyte implantation in a multicenter, prospective study. Follow-up was 48 months. Outcomes included change from baseline in knee function, knee pain, quality of life, and overall health. Duration of benefit after autologous chondrocyte implantation was compared with the failed prior non-autologous chondrocyte implantation procedure. Safety information was recorded. Additional analyses were performed on the 2 major cohorts of prior procedures entered into the study, marrow-stimulation technique or debridement alone, to assess if there were any significant differences in baseline characteristics, outcomes, or prognosis between the 2 groups. RESULTS: One hundred twenty-six patients (82%) completed the protocol. Seventy-six percent of patients were treatment successes at study end, while 24% were deemed treatment failures. Preoperative mean knee pain score was 3.0 (SD, 1.8; 0 = severe, 10 = normal). Mean improvements were observed from baseline to all time points (P < .001) for all outcome measures. Preoperative to 48-month values, respectively, were as follows: On the Knee injury and Osteoarthritis Outcome Score subscales of pain: 48.7 to 72.2; other symptoms: 51.8 to 70.8; sports/recreation: 25.8 to 55.8; knee quality of life: 20.9 to 52.2; and activities of daily living: 58.6 to 81.0; on the Modified Cincinnati Overall Knee score: 3.3 to 6.3; on the visual analog scale: 28.8 to 69.9; and on the SF-36 Overall Physical Health: 33.0 to 44.4. Results did not differ between patients whose primary surgery had been a marrow-stimulating procedure and those whose primary procedure had been a debridement alone. The median difference in duration of benefit between autologous chondrocyte implantation and the failed non-autologous chondrocyte implantation prior procedure was at least 31 months (P < .001). Seventy-six patients (49%) had subsequent surgical procedure(s), predominantly arthroscopic. Need for a subsequent surgical procedure was not predictive of failure. CONCLUSION: Patients with moderate to large chondral lesions with failed prior cartilage treatments can expect sustained and clinically meaningful improvement in pain and function after autologous chondrocyte implantation. The subsequent surgical procedure rate observed in this study (49% overall; 40% related to autologous chondrocyte implantation) appears higher than generally reported after autologous chondrocyte implantation. SN - 1552-3365 UR - https://www.unboundmedicine.com/medline/citation/18927254/A_prospective_study_of_autologous_chondrocyte_implantation_in_patients_with_failed_prior_treatment_for_articular_cartilage_defect_of_the_knee:_results_of_the_Study_of_the_Treatment_of_Articular_Repair__STAR__clinical_trial_ L2 - http://journals.sagepub.com/doi/full/10.1177/0363546508322897?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -