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.

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Knee Replacement; RSA
• Intervention / Treatment: Other: Oxford UKA vs Sigma UKA

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oxford; 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
Experimental: Sigma; Patients receiving a Sigma UKA, which is the experimental treatment.	Other: Oxford UKA vs Sigma UKA

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Regional Hospital Holstebro
• Investigators: Principal Investigator: Daan Koppens, Hospital Unit Vest

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: February 9, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): May 20, 2019
• Last Update Submitted That Met QC Criteria: May 16, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: HolstebroH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No