Comparison of Oxford UKA and Sigma UKA With RSA.

Study Overview
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Brief Summary
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Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Finally, the functional outcome after surgery is compared between the two arthroplasties. Hypothesis: H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up. H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years. H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and leg extension power (LEP) postoperative. H4: BMD of the proximal tibia does not influence migration of the tibial component

Official Title
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Comparison of the Oxford Unicompartmental Knee Prosthesis With the Sigma High Performance Partial Knee Using Rontgen Stereophotogrammetric Analysis in Patients With Primary Medial Unicompartmental Knee Osteoarthritis.

Conditions
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Knee Osteoarthritis, Knee Replacement, RSA

Intervention / Treatment
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* Other: Oxford UKA vs Sigma UKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All eligable patients with medial osteoarthritis of the knee. Exclusion Criteria: - Inflammatory arthritis. Patients who are not able to participate in the fast-track surgery program. Patients with a contralateral knee arthroplasty. Patients who are unable to provide informed consent. Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy. Serious systemic disease (e.g.. hemiparesis and severe parkinsonism) On-going case involving work injury of the knee. Female patients with a wish of becoming pregnant in the study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxford<br>Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department. | Other: Oxford UKA vs Sigma UKA<br> <br> |
| Experimental: Sigma<br>Patients receiving a Sigma UKA, which is the experimental treatment. | Other: Oxford UKA vs Sigma UKA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Migration of prosthesis | RSA | 2 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density | DXA | 2 years follow-up | 
| Polyethylene wear | Weight-bearing RSA | 5 years follow-up |