WithdrawnNot Applicable

DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise

Stopped: Failed funding application.

United Kingdom0Started 2015-12

Plain-language 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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age over 45 years * Knee pain in the presence of a medial meniscal tear on MRI. Exclusion Criteria: * History of trauma to the knee or ipsilateral lower limb in the past 2 years * Inability to engage in postoperative rehabilitation * Lacking capacity to consent * Evidence of infection * Previous knee surgery other than arthroscopy (diagnostic or partial meniscectomy) Neurological disease * Inflammatory arthritis * Loose bodies * Ligament injuries causing symptomatic instability * Women who are pregnant * Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease. * Uncontrolled disease states, such as moderate/severe asthma, COPD or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids, or recurrent infections.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Knee injury and Osteoarthritis Outcome Score

Timeframe: 6weeks, 6 months, 12 months, 24 months

Trial details

NCT IDNCT02113280

SponsorNorthumbria Healthcare NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12

View on ClinicalTrials.gov More Degenerative Meniscal Tears trials