The aim of this study is to test the safety and effectiveness of the Genus Unicompartmental knee prosthesis over a period of 10 years.
ID
Source
Brief title
Condition
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Implant survival rate keeping revision for any reason as an end point. Implant
survival rate will be elaborated emplying the Kaplan-Meier statistical system.
Secondary outcome
Cohort study
1. Patients oxford Knee Score
2. Knee Society Score
3. EuroQol Score
PROMS are being collected pre-op, 3 months, 6 months and annually after that.
For clinical assesment it will be done at 1, 3, 5, 7 and 10 years
post-operatively. Data will also be entered in the Dutch LROI system
(landelijke register orthopedische implantaten)
X-rays will be checked looking for prosthesis alignment and sign of loosening
or wear.
Background summary
Knee replacement surgery (arthroplasty) involves replacing a damaged, worn or
diseased knee with an artificial joint (knee prosthesis). It is a routine
operation for knee pain most commonly caused by arthritis.
Study objective
The aim of this study is to test the safety and effectiveness of the Genus
Unicompartmental knee prosthesis over a period of 10 years.
Study design
Multicenter prospective clinical surveillance study
Intervention
Surgical intervention: people recieve a unicondylar knee prosthesis
Study burden and risks
Participating patiënts will undergo a similar treatment as other patients for a
uni-condylar knee arthroplasty.
Via Dell'Innovazione 9
Cormano (Milano) 20032
IT
Via Dell'Innovazione 9
Cormano (Milano) 20032
IT
Listed location countries
Age
Inclusion criteria
- A primary osteoarthritis of one compartment (Medial or Lateral).
- Patients must be between the age of 18 and 80 at the time of consent
- Listed for unicompartmental knee arthroplasty.
- Patients who are willing to give informed written consent
- Absence of any degenerative disease of a progressive nature (e.g.
Rheumatoid arthritis)
Exclusion criteria
Progressive local or systemic infection
- Muscular loss, neuromuscular disease or vascular deficiency of the
affected limb, making the operation unjustifiable
- Severe instability secondary to advance destruction of chondral
structures or loss of integrity of the medial, lateral or either cruciate
ligament
- Any patient who cannot or will not provide informed consent for
participation in the study
- Those whose prospects for a recovery to independent mobility would
be compromised by known coexistent, medical problems
- Patient whose BMI exceeds 45
- Any case not described in the inclusion criteria
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ISRCTN | ISRCTN14119313 |
| CCMO | NL57306.058.16 |