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

Contemporary Clinical Trials
Leslie J BissonRobert J Smolinski

Abstract

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. 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 ...Continue Reading

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Citations

Jul 20, 2019·The Cochrane Database of Systematic Reviews·Jonathan S PalmerAndrew J Price
Jul 16, 2021·Arthroscopy : the Journal of Arthroscopic & Related Surgery : Official Publication of the Arthroscopy Association of North America and the International Arthroscopy Association·Leslie J BissonJiwei Zhao

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