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

Primary Purpose

Degenerative Meniscal Tears, Knee Osteoarthritis

Status
Withdrawn
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Arthroscopy
Physiotherapy
Sponsored by
Northumbria Healthcare NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Meniscal Tears

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • North Tyneside General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Physiotherapy

Arthroscopy

Arm Description

Physiotherapy

Arthroscopy

Outcomes

Primary Outcome Measures

Change in Knee injury and Osteoarthritis Outcome Score
Patient completed outcome measure

Secondary Outcome Measures

SF12
Patient completed outcome measure
Pain visual analogue score
Patient completed outcome measure

Full Information

First Posted
October 16, 2013
Last Updated
September 8, 2020
Sponsor
Northumbria Healthcare NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT02113280
Brief Title
DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise
Acronym
DEMAND
Official Title
Randomised Controlled Trial Comparing Arthroscopy With Physiotherapy for Degenerative Meniscal Tears
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Failed funding application.
Study Start Date
December 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria Healthcare NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Meniscal Tears, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy
Arm Type
Active Comparator
Arm Description
Physiotherapy
Arm Title
Arthroscopy
Arm Type
Experimental
Arm Description
Arthroscopy
Intervention Type
Procedure
Intervention Name(s)
Arthroscopy
Intervention Description
Patients to receive knee arthroscopy and meniscal debridement
Intervention Type
Procedure
Intervention Name(s)
Physiotherapy
Intervention Description
Outpatient standardised physiotherapy regime with focus on exercise therapy
Primary Outcome Measure Information:
Title
Change in Knee injury and Osteoarthritis Outcome Score
Description
Patient completed outcome measure
Time Frame
6weeks, 6 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
SF12
Description
Patient completed outcome measure
Time Frame
6 weeks, 6 months, 12 months, 24 months
Title
Pain visual analogue score
Description
Patient completed outcome measure
Time Frame
6 weeks, 6 months, 12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
North Tyneside General Hospital
City
North Shields
State/Province
Tyne And Wear
ZIP/Postal Code
NE29 8NL
Country
United Kingdom

12. IPD Sharing Statement

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DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise

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