TerminatedNot Applicable

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

Stopped: PI left the institution before enrollment was completed

United States33 participantsStarted 2021-04-07

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

osseointegration

Timeframe: time of surgery through 2 years

Trial details

NCT IDNCT04709861

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-03-16

View on ClinicalTrials.gov More Ankle Osteoarthritis trials