DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise

Knee Osteoarthritis Clinical Trial

— DEMAND  

Official title:

Randomised Controlled Trial Comparing Arthroscopy With Physiotherapy for Degenerative Meniscal Tears

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02113280
• Other study ID #: NUTH-DJK-2013
• Status: Withdrawn
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2018

Study information

• Verified date: September 2020
• Source: Northumbria Healthcare NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Meniscal Tears
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Arthroscopy
Patients to receive knee arthroscopy and meniscal debridement
• Physiotherapy
Outpatient standardised physiotherapy regime with focus on exercise therapy

Locations

Country	Name	City	State
United Kingdom	North Tyneside General Hospital	North Shields	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria Healthcare NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee injury and Osteoarthritis Outcome Score	Patient completed outcome measure	6weeks, 6 months, 12 months, 24 months
Secondary	SF12	Patient completed outcome measure	6 weeks, 6 months, 12 months, 24 months
Secondary	Pain visual analogue score	Patient completed outcome measure	6 weeks, 6 months, 12 months, 24 months