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Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01931735
Recruitment Status : Active, not recruiting
First Posted : August 29, 2013
Last Update Posted : September 14, 2017
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Arthroscopic meniscectomy is among the most commonly performed orthopedic surgical procedures in the VA system. There remains substantial uncertainty, however, regarding the short term benefits and the long term consequences of arthroscopic meniscectomy in patients with degenerative meniscus tears. Of major concern is the fact that degenerative meniscus tears are associated with osteoarthritis, and it is known that within two years of surgery, arthroscopic debridement for osteoarthritis is no better than placebo in relieving pain and restoring function. Longer term, meniscectomy has been shown to be associated with elevated risk of osteoarthritis development, raising the concern that meniscectomy can actually be harmful. The purpose of this study is to determine whether meniscectomy in the setting of a degenerative meniscus tear is of any clinical value. Determining this would either justify the expenses associated with arthroscopic meniscectomy on a large number of patients, or would identify an area of significant potential cost savings.

Condition or disease Intervention/treatment
Meniscus Tear Procedure: Meniscectomy Procedure: Arthroscopic Lavage

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears
Actual Study Start Date : October 1, 2013
Primary Completion Date : April 1, 2017
Estimated Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Meniscectomy
This group will have a partial meniscectomy
Procedure: Meniscectomy
Arthroscopic meniscectomy
Active Comparator: Lavage
This group will have arthroscopy and lavage
Procedure: Arthroscopic Lavage
Arthroscopic Lavage

Primary Outcome Measures :
  1. WOMAC score [ Time Frame: one year ]
    Western Ontario and McMaster Universities Arthritis Index is a standardized and validated survey used to evaluate the pain and function of patients with lower extremity arthritis.

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Veteran
  • Age between 45 and 70 years
  • Degenerative meniscus tear as seen on standard clinical MRI scan
  • Complaint of "mechanical symptoms" which would include popping, catching, or locking of the knee
  • Persistent symptoms for a minimum of three months despite conservative management
  • Patient is enrolled for arthroscopic meniscectomy
  • Subject agrees to the study follow-up schedule and signs informed consent.

Exclusion Criteria:

  • Radiographic osteoarthritis of the knee in any compartment greater than KL grade 2
  • Prior knee arthroscopy within two years of study enrollment
  • Unable to have an MRI scan
  • Does not agree to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931735

United States, California
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States, 94304-1290
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Nicholas J. Giori, MD PhD VA Palo Alto Health Care System, Palo Alto, CA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01931735     History of Changes
Other Study ID Numbers: E0924-R
1I01RX000924-01A2 ( U.S. NIH Grant/Contract )
First Posted: August 29, 2013    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development: