Defect of Articular CartilageNCT02542566
Protected Versus Early Weight Bearing Post Microfracture Surgery
A study testing Physiotherapy rehabilitation in people with Defect of Articular Cartilage, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial summary
To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Defect of Articular Cartilage
- What is being tested?
- Physiotherapy rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2015to 1 Jul 2016
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Aged 16-60 years. Mechanically stable knee joint at outpatient examination. MRI confirmed grade 3 or 4 non-kissing cartilage defect within the knee. Able to fully understand the process and study and give informed consent to participate.
- Able to comply with the physiotherapy rehabilitation and follow up process.
Who cannot join
- Kissing cartilage defects. Defects deemed too large to undergo microfracture on MRI scan. Clinically unstable knee joint. Patients unable to consent to participation. Under 16 years of age or over 60 years of age. Patients likely to drop out of physiotherapy rehabilitation and study follow up.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS FT
Oswestry, Shropshire, SY10 7AG
About this study
Official title: Randomised Control Trial Comparing Conservative Rehabilitation and Protected Weight Bearing Versus Accelerated Rehabilitation and Early Weight Bearing Post Microfracture Knee Surgery.
To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.
Read the detailed description
To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.
Current practice in most units is to protect patients from weight bearing prior to entering a conservative physiotherapy rehabilitation program following microfracture surgery of the knee. At our unit we believe that protecting patients from weight bearing post microfracture surgery makes no difference to their outcome and only leads to a longer rehabilitation time and a delayed return to work and sports. Therefore we want to randomise patients who require microfracture surgery of the knee for cartilage defects into 2 post operative rehabilitation groups. One group will be able to weight bear early and will undergo an accelerated rehabilitation program whilst the other will be protected from weight bearing and will undergo a more conservative rehabilitation program. We will then follow patients up over a year and compare outcome data collected at 6 weeks, 3 months, 6 months and 1 year post operatively to see if there was any difference in outcomes between the 2 groups. As secondary outcomes we will also compare the patients in the two groups to see if there is a difference in time taken to return to work and sporting activities
- Conditions
- Defect of Articular Cartilage
- Being tested
- Physiotherapy rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy rehabilitationProcedure or surgery
Physiotherapy rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| early weight bearing | Active comparator | early weight bearing and accelerated physiotherapy rehabilitation Receives: Procedure: Physiotherapy rehabilitation |
| protected weight bearing | Active comparator | protected weight bearing and conservative physiotherapy rehabilitation. Receives: Procedure: Physiotherapy rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Tegner/Lysholm score from questionnaires.
Measured: 12 months
Secondary outcomes (2)
Time to return to work.
Measured: 12 months
Time to return to sporting activities
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start21 Jan 2015
- Primary completion1 Jul 2016
- Study completion1 Jul 2016
Why it stopped: Study was stopped prematurely due to the lack of eligible participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defect of Articular CartilageStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Peter Gallacher, Surgeon, Study director, NHS Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542566
- Sponsor's protocol ID
- version 4 28/08/2014
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial Comparing Conservative Rehabilitation and Protected Weight Bearing Versus Accelerated Rehabilitation and Early Weight Bearing Post Microfracture Knee Surgery.
- ClinicalTrials.gov ID
- NCT02542566
- Acronym / sponsor ID
- version 4 28/08/2014
- Conditions
- Defect of Articular Cartilage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped prematurely due to the lack of eligible participants.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 1 Jul 2016 (actual)
- Study completion
- 1 Jul 2016 (actual)
- First posted
- 7 Sep 2015 (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.
To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.
Detailed description
To test using a randomised control trial, whether conservative rehabilitation and protected weight bearing versus early weight bearing and accelerated rehabilitation affects patient outcomes post microfracture surgery of the knee.
Current practice in most units is to protect patients from weight bearing prior to entering a conservative physiotherapy rehabilitation program following microfracture surgery of the knee. At our unit we believe that protecting patients from weight bearing post microfracture surgery makes no difference to their outcome and only leads to a longer rehabilitation time and a delayed return to work and sports. Therefore we want to randomise patients who require microfracture surgery of the knee for cartilage defects into 2 post operative rehabilitation groups. One group will be able to weight bear early and will undergo an accelerated rehabilitation program whilst the other will be protected from weight bearing and will undergo a more conservative rehabilitation program. We will then follow patients up over a year and compare outcome data collected at 6 weeks, 3 months, 6 months and 1 year post operatively to see if there was any difference in outcomes between the 2 groups. As secondary outcomes we will also compare the patients in the two groups to see if there is a difference in time taken to return to work and sporting activities
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| early weight bearing | Active comparator | Procedure: Physiotherapy rehabilitationearly weight bearing and accelerated physiotherapy rehabilitation |
| protected weight bearing | Active comparator | Procedure: Physiotherapy rehabilitationprotected weight bearing and conservative physiotherapy rehabilitation. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Aged 16-60 years. Mechanically stable knee joint at outpatient examination. MRI confirmed grade 3 or 4 non-kissing cartilage defect within the knee. Able to fully understand the process and study and give informed consent to participate.
- Able to comply with the physiotherapy rehabilitation and follow up process.
Key exclusion criteria (1 listed)
- Kissing cartilage defects. Defects deemed too large to undergo microfracture on MRI scan. Clinically unstable knee joint. Patients unable to consent to participation. Under 16 years of age or over 60 years of age. Patients likely to drop out of physiotherapy rehabilitation and study follow up.
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 |
|---|---|---|
| Physiotherapy rehabilitationPhysiotherapy rehabilitation | Procedure or surgery | early weight bearing, protected weight bearing |
Primary outcome
Modified Tegner/Lysholm score from questionnaires.
Time frame: 12 months
2 secondary outcomes
Time to return to work.
Time frame: 12 months
Time to return to sporting activities
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Study was stopped prematurely due to the lack of eligible participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
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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.
Peter Gallacher, Surgeon study director
NHS Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy rehabilitation in people with Defect of Articular Cartilage, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS 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 1 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: stopped early, as of the sponsor's last update on 6 Apr 2017. 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 stopped early (reason given: Study was stopped prematurely due to the lack of eligible participants.). Results are not available in the source record.
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?
Modified Tegner/Lysholm score from questionnaires. (time frame: 12 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 6 Apr 2017.