Osteoarthritis
Conditions
Keywords
Unicompartment Knee Replacement
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.
Interventions
DEVICEFixed Bearing or Mobile Bearing UKA
Fixed Bearing or Mobile Bearing UKA Patients who have undergone a primary Fixed Bearing or a Mobile Bearing UKA in either knee and are at a minimum 2 years post-op.
Sponsors
Medacta USA
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To compare patient satisfaction scores of the Unicompartmental Fixed Bearing (FB) UKA vs Unicompartmental Mobile Bearing (MB) UKA | Minimum of two years post-surgery. | Utilizing Knee Score Society survey sub-score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Minimum of two years post-surgery. | Knee symptoms, pain, function and Qol |
| Forgotten Joint Score (FJS) | Minimum of two years post-surgery. | Knee Function-patients ability to forget the artificial joint in everyday life |
| Knee Society Score (KSS) subjective measures | Minimum of two years post-surgery. | patient expectation and satisfaction sub-scores |
| Euro-Qual Health related Quality of Life | Minimum of two years post-surgery. | General Health Status |
| Return to Work History | Minimum of two years post-surgery. | Questionnaire for work history prior to surgery and after surgery |
| Demographics | Minimum of two years post-surgery. | — |
| Complications | Minimum of two years post-surgery. | Complications will be recorded |
| Radiographic Analysis | Minimum of two years post-surgery. | Radiographic analysis will include evaluation of component and limb alignment, evidence of component subsidence or migration, and the presence and progression of radiolucent lines between the prosthesis, bone and cement. |
| Knee Society Score (KSS) Objective Measures | Minimum of two years post-surgery. | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sub-Study 1: Fixed Bearing Meta-analysis | Minimum of two years post-surgery. | Full Knee Society Score (KSS) and Short Form Health Survey SF-12 |
| Sub Study 2: Prosthesis positing versus outcomes analysis | Minimum of two years post-surgery. | CT scan of Fixed Bearing patients for implant position |
Countries
United States
Outcome results
None listed