Clinical trial NCT01527201: The ChAMP (Chondral Lesions And Meniscus Procedures) Trial
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniscal Tear
Chondromalacia
Keywords: Arthroscopy
Debridement
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 190
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported knee pain
timeFrame: 1-year after surgery
Secondary outcomes:
measure: Intra-operative costs associated with debridement (i.e., time and instruments needed to debride)
timeFrame: Measured during surgery
measure: Subjective measures and knee measurements
timeFrame: 1-year after surgery
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: UB Orthopaedics and Sports Medicine
state: New York
Study officials:
affiliation: State University of New York at Buffalo
name: Leslie Bisson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirkley A, Birmingham TB, Litchfield RB, Giffin JR, Willits KR, Wong CJ, Feagan BG, Donner A, Griffin SH, D'Ascanio LM, Pope JE, Fowler PJ. A randomized trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2008 Sep 11;359(11):1097-107. doi: 10.1056/NEJMoa0708333.
citation: Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002 Jul 11;347(2):81-8. doi: 10.1056/NEJMoa013259.