Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study

NCT ID: NCT02583113

Last Updated: 2023-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2026-12-01

Brief Summary

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To determine if there is a patient satisfaction preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) in patients with bilateral knee osteoarthritis who underwent a primary TKA one side and a primary UKA on the opposite side and are at a minimum of two years post-surgery. Patient reported outcomes and data with be analyzed along with all retrospective chart data.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Total and Unicompartment Knee Replacement

Total and Unicompartment Knee Replacement

Intervention Type DEVICE

Patients who have undergone a primary TKA on one side and primary UKA on the opposite side and are at a minimum of two years post-surgery.

Interventions

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Total and Unicompartment Knee Replacement

Patients who have undergone a primary TKA on one side and primary UKA on the opposite side and are at a minimum of two years post-surgery.

Intervention Type DEVICE

Other Intervention Names

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TKA UKA

Eligibility Criteria

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Inclusion Criteria

1. Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
2. Ability to understand and provide written authorization for use and disclosure of personal health information
3. Subject who are able and willing to comply with the study protocol and follow-up visit
4. Must be 18 years or older to participate
5. Subjects must have a clinically documented osteoarthritis in both knees, single or multiple compartments
6. Subjects must have undergone a primary TKA and primary UKA in the contralateral knee
7. Must be a minimum 2 year (24 months) post-surgery on each knee
8. One or both TKA/UKA surgeries must have been performed by the Principal Investigator.
9. Subjects must be able to return for the follow-up appointment, and have the mental capacity to cooperate with PRO's, questionnaires, physical exam and radiographs

Exclusion Criteria

1. Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side.
2. Women who are pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medacta USA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mukesh Ahuja, MBBS, MS

Role: STUDY_DIRECTOR

Medacta USA, Inc

Locations

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Tri County Orthopeadic Center

Leesburg, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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UNI 001

Identifier Type: -

Identifier Source: org_study_id

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