Degenerative Meniscal TearsDEMANDNCT02113280
DEMAND - DEgenerative Meniscal Tears - Arthroscopy vs. Dedicated Exercise
A study testing Arthroscopy and Physiotherapy in people with Degenerative Meniscal Tears and Knee Osteoarthritis, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Degenerative Meniscal Tears, Knee Osteoarthritis
- What is being tested?
- Arthroscopy and Physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 45 years
- Knee pain in the presence of a medial meniscal tear on MRI.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
North Tyneside General Hospital
North Shields, Tyne and Wear, NE29 8NL
About this study
Official title: 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.
- Conditions
- Degenerative Meniscal Tears, Knee Osteoarthritis
- Being tested
- Arthroscopy, Physiotherapy
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroscopyProcedure or surgery
Patients to receive knee arthroscopy and meniscal debridement
PhysiotherapyProcedure or surgery
Outpatient standardised physiotherapy regime with focus on exercise therapy
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Active comparator | Physiotherapy Receives: Procedure: Physiotherapy |
| Arthroscopy | Experimental | Arthroscopy Receives: Procedure: Arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knee injury and Osteoarthritis Outcome Score
Patient completed outcome measure
Measured: 6weeks, 6 months, 12 months, 24 months
Secondary outcomes (2)
SF12
Patient completed outcome measure
Measured: 6 weeks, 6 months, 12 months, 24 months
Pain visual analogue score
Patient completed outcome measure
Measured: 6 weeks, 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2014 (estimated)
- Study startDec 2015
- Primary completionDec 2018
- Study completionDec 2018 (estimated)
Why it stopped: Failed funding application.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Meniscal TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria Healthcare NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Johnson-Lynn, Northumbria Healthcare NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02113280
- Sponsor's protocol ID
- NUTH-DJK-2013
- Acronym
- DEMAND
- Status last verified
- Sep 2020
- First submitted
- 16 Oct 2013
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Controlled Trial Comparing Arthroscopy With Physiotherapy for Degenerative Meniscal Tears
- ClinicalTrials.gov ID
- NCT02113280
- Acronym / sponsor ID
- DEMAND / NUTH-DJK-2013
- Conditions
- Degenerative Meniscal Tears, Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failed funding application.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northumbria Healthcare NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (estimated)
- First posted
- 14 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Active comparator | Procedure: PhysiotherapyPhysiotherapy |
| Arthroscopy | Experimental | Procedure: ArthroscopyArthroscopy |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 45 years
- Knee pain in the presence of a medial meniscal tear on MRI.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArthroscopyPatients to receive knee arthroscopy and meniscal debridement | Procedure or surgery | Arthroscopy |
| PhysiotherapyOutpatient standardised physiotherapy regime with focus on exercise therapy | Procedure or surgery | Physiotherapy |
Primary outcome
Change in Knee injury and Osteoarthritis Outcome Score
Time frame: 6weeks, 6 months, 12 months, 24 months
Patient completed outcome measure
2 secondary outcomes
SF12
Time frame: 6 weeks, 6 months, 12 months, 24 months
Pain visual analogue score
Time frame: 6 weeks, 6 months, 12 months, 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopy and Physiotherapy in people with Degenerative Meniscal Tears and Knee Osteoarthritis, run by Northumbria Healthcare NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee injury and Osteoarthritis Outcome Score (time frame: 6weeks, 6 months, 12 months, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.