NCT01527201

The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Meniscal Tear
• Chondromalacia

Interventions

Type	Name	Description
PROCEDURE	Arthroscopic debridement	Surgeon will debride, or remove, worn out cartilage.

Timeline

• Start date: 2012-01-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2012-02-06
• Last updated: 2021-04-15

Locations

1 site across 1 country: United States