DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise
NCT02113280 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2020-09-10
Summary
Patients with wear and tear in their knees (osteoarthritis) are often referred to orthopaedic surgeons following a sudden worsening of pain and mechanical symptoms (grinding, locking, giving way) in their knee due to tears of their meniscal cartilages. These tears are described as degenerative as they are not usually caused by a single injury but rather accumulation of wear and tear. It is not clear from the current available evidence what the best treatment for these patients is. Their underlying arthritis is not bad enough to require joint replacement yet and they were usually managing well with minimal problems from their knee until experiencing the meniscal tear. However, some of their symptoms are likely to be due to the arthritis rather than just the tear. Current treatment for these patients is usually in the form of conservative treatment with physiotherapy and supervised exercise or using arthroscopy (key-hole surgery) to trim the damaged area of the meniscus. We know from previous research that most of these patients will improve over time to some extent but it is not clear whether a greater improvement can be expected following surgery and if so, whether this applies to all patients with this problem or not.
Our study is intended to compare the outcome of patients with proven degenerative meniscal tears imaged on MRI scans, when they are assigned to arthroscopy followed by supervised exercise or supervised exercise alone. They will be randomly assigned and the outcome will be assessed using patient-completed questionnaires (Knee Outcome Osteoarthritis and injury Score \[KOOS\], SF12, visual analogue score for pain) and whether the patients go on to require further surgery during the period of the trial. The patients will be assessed at baseline, at 6 weeks, 6 months, 12 months and 24 months.
Conditions
- Degenerative Meniscal Tears
- Knee Osteoarthritis
Interventions
- PROCEDURE
-
Arthroscopy
Patients to receive knee arthroscopy and meniscal debridement
- PROCEDURE
-
Physiotherapy
Outpatient standardised physiotherapy regime with focus on exercise therapy
Sponsors & Collaborators
-
Northumbria Healthcare NHS Foundation Trust
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-31
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- United Kingdom
Study Locations
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