The ChAMP (Chondral Lesions And Meniscus Procedures) Trial
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Design of a Randomized Controlled Trial Examining the Effects of Arthroscopic Debridement on Chondral Lesions in Patients Undergoing Partial Meniscectomy: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial|
- Self-reported knee pain [ Time Frame: 1-year after surgery ] [ Designated as safety issue: No ]
- Intra-operative costs associated with debridement (i.e., time and instruments needed to debride) [ Time Frame: Measured during surgery ] [ Designated as safety issue: No ]Surgeon records and documents the time and instruments needed for debridement.
- Subjective measures and knee measurements [ Time Frame: 1-year after surgery ] [ Designated as safety issue: No ]Subjective knee and general health scores will be assessed. Also, knee measurements including range of motion, presence of effusion, and quadriceps circumference will be assessed.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment Group
Worn out cartilage will be surgically treated.
Procedure: Arthroscopic debridement
Surgeon will debride, or remove, worn out cartilage.
Other Name: Chondroplasty
No Intervention: Control Group
Worn out cartilage will be observed, but will not be treated surgically.
Normal wear-and-tear on the knee can cause tissue, or cartilage, in the knee to soften over time forming chondral lesions. Worn out cartilage is often found during knee surgery for other conditions. Typically, surgeons will remove any worn out cartilage that is found using a procedure called debridement. However, the investigators do not know if surgically treating the worn out cartilage is better than leaving the tissue untreated, so it is necessary to compare the two. Patients who are found to have worn out cartilage during arthroscopy, will be randomly assigned to either receive treatment (debridement) or non-treatment (observation) of their cartilage. Patients without worn out cartilage will also be included in this study and observed postoperatively.
The primary objective of this study is to examine the effects of treatment of worn out cartilage (versus non-treatment of worn out cartilage and versus patients without worn out cartilage), on self-reported knee pain following arthroscopic meniscectomy using a double-blinded randomized controlled trial design. Secondary objectives of this study include examining the effects of treating worn out cartilage on other outcomes (subjective knee and general health scores and knee measurements including range of motion, presence of effusion and quadriceps circumference) and also to calculate the intra-operative costs associated with treatment, including the amount of time and instruments needed for debridement.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527201
|United States, New York|
|UB Orthopaedics and Sports Medicine|
|Buffalo, New York, United States, 14214|
|Principal Investigator:||Leslie Bisson, MD||State University of New York at Buffalo|