Ankle OsteoarthritisTARNCT04709861
TAR 2 Weeks vs 6 Weeks Post-Operative Weight-Bearing
An observational study of Ankle Osteoarthritis, run by University of Oklahoma at 1 site in United States.
Trial summary
The Investigators hypothesize that an early 2 week post-operative protocol will have no difference in the successful osseointegration and stability of the total ankle replacement as compared to a delayed 6 week post-operative protocol. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Osteoarthritis
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2021to 16 Mar 2024
- Phase
- Observational
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 35
Retrospective/Prospective Inclusion Criteria:
Patients who have had a total ankle replacement with the Principal Investigator from the initiation of his clinical practice from September 2015 to September 2020.
Had delayed weight-bearing. Patients whose age and gender match the retrospective delayed weight-bearing group.
Retrospective/Prospective Exclusion Criteria:
Patients who have had Total Ankle Replacement with subsequent development of suture wound infection.
Patients who have had Total Ankle Replacement with subsequent development of deep infection requiring revision.
Patient who have had Total Ankle Replacement with subsequent development of Peri-prosthetic fractures during surgery or post-op.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early 2 Weeks Versus Delayed 6 Weeks Post-Operative Weight-Bearing in Total Ankle Replacement
The Investigators hypothesize that an early 2 week post-operative protocol will have no difference in the successful osseointegration and stability of the total ankle replacement as compared to a delayed 6 week post-operative protocol. The importance of the research is to allow patients who receive a total ankle replacement to bear weight 4 weeks earlier than the current protocol with no negative effect on the osseointegration and stability of the ankle replacement.
Read the detailed description
The study will be conducted using two groups. The first group will be a retrospective review of charts of 35 patients who received a total ankle replacement porous prosthesis by an orthopedic surgeon at the University of Oklahoma Health Sciences Center. This group was received a delayed 6 week post-operative weight-bearing protocol.
The second group will be prospective and include patients who will receive the same total ankle replacement porous prosthesis but will be assigned to early 2 weeks post-operative weight-bearing protocol.The retrospective and prospective groups will be age and gender matched. A Wright Medical Infinity Total Ankle Replacement System will be used for both groups.
Both groups will be assessed at 1 year and 2 years post-operative. This assessment will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.
- Conditions
- Ankle Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective 6 week Weight-Bearing | Delayed weight-bearing 6 weeks after total ankle replacement | |
| Prospective 2 week Weight-Bearing | Early weight-bearing 2 weeks after total ankle replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
osseointegration
a Chi Square Test will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.
Measured: time of surgery through 2 years
Secondary outcomes (1)
stability of implant
radiological images assessment will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.
Measured: time of surgery through 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start7 Apr 2021
- Primary completion16 Mar 2024
- Study completion16 Mar 2024
Why it stopped: PI left the institution before enrollment was completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amgaad Haleem, MD, Principal investigator, University of Oklahoma, Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709861
- Sponsor's protocol ID
- 12704
- Acronym
- TAR
- Status last verified
- Apr 2024
- First submitted
- 18 Dec 2020
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Information will only be shared with the our own research team
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early 2 Weeks Versus Delayed 6 Weeks Post-Operative Weight-Bearing in Total Ankle Replacement
- ClinicalTrials.gov ID
- NCT04709861
- Acronym / sponsor ID
- TAR / 12704
- Conditions
- Ankle Osteoarthritis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left the institution before enrollment was completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 16 Mar 2024 (actual)
- Study completion
- 16 Mar 2024 (actual)
- First posted
- 14 Jan 2021 (actual)
- 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 Investigators hypothesize that an early 2 week post-operative protocol will have no difference in the successful osseointegration and stability of the total ankle replacement as compared to a delayed 6 week post-operative protocol. The importance of the research is to allow patients who receive a total ankle replacement to bear weight 4 weeks earlier than the current protocol with no negative effect on the osseointegration and stability of the ankle replacement.
Detailed description
The study will be conducted using two groups. The first group will be a retrospective review of charts of 35 patients who received a total ankle replacement porous prosthesis by an orthopedic surgeon at the University of Oklahoma Health Sciences Center. This group was received a delayed 6 week post-operative weight-bearing protocol.
The second group will be prospective and include patients who will receive the same total ankle replacement porous prosthesis but will be assigned to early 2 weeks post-operative weight-bearing protocol.The retrospective and prospective groups will be age and gender matched. A Wright Medical Infinity Total Ankle Replacement System will be used for both groups.
Both groups will be assessed at 1 year and 2 years post-operative. This assessment will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective 6 week Weight-Bearing | – | –Delayed weight-bearing 6 weeks after total ankle replacement |
| Prospective 2 week Weight-Bearing | – | –Early weight-bearing 2 weeks after total ankle replacement |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
osseointegration
Time frame: time of surgery through 2 years
a Chi Square Test will take place during the post-operative care period and will be conducted as part of their post-operative care by the operating physician.
1 secondary outcome
stability of implant
Time frame: time of surgery through 2 years
Results and safety
The study was stopped early (reason given: PI left the institution before enrollment was completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: No. Information will only be shared with the our own research team
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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.
Amgaad Haleem, MD principal investigator
University of Oklahoma, Orthopedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Osteoarthritis, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 24 Apr 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 United States. 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: PI left the institution before enrollment was completed). 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?
osseointegration (time frame: time of surgery through 2 years). 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 24 Apr 2024.