The ChAMP (Chondral Lesions And Meniscus Procedures) Trial
- Conditions
- ChondromalaciaMeniscal Tear
- Interventions
- Procedure: Arthroscopic debridement
- Registration Number
- NCT01527201
- Lead Sponsor
- State University of New York at Buffalo
- Brief Summary
The purpose of this randomized controlled trial is to determine the effectiveness of treating cartilage lesions found during knee arthroscopy.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
- Patients scheduled to undergo a meniscectomy
- Patients with chondral lesions found during meniscectomy
- Patients without chondral lesions are not eligible for randomization to one of the study arms, but will still be included in the study and observed after surgery
- Osteochondritis dissecans
- Large chondral flaps judged to be impending loose bodies
- Joint space loss of affected compartment greater than 50% compared to opposite side
- Visible osteophytes of the medial or lateral compartment
- Previous knee surgery on the affected side
- Previous major knee trauma
- History of inflammatory joint disease, gout, or chondrocalcinosis
- Presence of worker's compensation claim
- Patients undergoing meniscal repair
- Patients undergoing microfracture for contained grade IV chondral lesions
- Presence of significant ligamentous instability in the operative knee (i.e., complete acruciate ligament (ACL) or posterior cruciate ligament (PCL) tear, grade III medial or lateral side instability)
- Major neurologic deficit
- Serious medical illness with limited life expectancy or that poses high intraoperative risk
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Group Arthroscopic debridement Worn out cartilage will be surgically treated.
- Primary Outcome Measures
Name Time Method Self-reported knee pain 1-year after surgery
- Secondary Outcome Measures
Name Time Method Intra-operative costs associated with debridement (i.e., time and instruments needed to debride) Measured during surgery Surgeon records and documents the time and instruments needed for debridement.
Subjective measures and knee measurements 1-year after surgery 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.
Trial Locations
- Locations (1)
UB Orthopaedics and Sports Medicine
🇺🇸Buffalo, New York, United States