MedTrace Logo

Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears

NCT01931735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2018-11-21

Study results available
· View outcomes & findings →

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.

Conditions

  • Meniscus Tear

Interventions

PROCEDURE

Randomized Meniscectomy

Arthroscopic meniscectomy

PROCEDURE

Randomized Lavage

Arthroscopic Lavage

PROCEDURE

Standard of Care Meniscectomy Pre-Amend

Arthroscopic meniscectomy

PROCEDURE

Standard of Care Meniscectomy Post-Amend

Arthroscopic meniscectomy

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Nicholas J. Giori, MD PhD · VA Palo Alto Health Care System, Palo Alto, CA

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-01
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01931735 on ClinicalTrials.gov