The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

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

Detailed Description
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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.

Official Title
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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

Conditions
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Meniscal Tear, Chondromalacia

Intervention / Treatment
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* Procedure: Arthroscopic debridement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Worn out cartilage will be surgically treated. | Procedure: Arthroscopic debridement<br>* Surgeon will debride, or remove, worn out cartilage.<br>* Other names: Chondroplasty;|
| No Intervention: Control Group<br>Worn out cartilage will be observed, but will not be treated surgically. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported knee pain |  | 1-year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative costs associated with debridement (i.e., time and instruments needed to debride) | Surgeon records and documents the time and instruments needed for debridement. | Measured during surgery | 
| Subjective measures and knee measurements | 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. | 1-year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopy, Debridement