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TAR 2 Weeks vs 6 Weeks Post-Operative Weight-Bearing

Early 2 Weeks Versus Delayed 6 Weeks Post-Operative Weight-Bearing in Total Ankle Replacement

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04709861
Acronym
TAR
Enrollment
33
Registered
2021-01-14
Start date
2021-04-07
Completion date
2024-03-16
Last updated
2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Osteoarthritis

Brief 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. 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.

Interventions

None listed

Sponsors

University of Oklahoma
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
osseointegrationtime of surgery through 2 yearsa 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.

Secondary

MeasureTime frameDescription
stability of implanttime of surgery through 2 yearsradiological 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026