The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

University at Buffalo (UB)

Status

Completed

Conditions

Chondromalacia

Meniscal Tear

Treatments

Procedure: Arthroscopic debridement

Study type

Interventional

Funder types

Other

Identifiers

NCT01527201

OPS1561011B

Details and patient eligibility

About

The purpose of this randomized controlled trial is to determine the effectiveness of treating cartilage lesions found during knee arthroscopy.

Full 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.

Enrollment

190 patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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