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.
1 other identifier
interventional
61
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable knee-osteoarthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 9, 2018
CompletedFirst Posted
Study publicly available on registry
February 15, 2018
CompletedMay 20, 2019
May 1, 2019
3.8 years
February 9, 2018
May 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Migration of prosthesis
RSA
2 years follow-up
Secondary Outcomes (2)
Bone mineral density
2 years follow-up
Polyethylene wear
5 years follow-up
Study Arms (2)
Oxford
ACTIVE COMPARATORPatients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department.
Sigma
EXPERIMENTALPatients receiving a Sigma UKA, which is the experimental treatment.
Interventions
Eligibility Criteria
You may qualify if:
- All eligable patients with medial osteoarthritis of the knee.
You may not qualify if:
- \- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daan Koppens
Hospital Unit Vest
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 9, 2018
First Posted
February 15, 2018
Study Start
January 1, 2014
Primary Completion
November 1, 2017
Last Updated
May 20, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share