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Completed

NCT Number: NCT01527201

The ChAMP (Chondral Lesions And Meniscus Procedures) Trial

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

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UB Orthopaedics and Sports Medicine

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopic Debridement

Procedure

Surgeon will debride, or remove, worn out cartilage.

Other names: Chondroplasty

Primary outcomes

  1. Self-reported knee pain

    Time frame: 1-year after surgery

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Feb 6, 2012
Registry last updated
Apr 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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