NCT02583113
Withdrawn
Not Applicable
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.
Medacta USA1 site in 1 countryFebruary 2016
ConditionsOsteoarthritis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteoarthritis
- Sponsor
- Medacta USA
- Locations
- 1
- Primary Endpoint
- To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must be able to read, understand and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF)
- •Ability to understand and provide written authorization for use and disclosure of personal health information
- •Subject who are able and willing to comply with the study protocol and follow-up visit
- •Must be 18 years or older to participate
- •Subjects must have a clinically documented osteoarthritis in both knees, single or multiple compartments
- •Subjects must have undergone a primary TKA and primary UKA in the contralateral knee
- •Must be a minimum 2 year (24 months) post-surgery on each knee
- •One or both TKA/UKA surgeries must have been performed by the Principal Investigator.
- •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
- •Subjects who underwent UKA with Patella Femoral Joint (PFJ) replacement on the same side.
- •Women who are pregnant
Outcomes
Primary Outcomes
To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)
Time Frame: Minimum 2 years post surgery
Asking patients "which is your better knee overall"
Secondary Outcomes
- Forgotten Joint Score (FJS)(Minimum of 2 years post-op)
- Knee Society Score (KSS) subjective measures(Minimum of 2 years post-op)
- Euro-Qual Health Related Quality of Life (EQ-5D)(Minimum of 2 years post-op)
- Return to work history(Minimum of 2 years post-op)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Minimum 2 years post-op)
- Knee Society Score (KSS) Objective measures(Minimum of 2 years post-op)
- Radiographic Analysis(Pre-operative and minimum of 2 years post-op)
- Demographics(Pre-operative and Minimum of 2 years post-op)
Study Sites (1)
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