NCT04709861

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
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Ankle Osteoarthritis

Timeline

• Start date: 2021-04-07
• Primary completion: 2024-03-16
• Completion: 2024-03-16
• First posted: 2021-01-14
• Last updated: 2024-04-24

Locations

1 site across 1 country: United States