DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise

NCT ID: NCT02113280

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2018-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiotherapy

Physiotherapy

Group Type: ACTIVE_COMPARATOR

Physiotherapy

Intervention Type: PROCEDURE

Outpatient standardised physiotherapy regime with focus on exercise therapy

Arthroscopy

Arthroscopy

Group Type: EXPERIMENTAL

Arthroscopy

Intervention Type: PROCEDURE

Patients to receive knee arthroscopy and meniscal debridement

Interventions

Arthroscopy

Patients to receive knee arthroscopy and meniscal debridement

Intervention Type: PROCEDURE

Physiotherapy

Outpatient standardised physiotherapy regime with focus on exercise therapy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northumbria Healthcare NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Sarah Johnson-Lynn

Specialty Registrar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

North Tyneside General Hospital

North Shields, Tyne and Wear, United Kingdom

Countries

United Kingdom

Other Identifiers

NUTH-DJK-2013

Identifier Type: -

Identifier Source: org_study_id