NCT03434600

Comparison of Oxford UKA and Sigma UKA With RSA.

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Regional Hospital Holstebro · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Knee Osteoarthritis
• Knee Replacement
• RSA

Interventions

Type	Name	Description
OTHER	Oxford UKA vs Sigma UKA

Timeline

• Start date: 2014-01-01
• Primary completion: 2017-11-01
• First posted: 2018-02-15
• Last updated: 2019-05-20