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

University of Oklahoma (OU)

Status: Terminated

Conditions: Ankle Osteoarthritis

Study type: Observational

Funder types: Other

Identifiers

NCT04709861

12704

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

33 participants in 2 patient groups

Retrospective 6 week Weight-Bearing

Description:

Delayed weight-bearing 6 weeks after total ankle replacement

Prospective 2 week Weight-Bearing

Description:

Early weight-bearing 2 weeks after total ankle replacement