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Patient Blinded Randomized Clinical Trial comparing two types of mobile bearing unicondylar knee replacement

Patient Blinded Randomized Clinical Trial comparing two types of mobile bearing unicondylar knee replacement - Uni-Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40703
Enrollment
236
Registered
2014-10-31
Start date
2015-09-21
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Osteoarthritis Worn knee

Interventions

Unicondylar knee arthroplasty with either the Oxford® unicondylar knee arthroplasty or the ACS ® unicondylar knee arthroplasty.

Sponsors

Slotervaartziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Age > 18 • BMI

Exclusion criteria

Exclusion criteria: • Co-morbidity influencing the outcome of the implant. • Hypersensetivity to metals. • Not being able to fill in the Dutch Questionnaires.

Design outcomes

Primary

MeasureTime frame
Our main study endpoint is the Oxford Knee Score. A knee specific questionnaire specifically designed to measure outcome in knee arthroplasty patients. This score was chosen since most Partial Knee studies use this outcome, therefore our study can be compared with the other Partial Knee papers.

Secondary

MeasureTime frame
• To compare the overall QoL in patients with a Single Radius design Unicondylar knee implant (Oxford Partial Knee ®) to patients with a Multi Radius design (ACS® unicondylar). The Quality of life will be measured by using standardized questionnaires being: NRS for pain, EQ5D and a KOOS-PS. • To monitor and compare the revisions (survival) rate of both groups. All revisions (septic and aseptic) and second surgery for other reasons will be included in the survival analysis. • Level of resection needed for implantation.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)