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.
BACKGROUND
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
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.


CONCLUSIONS
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.
University at Buffalo, The State University of New York, Buffalo, NY, United States. Electronic address: ljbisson@buffalo.edu.
Leslie J
LJ
Bisson
University at Buffalo, The State University of New York, Buffalo, NY, United States.
Melissa A
MA
Kluczynski
University at Buffalo, The State University of New York, Buffalo, NY, United States.
William M
WM
Wind
University at Buffalo, The State University of New York, Buffalo, NY, United States.
Marc S
MS
Fineberg
University at Buffalo, The State University of New York, Buffalo, NY, United States.
Geoffrey A
GA
Bernas
University at Buffalo, The State University of New York, Buffalo, NY, United States.
Michael A
MA
Rauh
University at Buffalo, The State University of New York, Buffalo, NY, United States.
John M
JM
Marzo
University at Buffalo, The State University of New York, Buffalo, NY, United States.
Robert J
RJ
Smolinski
D000328:Adult; D054544:Arthroplasty, Subchondral / Q000379:methods*; D003646:Debridement / Q000379:methods*; D005260:Female; D006801:Humans; D007719:Knee Joint / Q000601:surgery*; D008297:Male; D008592:Menisci, Tibial / Q000601:surgery; D008875:Middle Aged; D009864:Ontario; D010146:Pain; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D057832:Watchful Waiting / Q000379:methods*
Arthroscopy; Chondral lesion; Debridement; Meniscus tear; Randomized controlled trial