DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise (DEMAND)

Randomised Controlled Trial Comparing Arthroscopy With Physiotherapy for Degenerative Meniscal Tears

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.

Study Overview

• Status: Withdrawn
• Conditions: Knee Osteoarthritis; Degenerative Meniscal Tears
• Intervention / Treatment: Procedure: Physiotherapy; Procedure: Arthroscopy

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Tyne And Wear
    • North Shields, Tyne And Wear, United Kingdom, NE29 8NL
      • North Tyneside General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Physiotherapy	Procedure: Physiotherapy; Outpatient standardised physiotherapy regime with focus on exercise therapy
EXPERIMENTAL: Arthroscopy	Procedure: Arthroscopy; Patients to receive knee arthroscopy and meniscal debridement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee injury and Osteoarthritis Outcome Score	Patient completed outcome measure	6weeks, 6 months, 12 months, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF12	Patient completed outcome measure	6 weeks, 6 months, 12 months, 24 months
Pain visual analogue score	Patient completed outcome measure	6 weeks, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: Northumbria Healthcare NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2015
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2018

Study Registration Dates

• First Submitted: October 16, 2013
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (ESTIMATE): April 14, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: NUTH-DJK-2013