Comparison of Oxford UKA and Sigma UKA With RSA.

Knee Osteoarthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434600
• Other study ID #: HolstebroH
• Status: Completed
• Phase: N/A
• Start date: January 2014

Study information

• Verified date: May 2019
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Knee Replacement
• Osteoarthritis
• Osteoarthritis, Knee
• RSA

Intervention

Other:
• Oxford UKA vs Sigma UKA

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Migration of prosthesis	RSA	2 years follow-up
Secondary	Bone mineral density	DXA	2 years follow-up
Secondary	Polyethylene wear	Weight-bearing RSA	5 years follow-up