The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527201
Recruitment Status : Completed
First Posted : February 6, 2012
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):
State University of New York at Buffalo

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

Condition or disease Intervention/treatment Phase
Meniscal Tear Chondromalacia Procedure: Arthroscopic debridement Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Arm Intervention/treatment
Experimental: Treatment Group
Worn out cartilage will be surgically treated.
Procedure: Arthroscopic debridement
Surgeon will debride, or remove, worn out cartilage.
Other Name: Chondroplasty
No Intervention: Control Group
Worn out cartilage will be observed, but will not be treated surgically.

Primary Outcome Measures :
  1. Self-reported knee pain [ Time Frame: 1-year after surgery ]

Secondary Outcome Measures :
  1. Intra-operative costs associated with debridement (i.e., time and instruments needed to debride) [ Time Frame: Measured during surgery ]
    Surgeon records and documents the time and instruments needed for debridement.

  2. Subjective measures and knee measurements [ Time Frame: 1-year after surgery ]
    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.

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01527201

United States, New York
UB Orthopaedics and Sports Medicine
Buffalo, New York, United States, 14214
Sponsors and Collaborators
State University of New York at Buffalo
Principal Investigator: Leslie Bisson, MD State University of New York at Buffalo