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

NCT04709861 | Terminated DMC

• 1 other identifier: 12704
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankle Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• stability of implant

  time of surgery through 2 years

Study Arms (2)

Retrospective 6 week Weight-Bearing

Delayed weight-bearing 6 weeks after total ankle replacement

Prospective 2 week Weight-Bearing

Early weight-bearing 2 weeks after total ankle replacement

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

35

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OUPhysicians

Oklahoma City, Oklahoma, 73104, United States

Location

Study Officials

• Amgaad Haleem, MD

  University of Oklahoma, Orthopedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 14, 2021
• Study Start: April 7, 2021
• Primary Completion: March 16, 2024
• Study Completion: March 16, 2024
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)