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Arthroscopic Debridement for Chondral Lesions in the Knee

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by State University of New York at Buffalo
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01527201
First received: January 19, 2012
Last updated: September 12, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention
Meniscal Tear
Chondromalacia
Procedure: Arthroscopic debridement

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Self-reported knee pain [ Time Frame: 1-year after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Intra-operative costs associated with debridement (i.e., time and instruments needed to debride) [ Time Frame: Measured during surgery ] [ Designated as safety issue: No ]
    Surgeon records and documents the time and instruments needed for debridement.

  • Subjective measures and knee measurements [ Time Frame: 1-year after surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 190
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01527201

Contacts
Contact: Leslie Bisson, MD 716-204-3255
Contact: Melissa Kluczynski, MS 716-829-2561 mk67@buffalo.edu

Locations
United States, New York
UB Orthopaedics and Sports Medicine Recruiting
Buffalo, New York, United States, 14214
Principal Investigator: Leslie Bisson, MD         
Sub-Investigator: Geoffrey Bernas, MD         
Sub-Investigator: Marc Fineberg, MD         
Sub-Investigator: John Marzo, MD         
Sub-Investigator: Michael Rauh, MD         
Sub-Investigator: Robert Smolinski, MD         
Sub-Investigator: William Wind, MD         
Sponsors and Collaborators
State University of New York at Buffalo
  More Information

Publications:
Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01527201     History of Changes
Other Study ID Numbers: OPS1561011B
Study First Received: January 19, 2012
Last Updated: September 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
Arthroscopy
Debridement

ClinicalTrials.gov processed this record on November 20, 2014