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

Ankle Osteoarthritis Clinical Trial

— TAR  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04709861
• Other study ID #: 12704
• Status: Terminated
• Start date: April 7, 2021
• Est. completion date: March 16, 2024

Study information

• Verified date: April 2024
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: March 16, 2024
• Est. primary completion date: March 16, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Osteoarthritis
• Osteoarthritis

Locations

Country	Name	City	State
United States	OUPhysicians	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	time of surgery through 2 years
Secondary	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.	time of surgery through 2 years