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

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ClinicalTrials.gov Identifier: NCT04709861
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : April 13, 2021
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Description
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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.

Condition or disease
Ankle Osteoarthritis

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early 2 Weeks Versus Delayed 6 Weeks Post-Operative Weight-Bearing in Total Ankle Replacement
Actual Study Start Date : April 7, 2021
Estimated Primary Completion Date : January 31, 2022
Estimated Study Completion Date : January 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. osseointegration [ Time Frame: time of surgery through 2 years ]
    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.


Secondary Outcome Measures :
  1. stability of implant [ Time Frame: time of surgery through 2 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
35
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04709861


Contacts
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Contact: Fahimida Khan, MD 405-271-4426 fahmida-khan@ouhsc.edu
Contact: Kathy D Edge 405-271-4426 kathy-edge@ouhsc.edu

Locations
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United States, Oklahoma
OUPhysicians Recruiting
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
University of Oklahoma
Investigators
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Principal Investigator: Amgaad Haleem, MD University of Oklahoma, Orthopedic Surgery
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT04709861    
Other Study ID Numbers: 12704
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Information will only be shared with the our own research team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases