Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2014-01-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Oxford
Patients receiving an Oxford UKA, which is the standard treatment for patients with medial osteoarthritis of the knee at our department.
Oxford UKA vs Sigma UKA
Sigma
Patients receiving a Sigma UKA, which is the experimental treatment.
Oxford UKA vs Sigma UKA
Interventions
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Oxford UKA vs Sigma UKA
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Regional Hospital Holstebro
OTHER
Responsible Party
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Daan Koppens
MD
Principal Investigators
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Daan Koppens
Role: PRINCIPAL_INVESTIGATOR
Hospital Unit Vest
Other Identifiers
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HolstebroH
Identifier Type: -
Identifier Source: org_study_id
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