The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

Meniscal Tear Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527201
• Other study ID #: OPS1561011B
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: July 2016

Study information

• Verified date: April 2021
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Diseases
• Chondromalacia
• Meniscal Tear

Intervention

Procedure:
• Arthroscopic debridement
Surgeon will debride, or remove, worn out cartilage.

Locations

Country	Name	City	State
United States	UB Orthopaedics and Sports Medicine	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Erratum in: N Engl J Med. 2009 Nov 12;361(20):2004. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported knee pain		1-year after surgery
Secondary	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
Secondary	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