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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03434600

Enrollment

Registered

2018-02-15

Start date

2014-01-31

Completion date

Unknown

Last updated

2019-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis, Knee Replacement, RSA

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

Interventions

OTHEROxford UKA vs Sigma UKA

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Migration of prosthesis	2 years follow-up	RSA

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026