To assess non inferiority of a Multi Radius design (ACS® unicondylar) compared to a Single Radius design Unicondylar knee implant (Oxford) on clinical outcome using the Oxford Knee Score.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
• 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.
Background summary
In the last decades unicondylar knee arthroplasty has become widely accepted as
a valid option in the treatment for unicondylar osteoarthritis. Over these
decades several design options are altered and the best documented is the
Oxford® unicondylar design which has a mobile bearing and single radius design.
In Total knee arthroplasty the multi radius design is proven as an excellent
solution. This study is designed to show the non-inferiority of the ACS®
unicondylar knee arthroplasty, which is a mobile bearing with a multi radius
design, compared to a Single Radius design Unicondylar knee implant (Oxford).
Study objective
To assess non inferiority of a Multi Radius design (ACS® unicondylar) compared
to a Single Radius design Unicondylar knee implant (Oxford) on clinical outcome
using the Oxford Knee Score.
Study design
The study design is a prospective patient blinded randomized controlled study
comparing a Single Radius design Unicondylar knee implant (Oxford) with a Multi
Radius design (ACS® unicondylar) in terms of clinical outcome.
Intervention
Unicondylar knee arthroplasty with either the Oxford® unicondylar knee
arthroplasty or the ACS ® unicondylar knee arthroplasty.
Study burden and risks
All patient will be seen at regular follow up intervals identical to the normal
unicondylar knee arthroplasty protocol. At these visits patients will be asked
to fill out a questionnaire.
All patients will be treated according to standard UKA protocol, with an
implant that is available on the market and has a CE marking. Bearing this in
mind we judge the study as safe.
Louwesweg 6
Amsterdam 1066EC
NL
Louwesweg 6
Amsterdam 1066EC
NL
Listed location countries
Age
Inclusion criteria
• Age > 18
• BMI < 40
• Medial Unicondylar symptomatic OA of a knee joint
• Able to provide informed consent
Exclusion criteria
• Co-morbidity influencing the outcome of the implant.
• Hypersensetivity to metals.
• Not being able to fill in the Dutch Questionnaires.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL50651.048.14 |
| OMON | NL-OMON29323 |