Clinical Trial: Study of Viscosupplementation for the Treatment of Knee Pain After Menisectomy

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: The Use of Viscosupplementation for the Treatment of Patients With Persistent Non-mechanical Pain Status-post Partial Menisectomy

Brief Summary: The investigators' objective is to analyze a group of patients who have had a partial meniscectomy but continue to have knee pain after surgery with a double-blind, randomized prospective study comparing the use of Hylan G-F 20(single injection of a viscosupplementation) versus placebo injection. The investigators would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.

Detailed Summary: A great majority of patients who have a partial menisectomy for mechanical symptoms do well with full return of function without pain. There is a sub-group of patients who are found to have Grade II- III chondromalacia lesions (deemed arthritic) at the time of surgery that have persistent generalized "arthritic-type" pain despite relief of their mechanical symptoms. To date, there are no published studies analyzing if this treatment is better than no treatment in this group of patients. We would expect patients who receive the treatment (Hylan G-F 20) to have lower pain compared to the patients who were in the placebo group (had the needle injected into the knee but no medication or substance injected) since Hylan G-F 20 has been shown to decrease pain in arthritic patients.
Sponsor: Grant Jones

Current Primary Outcome: VAS pain scale [ Time Frame: 0, 2, 6, 12, 18, 26 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Knee injury and Osteoarthritis Outcome Score [ Time Frame: 0, 2, 6, 12, 18, 26 weeks ]
  • SF-36® Health Survey [ Time Frame: 0, 2, 6, 12, 18, 26 weeks ]
  • Physical Examination [ Time Frame: 0, 2, 6, 12, 18, 26 weeks ]


Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: September 2, 2009
Date Started: December 2009
Date Completion:
Last Updated: March 27, 2012
Last Verified: March 2012