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

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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Recruitment Status : Withdrawn (Failed funding application.)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

Tracking Information
First Submitted Date  ICMJE October 16, 2013
First Posted Date  ICMJE April 14, 2014
Last Update Posted Date September 10, 2020
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
Change in Knee injury and Osteoarthritis Outcome Score [ Time Frame: 6weeks, 6 months, 12 months, 24 months ]
Patient completed outcome measure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • SF12 [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
    Patient completed outcome measure
  • Pain visual analogue score [ Time Frame: 6 weeks, 6 months, 12 months, 24 months ]
    Patient completed outcome measure
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise
Official Title  ICMJE Randomised Controlled Trial Comparing Arthroscopy With Physiotherapy for Degenerative Meniscal Tears
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Meniscal Tears
  • Knee Osteoarthritis
Intervention  ICMJE
  • Procedure: Arthroscopy
    Patients to receive knee arthroscopy and meniscal debridement
  • Procedure: Physiotherapy
    Outpatient standardised physiotherapy regime with focus on exercise therapy
Study Arms  ICMJE
  • Active Comparator: Physiotherapy
    Physiotherapy
    Intervention: Procedure: Physiotherapy
  • Experimental: Arthroscopy
    Arthroscopy
    Intervention: Procedure: Arthroscopy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 8, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
200
Estimated Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02113280
Other Study ID Numbers  ICMJE NUTH-DJK-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sarah Johnson-Lynn, Northumbria Healthcare NHS Foundation Trust
Study Sponsor  ICMJE Northumbria Healthcare NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Northumbria Healthcare NHS Foundation Trust
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP