Ankle ArthritisNCT00552136
Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
A study testing Ankle Arthroplasty and Ankle Arthrodesis in people with Ankle Arthritis, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
The purpose of this study is to see if the clinical outcome success rate of Total Ankle Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot arthrosis and arthritis after surgery compared to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Arthritis
- What is being tested?
- Ankle Arthroplasty and Ankle Arthrodesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2005to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eighteen (18) or older
- Known to have ankle arthritis for more than six (6) months
- Tried non operative treatment measures (eg. activity modification, physiotherapy, orthotics, bracing etc.) and have not improved
- Patient tests (questionnaires) show that ankle arthritis is severe
- Patient willing to take part in the study, including signing consent form after carefully reading it
Who cannot join
- Dead Bone in the Ankle
- Severe foot or Ankle Deformity
- Prior Ankle Fusion or Replacement
- Active or Prior Infection in the Ankle
- Obesity (greater than 250 lbs)
- Medical Conditions precluding safe surgery
- Nerve or Muscle disease
- Severe osteoporosis
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to see if the clinical outcome success rate of Total Ankle Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of complications and revision surgery is acceptable when compared to Ankle Arthrodesis over a period of 10 years.
- Conditions
- Ankle Arthritis
- Being tested
- Ankle Arthroplasty, Ankle Arthrodesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle ArthroplastyProcedure or surgery
Also called Replacement
Ankle ArthrodesisProcedure or surgery
Also called Fusion
Ankle fusion surgery
| Study group | Role | What they receive |
|---|---|---|
| Ankle Arthroplasty | Active comparator | Not described Receives: Procedure: Ankle Arthroplasty |
| Ankle Artrodeses | Active comparator | Not described Receives: Procedure: Ankle Arthrodesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
AAOS Foot and Ankle Questionnaire - includes SF-36
Measured: 10 years
AOFAS Ankle-Hindfoot Scale
Measured: 10 years
Ankle Osteoarthritis Scale
Measured: 10 years
Foot Function Index
Measured: 10 years
Radiographs
Measured: 10 years
Complications
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study start30 May 2005
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle ArthritisStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Orthopaedic Foot and Ankle Society, Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Mark Glazebrook, MD, Principal investigator, Capital District Health Authority, Halifax CanadaTim Daniels, MD, Principal investigator, St. Michael's Hospital (Toronto, Canada)Alistair Younger, MD, Principal investigator, British Columbia CanadaJohnny Lau, MD, Principal investigator, TorontoWestern Hospital, Toronto CanadaPeter Dryden, MD, Principal investigator, Victoria, British Columbia CanadaMurry Penner, MD, Principal investigator, British Columbia,CanadaKevin Wing, MD, Principal investigator, British Columbia, CanadaCraig Stone, MD, Principal investigator, Newfoundland, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552136
- Sponsor's protocol ID
- CDHA-MG-001
- Status last verified
- Aug 2024
- First submitted
- 30 Oct 2007
- Last updated
- 21 Aug 2024
- Results posted
- 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
- Canadian Orthopaedic Foot and Ankle Society Surgical Treatment of Ankle Arthritis Outcome Study
- ClinicalTrials.gov ID
- NCT00552136
- Acronym / sponsor ID
- CDHA-MG-001
- Conditions
- Ankle Arthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Canadian Orthopaedic Foot and Ankle Society, Johnson & Johnson
- Study start
- 30 May 2005 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 1 Nov 2007 (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 purpose of this study is to see if the clinical outcome success rate of Total Ankle Arthroplasty is similar to that of Ankle Arthrodesis over a period of 10 years. This will include looking at whether Total ankle arthroplasty results in a lower rate of hindfoot arthrosis and arthritis after surgery compared to ankle joint arthrodesis and if the rate of complications and revision surgery is acceptable when compared to Ankle Arthrodesis over a period of 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankle Arthroplasty | Active comparator | Procedure: Ankle Arthroplasty |
| Ankle Artrodeses | Active comparator | Procedure: Ankle Arthrodesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eighteen (18) or older
- Known to have ankle arthritis for more than six (6) months
- Tried non operative treatment measures (eg. activity modification, physiotherapy, orthotics, bracing etc.) and have not improved
- Patient tests (questionnaires) show that ankle arthritis is severe
- Patient willing to take part in the study, including signing consent form after carefully reading it
Key exclusion criteria (8 listed)
- Dead Bone in the Ankle
- Severe foot or Ankle Deformity
- Prior Ankle Fusion or Replacement
- Active or Prior Infection in the Ankle
- Obesity (greater than 250 lbs)
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 |
|---|---|---|
| Ankle ArthroplastyAlso: Replacement | Procedure or surgery | Ankle Arthroplasty |
| Ankle ArthrodesisAlso: FusionAnkle fusion surgery | Procedure or surgery | Ankle Artrodeses |
Primary outcome
AAOS Foot and Ankle Questionnaire - includes SF-36
Time frame: 10 years
AOFAS Ankle-Hindfoot Scale
Time frame: 10 years
Ankle Osteoarthritis Scale
Time frame: 10 years
Foot Function Index
Time frame: 10 years
Radiographs
Time frame: 10 years
Complications
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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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.
Mark Glazebrook, MD principal investigator
Capital District Health Authority, Halifax Canada
Tim Daniels, MD principal investigator
St. Michael's Hospital (Toronto, Canada)
Alistair Younger, MD principal investigator
British Columbia Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Arthroplasty and Ankle Arthrodesis in people with Ankle Arthritis, 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 5 inclusion and 8 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: under way, not looking for participants, 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?
This study is still under way. Results are not available in the source record yet.
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?
AAOS Foot and Ankle Questionnaire - includes SF-36 (time frame: 10 years). The study lists 6 primary outcomes in all. 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.