Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study

NCT ID: NCT02633085

Last Updated: 2023-03-24

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WITHDRAWN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

2023-03-22

Brief Summary

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The purpose of this study is to determine if there is a patient satisfaction preference of Fixed Bearing versus Mobile Bearing Unicompartmental Knee Arthroplasty (UKA) in patients who are at a minimum two years post operative. Patient reported outcomes and expectations will be analyzed along with all retrospective chart data in patient with a Fixed Bearing or a Mobile Bearing UKA in one or both knees.

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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Fixed Bearing or Mobile Bearing UKA

Fixed Bearing or Mobile Bearing UKA

Intervention Type DEVICE

Fixed Bearing or Mobile Bearing UKA Patients who have undergone a primary Fixed Bearing or a Mobile Bearing UKA in either knee and are at a minimum 2 years post-op.

Interventions

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Fixed Bearing or Mobile Bearing UKA

Fixed Bearing or Mobile Bearing UKA Patients who have undergone a primary Fixed Bearing or a Mobile Bearing UKA in either knee and are at a minimum 2 years post-op.

Intervention Type DEVICE

Other Intervention Names

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Zimmer Unicompartmental High Flex Knee System or Oxford Mobile Bearing

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 a knee, single or multiple compartments,
6. Subjects must have undergone a FB UKA or MB UKA in one and or both knees. MB UKA or FB UKA patients revised to Total Knee Arthroplasty (TKA) are eligible to enroll.
7. Must be a minimum 2 year (24 months) post-surgery on the knee.
8. The UKA operation must have been performed by the 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 imaging studies.

Exclusion Criteria

1. Subjects with Bicompartmental UKA (i.e. medical or lateral UKA combined with Patello Femoral Joint (PFJ) (UKA)
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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#002 FB vs MB

Identifier Type: -

Identifier Source: org_study_id

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