Osteoarthritis
Conditions
Keywords
Total Knee Replacement, Unicompartment Knee Replacement
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.
Interventions
DEVICETotal and Unicompartment Knee Replacement
Patients who have undergone a primary TKA on one side and primary UKA on the opposite side and are at a minimum of two years post-surgery.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate patient preference of Total Knee Arthroplasty (TKA) vs Unicompartmental Knee Arthroplasty (UKA) | Minimum 2 years post surgery | Asking patients which is your better knee overall |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Minimum 2 years post-op | Knee symptoms, pain, function, and QoL |
| Forgotten Joint Score (FJS) | Minimum of 2 years post-op | Knee function-patient's ability to forget the artificial joint in everyday life |
| Knee Society Score (KSS) subjective measures | Minimum of 2 years post-op | Patient Expectation and Satisfaction Sub-scores |
| Euro-Qual Health Related Quality of Life (EQ-5D) | Minimum of 2 years post-op | General health status |
| Radiographic Analysis | Pre-operative and minimum of 2 years post-op | 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 2 years post-op | — |
| Demographics | Pre-operative and Minimum of 2 years post-op | — |
| Return to work history | Minimum of 2 years post-op | Questionnaire for work history prior to surgery and after surgery |
Other
| Measure | Time frame |
|---|---|
| Complications will be recorded | Pre-operative and minimum 2 years post-operative |
Countries
United States
Outcome results
None listed