Clinical trial NCT02633085: Fixed Bearing Versus Mobile Bearing Patient Satisfaction and Clinical Outcome Study
Official title: A Retrospective, Consecutive Series, Single Surgeon Study Comparing Patient Satisfaction and Clinical Outcomes in Patients With Fixed Bearing Versus Mobile Bearing Unicompartmental Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Osteoarthritis
Keywords: Unicompartment Knee Replacement
Lead sponsor: Medacta USA
Sponsor class: INDUSTRY
First posted: 2015-12-17
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 Unicompartment Knee Replacement with a Fixed Bearing or Mobile Bearing prosthesis.

Brief summary: 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.


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 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.

Primary outcomes:
measure: To compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA
timeFrame: Minimum of two years post-surgery.
Secondary outcomes:
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Minimum of two years post-surgery.
measure: Forgotten Joint Score (FJS)
timeFrame: Minimum of two years post-surgery.
measure: Knee Society Score (KSS) subjective measures
timeFrame: Minimum of two years post-surgery.
measure: Euro-Qual Health related Quality of Life
timeFrame: Minimum of two years post-surgery.
measure: Return to Work History
timeFrame: Minimum of two years post-surgery.
measure: Radiographic Analysis
timeFrame: Minimum of two years post-surgery.
measure: Knee Society Score (KSS) Objective Measures
timeFrame: Minimum of two years post-surgery.
measure: Demographics
timeFrame: Minimum of two years post-surgery.
measure: Complications
timeFrame: Minimum of two years post-surgery.
Other outcomes:
measure: Sub-Study 1: Fixed Bearing Meta-analysis
timeFrame: Minimum of two years post-surgery.
measure: Sub Study 2: Prosthesis positing versus outcomes analysis
timeFrame: Minimum of two years post-surgery.
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: