DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise

NCT02113280 | Withdrawn DMC

• 1 other identifier: NUTH-DJK-2013
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Knee injury and Osteoarthritis Outcome Score

  Patient completed outcome measure

  6weeks, 6 months, 12 months, 24 months

Secondary Outcomes (2)

• SF12

  6 weeks, 6 months, 12 months, 24 months

• Pain visual analogue score

  6 weeks, 6 months, 12 months, 24 months

Study Arms (2)

Physiotherapy

ACTIVE COMPARATOR

Physiotherapy

Procedure: Physiotherapy

Arthroscopy

EXPERIMENTAL

Arthroscopy

Procedure: Arthroscopy

Interventions

Arthroscopy PROCEDURE

Patients to receive knee arthroscopy and meniscal debridement

Arthroscopy

Physiotherapy PROCEDURE

Outpatient standardised physiotherapy regime with focus on exercise therapy

Physiotherapy

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 45 years
• Knee pain in the presence of a medial meniscal tear on MRI.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northumbria Healthcare NHS Foundation Trust: lead

Study Sites (1)

North Tyneside General Hospital

North Shields, Tyne and Wear, NE29 8NL, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Arthroscopy; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialty Registrar

Study Record Dates

• First Submitted: October 16, 2013
• First Posted: April 14, 2014
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: September 10, 2020

Record last verified: 2020-09

Locations

GB (1)