Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:February 2016
End Date:December 30, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

A Retrospective, Consecutive Series, Single Surgeon Study Comparing Patient Satisfaction and Clinical Outcomes in Patients With Fixed Bearing Versus Mobile Bearing Unicompartmental Knee Arthroplasty

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.


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.
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