N/A
N=16
Prospective Trial of Arthroscopic Meniscectomy for Degenerative Meniscus Tears
Meniscus Tear
Bottom Line
View on ClinicalTrials.gov: NCT01931735 ↗Enrolled (actual)
16
Serious AEs
7.4%
Results posted
Oct 2018
Primary outcome: Primary: WOMET Score — 57.5; 99.4; 37.0; 63.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Randomized Meniscectomy (Procedure); Randomized Lavage (Procedure); Standard of Care Meniscectomy Pre-Amend (Procedure); Standard of Care Meniscectomy Post-Amend (Procedure)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY WOMET Score |
49.0; 99.6; 57.4 | — |
| PRIMARY WOMET Score |
49.0; 99.6; 57.4 | — |
| PRIMARY Gait Knee Adduction Moment |
-3.32; -5.40; -2.15 | — |
| PRIMARY Average Rotation During Stance |
12.5; 8.2; 8.9 | — |
| SECONDARY KOOS Pain Score |
38.9; 100; 36.8; 66.7 | — |
| SECONDARY KOOS Pain Score |
38.9; 100; 36.8; 66.7 | — |
| SECONDARY TNFa |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01931735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.