The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

State University of New York at Buffalo190 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

190

Conditions

Meniscal Tear Chondromalacia

Interventions

Arthroscopic debridementPROCEDURE

Surgeon will debride, or remove, worn out cartilage.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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

Locations (1)

UB Orthopaedics and Sports Medicine

Buffalo, New York, United States

Outcomes

Primary Outcomes

Self-reported knee pain

Time frame: 1-year after surgery

Secondary Outcomes

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.

Time frame: 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.

Time frame: 1-year after surgery

Data from ClinicalTrials.gov

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