Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: August 23, 2013
Last updated: May 19, 2016
Last verified: May 2016
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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]
    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
Study Start Date: October 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: April 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
Genders Eligible for Study:   Both
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

Contact: Nicholas J Giori, MD PhD (650) 493-5000 ext 64765
Contact: Shannon N Edd, MS (864) 650-6564

United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Philip S Tsao, PhD    650-493-5000 ext 66339   
Contact: Lawrence L Leung, MD    (650) 493-5000 ext 65742   
Principal Investigator: Nicholas J. Giori, MD PhD         
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 
Study First Received: August 23, 2013
Last Updated: May 19, 2016
Health Authority: United States: Federal Government

Keywords provided by VA Office of Research and Development:
tibial processed this record on May 24, 2016