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Total Knee Arthroplasty Guidance Systems Study

NCT02830997 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2022-07-20

No results posted yet for this study

Summary

In total knee replacement operations, the surgeon uses techniques and instruments to guide the operation and ensure that all parts of the prosthesis (the artificial knee surfaces) are placed into the correct position. There are many techniques a surgeon can use to achieve accuracy in the operation. This study will compare the Principal Investigator's present precision-guided technique and instrumentation methods with a newly developed technique that uses a computer-based stereotactic guidance system. The purposes of the study are: 1.) to learn whether the use of the different guidance systems results in differences of accuracy of the placement of the prosthesis; 2.) to compare the length of time it takes an experienced joint replacement specialist to complete the operation using the different guidance systems; 3.) to learn whether there are advantages of either system in terms of the function and recovery of patients over the first year after surgery; and, 4.) to provide the manufacturer of the stereotactic guidance system with feedback on the technical ease of use and workflow ease of the system which may be used for training and education purposes and/or for planning further refinements to the system. The study will enroll up to 150 patients from Athens Orthopedic Clinic over 2 to 3 years.

Conditions

  • Osteoarthritis, Knee
  • Arthroplasty, Replacement, Knee

Interventions

DEVICE

Stereotactic guidance system

Sponsors & Collaborators

  • Stryker Orthopaedics

    collaborator INDUSTRY

  • Ormonde M. Mahoney, MD

    lead OTHER

Principal Investigators

  • Ormonde M Mahoney, MD · Athens Orthopedic Clinic, P.A.

  • Tracy L Kinsey, MSPH · Athens Orthopedic Clinic, P.A.

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-12
Primary Completion
2018-02-06
Completion
2021-01-05
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 NCT02830997 on ClinicalTrials.gov