TAR 2 Weeks vs 6 Weeks Post-Operative Weight-Bearing | NCT04709861

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

NCT04709861

Sponsor

University of Oklahoma

Status

Terminated

Last Update Posted

Apr 24, 2024Actual

Enrollment

33Actual

Phase

Not provided

Conditions

Ankle Osteoarthritis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left the institution before enrollment was completed

Expanded Access Info

Start Date

Apr 7, 2021Actual

Primary Completion Date

Mar 16, 2024Actual

Completion Date

Mar 16, 2024Actual

First Submitted Date

Dec 18, 2020

First Submission Date that Met QC Criteria

Jan 13, 2021

First Posted Date

Jan 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2024

Last Update Posted Date

Apr 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amgaad Haleem, MD	University of Oklahoma, Orthopedic Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OUPhysicians		Oklahoma City	Oklahoma	73104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Information will only be shared with the our own research team

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided