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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02113280
Recruitment Status : Withdrawn (Failed funding application.)
First Posted : April 14, 2014
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Sarah Johnson-Lynn, Northumbria Healthcare NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Degenerative Meniscal Tears Knee Osteoarthritis Procedure: Arthroscopy Procedure: Physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial Comparing Arthroscopy With Physiotherapy for Degenerative Meniscal Tears
Actual Study Start Date : December 2015
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis Tears

Arm Intervention/treatment
Active Comparator: Physiotherapy
Physiotherapy
Procedure: Physiotherapy
Outpatient standardised physiotherapy regime with focus on exercise therapy

Experimental: Arthroscopy
Arthroscopy
Procedure: Arthroscopy
Patients to receive knee arthroscopy and meniscal debridement




Primary Outcome Measures :
  1. Change in Knee injury and Osteoarthritis Outcome Score [ Time Frame: 6weeks, 6 months, 12 months, 24 months ]
    Patient completed outcome measure


Secondary Outcome Measures :
  1. SF12 [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
    Patient completed outcome measure

  2. Pain visual analogue score [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
    Patient completed outcome measure



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02113280


Locations
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United Kingdom
North Tyneside General Hospital
North Shields, Tyne And Wear, United Kingdom, NE29 8NL
Sponsors and Collaborators
Northumbria Healthcare NHS Foundation Trust
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Responsible Party: Sarah Johnson-Lynn, Specialty Registrar, Northumbria Healthcare NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02113280    
Other Study ID Numbers: NUTH-DJK-2013
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases