Design of a randomized controlled trial to compare debridement to observation of chondral lesions encountered during partial meniscectomy: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

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• 作者：Leslie J. Bisson ; ^{ljbisson@buffalo.edu" class="auth_mail" title="E-mail the corresponding author} ; Melissa A. Kluczynski ; William M. Wind ; Marc S. Fineberg ; Geoffrey A. Bernas ; Michael A. Rauh ; John M. Marzo ; Robert J. Smolinski
• 关键词：Meniscus tear ; Chondral lesion ; Arthroscopy ; Debridement ; Randomized controlled trial
• 刊名：Contemporary Clinical Trials
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：45
• 期：part_PB
• 页码：281-286
• 全文大小：326 K

文摘

Few studies have examined whether chondral lesions encountered in patients undergoing meniscectomy should be surgically treated. The primary aim of the ChAMP (Chondral Lesions And Meniscus Procedures) Trial is to determine whether there is a difference in knee pain between patients undergoing debridement versus observation of chondral lesions encountered during arthroscopic meniscectomy. This paper describes the rationale and study design for the ChAMP Trial.

Methods/Design

The ChAMP Trial is a randomized controlled trial of patients aged 30 and older undergoing partial meniscectomy and randomly allocated to debridement (CL-Deb, N = 98) or observation (CL-Obs, N = 92) of chondral lesions identified during surgery and deemed to be significant (Outerbridge Grade II-IV). Patients and data collectors were unaware of treatment allocation until completion of the study. Patients with surgically insignificant (Outerbridge Grade I) chondral lesions or no chondral lesions were included as a third non-randomized comparison group (NoCL, N = 76). The primary outcome is the difference in knee pain assessed by WOMAC (Western Ontario and McMaster Universities Arthritis Index) between the CL-Deb and CL-Obs groups at 1-year after surgery. Secondary outcomes include 1-year differences in additional measures of knee pain, function, symptoms, activity, and quality of life assessed by the WOMAC, KOOS (Knee Injury and Osteoarthritis Outcome Score), visual analog pain scale, and physical exam; as well as general health assessed with the SF-36 (Short-form Health Survey). Increased intraoperative costs associated with the addition of chondral debridement will also be assessed.

Discussion

This study will add to the scant literature regarding management of chondral lesions in patients undergoing meniscectomy and might provide treatment guidance for clinicians and their patients.