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3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty

NCT03575975 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 9

Last updated 2021-05-28

Study results available
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Summary

Patients who have had a total ankle joint replacement surgery typically have limited movement in their ankles possibly due to the fact that commonly used ankle joint prosthetic devices only allow limited axes of motion.

This study will evaluate the ability of a Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis and INBONE 2 fixed-bearing prosthesis to restore triplanar motion in the tibiotalar (ankle) joint following a surgical arthroplasty (total joint replacement) procedure.

3D X-ray video motion analysis will be utilized to quantify range of motion measurements in two groups of ankle prosthesis users and a group of matched control participants.

Conditions

  • Ankle Arthroplasty
  • Prosthesis User
  • Joint Disease

Interventions

DEVICE

Total Ankle Replacement Prosthesis

Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.

Sponsors & Collaborators

  • Emory University

    collaborator OTHER

  • Stryker Orthopaedics

    collaborator INDUSTRY

  • Georgia Institute of Technology

    lead OTHER

Principal Investigators

  • Young-Hui Chang, PhD · Georgia Institute of Technology

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-30
Primary Completion
2020-04-16
Completion
2020-04-16
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03575975 on ClinicalTrials.gov