Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01931735
First received: August 23, 2013
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

Further study details as provided by Department of Veterans Affairs:

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

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01931735

Contacts
Contact: Nicholas J Giori, MD PhD (650) 493-5000 ext 64765 Nicholas.Giori@va.gov
Contact: Shannon N Edd, MS (864) 650-6564 snedd@stanford.edu

Locations
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    philip.tsao@va.gov   
Contact: Lawrence L Leung, MD    (650) 493-5000 ext 65742    Lawrence.Leung@va.gov   
Principal Investigator: Nicholas J. Giori, MD PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Nicholas J. Giori, MD PhD VA Palo Alto Health Care System, Palo Alto, CA
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01931735     History of Changes
Other Study ID Numbers: E0924-R, 1I01RX000924-01A2
Study First Received: August 23, 2013
Last Updated: July 2, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
menisci
tibial

ClinicalTrials.gov processed this record on September 22, 2014