Clinical trial NCT02583113: Bilateral Total Knee Arthroplasty vs Unicompartment Arthroplasty Retrospective and Clinical Outcome Study
Official title: 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.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis
Keywords: Total Knee Replacement
Unicompartment Knee Replacement
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients that have undergone a Total Knee and Unicompartment knee replacement contralateral.

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.


Eligibility criteria: 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

Primary outcomes:
measure: To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA)
timeFrame: Minimum 2 years post surgery
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Minimum 2 years post-op
measure: Forgotten Joint Score (FJS)
timeFrame: Minimum of 2 years post-op
measure: Knee Society Score (KSS) subjective measures
timeFrame: Minimum of 2 years post-op
measure: Euro-Qual Health Related Quality of Life (EQ-5D)
timeFrame: Minimum of 2 years post-op
measure: Return to work history
timeFrame: Minimum of 2 years post-op
measure: Radiographic Analysis
timeFrame: Pre-operative and minimum of 2 years post-op
measure: Knee Society Score (KSS) Objective measures
timeFrame: Minimum of 2 years post-op
measure: Demographics
timeFrame: Pre-operative and Minimum of 2 years post-op
Other outcomes:
measure: Complications will be recorded
timeFrame: Pre-operative and minimum 2 years post-operative
Locations:
city: Leesburg
country: United States
facility: Tri County Orthopeadic Center
state: Florida
Study officials:
affiliation: Medacta USA, Inc
name: Mukesh Ahuja, MBBS, MS
role: STUDY_DIRECTOR
References: