Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective 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 1, 2019 |
A Retrospective Consecutive Series Patient Preference and Clinical Outcomes Study in Bilateral Knee Osteoarthritis Patients With Both Total Knee Arthroplasty and Unicompartment Knee Arthroplasty Prostheses.
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.
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.
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
We found this trial at
1
site
Leesburg, Florida 34748
Principal Investigator: J Mandume Kerina, MD
Phone: 352-326-8115
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