The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients

NCT01264991

Degenerative Meniscus Tear

TERMINATED NA

Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions

NCT01803880

Chondral Lesion Plus Partial Medial Meniscectomy

TERMINATED NA

Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy

NCT00613535

Torn Meniscus

TERMINATED PHASE4

Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions

NCT03678948

Articular Cartilage Disorder of Knee

TERMINATED NA

Meniscus Surgery Registry

NCT04153643

Meniscus Lesion

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Meniscal Tear Chondromalacia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

Worn out cartilage will be surgically treated.

Group Type EXPERIMENTAL

Arthroscopic debridement

Intervention Type PROCEDURE

Surgeon will debride, or remove, worn out cartilage.

Control Group

Worn out cartilage will be observed, but will not be treated surgically.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Arthroscopic debridement

Surgeon will debride, or remove, worn out cartilage.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Chondroplasty

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No