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.
NCT number | NCT03434600 |
Other study ID # | HolstebroH |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2014 |
Verified date | May 2019 |
Source | Regional Hospital Holstebro |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 61 |
Est. completion date | |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Regional Hospital Holstebro |
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 |
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