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Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: August 23, 2013
Last updated: April 11, 2017
Last verified: April 2017
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 Intervention
Meniscus Tear
Procedure: Meniscectomy
Procedure: Arthroscopic Lavage

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 82
Actual Study Start Date: October 1, 2013
Estimated Study Completion Date: September 2017
Primary Completion Date: April 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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
  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 identifier: 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
  More Information

Responsible Party: VA Office of Research and Development Identifier: NCT01931735     History of Changes
Other Study ID Numbers: E0924-R
1I01RX000924-01A2 ( US NIH Grant/Contract Award Number )
Study First Received: August 23, 2013
Last Updated: April 11, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
tibial processed this record on May 25, 2017