Osteochondritis Dissecans of Ankle and Joints of FootNCT01405664
the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for Osteochondral Defects of the Ankle
A study testing Weight-Bearing as Tolerated in people with Osteochondritis Dissecans of Ankle and Joints of Foot, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The rationale for this research study is to evaluate the effect on clinical outcomes of weight bearing as tolerated after forage surgery for the treatment of osteochondral defects of the ankle, thus potentially eliminating the need for a period of immobilisation or non-weight bearing after surgery. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteochondritis Dissecans of Ankle and Joints of Foot
- What is being tested?
- Weight-Bearing as Tolerated
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2011to 30 Sep 2023
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients aged 16-60 years
- No prior ankle surgery
- Able and willing to comply with follow-up
- Capable of provide informed consent
- Medically fit for surgery
- Lesions on preoperative CT Scan < 1.5cm
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- Symptomatic (ie:pain, restricted activities, inability to WB, decreased ROM)
- Single Isolated lesion
- Failure of conservative treatment (3 months of limited activities and/or weight bearing and/or immobilization)
Who cannot join
- Age less than 16 years or greater than 60 years
- Inflammatory arthritis
- Diffuse osteoarthritis of affected joint
- Associated fracture
- Prior ankle surgery for current injury (including arthroscopy)
- Unable to comply with follow-up
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- Unable to provide informed consent
- Bernt \& Hardy class IV (amenable to ORIF)
- Multiple osteochondral defects in one ankle or touching osteochondral lesions of tibia and talus
- Prior osteochondral defects of the affected ankle
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
Halifax, Nova Scotia, B3H3A7
About this study
Official title: A Randomized, Controlled Clinical Trial to Evaluate the Effect on Patient Outcomes of Weight Bearing Status After Forage of Osteochondral Defects of the Ankle
The rationale for this research study is to evaluate the effect on clinical outcomes of weight bearing as tolerated after forage surgery for the treatment of osteochondral defects of the ankle, thus potentially eliminating the need for a period of immobilisation or non-weight bearing after surgery.
The investigators hypothesize that their will be no difference in functional outcomes between weight bearing as tolerated as compared to non-weight bearing for six weeks after forage surgery for OCD of the ankle.
Read the detailed description
The hypothesis for advantage of the investigational post-operative therapy is based on:
Equivalent clinical outcomes to non-weight bearing; Similar radiographic findings on CT at follow-up visit between the two groups; reduced morbidity and disability to subjects through elimination of a period of non-weight bearing; reduction of cost to patients by eliminating need for adjuvant walking and mobility aids (crutches, taxis) and time off work.
- Being tested
- Weight-Bearing as Tolerated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-Bearing as ToleratedOther
Also called Weight-bearing status
WBAT immediately after surgery
| Study group | Role | What they receive |
|---|---|---|
| Non-Weight Bearing x 6 weeks | No intervention | Not described |
| Immediate Weight-Bearing as Tolerated | Experimental | Not described Receives: Other: Weight-Bearing as Tolerated |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle Osteoarthritis Scale
Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\disability
Measured: 12 months
Secondary outcomes (1)
CAT Scan
For assessment of cartilage healing
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study start1 Sep 2011
- Primary completion30 Sep 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteochondritis Dissecans of Ankle and Joints of FootStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Glazebrook, MD,FRCSC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01405664
- Sponsor's protocol ID
- WBOCD
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2011
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Clinical Trial to Evaluate the Effect on Patient Outcomes of Weight Bearing Status After Forage of Osteochondral Defects of the Ankle
- ClinicalTrials.gov ID
- NCT01405664
- Acronym / sponsor ID
- WBOCD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 29 Jul 2011 (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.
The rationale for this research study is to evaluate the effect on clinical outcomes of weight bearing as tolerated after forage surgery for the treatment of osteochondral defects of the ankle, thus potentially eliminating the need for a period of immobilisation or non-weight bearing after surgery.
The investigators hypothesize that their will be no difference in functional outcomes between weight bearing as tolerated as compared to non-weight bearing for six weeks after forage surgery for OCD of the ankle.
Detailed description
The hypothesis for advantage of the investigational post-operative therapy is based on:
Equivalent clinical outcomes to non-weight bearing; Similar radiographic findings on CT at follow-up visit between the two groups; reduced morbidity and disability to subjects through elimination of a period of non-weight bearing; reduction of cost to patients by eliminating need for adjuvant walking and mobility aids (crutches, taxis) and time off work.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Weight Bearing x 6 weeks | No intervention | – |
| Immediate Weight-Bearing as Tolerated | Experimental | Other: Weight-Bearing as Tolerated |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Patients aged 16-60 years
- No prior ankle surgery
- Able and willing to comply with follow-up
- Capable of provide informed consent
- Medically fit for surgery
Key exclusion criteria (10 listed)
- Age less than 16 years or greater than 60 years
- Inflammatory arthritis
- Diffuse osteoarthritis of affected joint
- Associated fracture
- Prior ankle surgery for current injury (including arthroscopy)
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 |
|---|---|---|
| Weight-Bearing as ToleratedAlso: Weight-bearing statusWBAT immediately after surgery | Other | Immediate Weight-Bearing as Tolerated |
Primary outcome
Ankle Osteoarthritis Scale
Time frame: 12 months
Pain and disability outcomes assessed on scale of 1-100. The higher the score is more pain\disability
1 secondary outcome
CAT Scan
Time frame: 12months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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.
Mark Glazebrook, MD,FRCSC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weight-Bearing as Tolerated in people with Osteochondritis Dissecans of Ankle and Joints of Foot, run by Nova Scotia Health Authority at 1 site in Canada.
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 21 Aug 2024. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ankle Osteoarthritis Scale (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 21 Aug 2024.