Comparison of Oxford UKA and Sigma UKA With RSA.

Not Applicable

Completed

• Conditions: RSA; Knee Osteoarthritis; Knee Replacement
• Interventions: Other: Oxford UKA vs Sigma UKA

• Registration Number: NCT03434600
• Lead Sponsor: Regional Hospital Holstebro

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2017-11
• Study First Submitted: 2018-02-09
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-15
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-16
• Last Update Posted: 2019-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sigma	Oxford UKA vs Sigma UKA	Patients receiving a Sigma UKA, which is the experimental treatment.
Oxford	Oxford UKA vs Sigma UKA	Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department.

Primary Outcome Measures

Name	Time	Method
Migration of prosthesis	2 years follow-up	RSA

Secondary Outcome Measures

Name	Time	Method
Bone mineral density	2 years follow-up	DXA
Polyethylene wear	5 years follow-up	Weight-bearing RSA