The primary objective is to determine the survival rate after two and five years in fixed bearing Oxford lateral PKR with an uncemented femoral component and present patient reported outcome measures (PROMS), range of motion, radiographic findings…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival of the prosthesis will be evaluated as the primary outcome. Any change
to the prosthesis after the initial surgery will be seen as a failure.
Secondary outcome
The secondary outcome parameters are PROMS (patient reported outcomes measures,
range of motion, radiographic findings and complication rates.
Background summary
Compared to medial partial knee replacement (PKR), lateral PKR is much less
often performed. The Oxford partial knee is one of the most used prosthesis in
PKR. A lot of developments in medial Oxford PKR were successfully integrated in
lateral Oxford PKR. However, in lateral PKR mobile bearings carry a higher risk
of dislocation. Therefore, surgeons now use more and more the fixed bearing
type consisting of a cemented fixed bearing lateral tibial component and an
uncemented femoral component. Especially on this combination data is lacking in
lateral PKR, while results in medial PKR are encouraging.
Study objective
The primary objective is to determine the survival rate after two and five
years in fixed bearing Oxford lateral PKR with an uncemented femoral component
and present patient reported outcome measures (PROMS), range of motion,
radiographic findings and complication rates.
Study design
A multicentre prospective cohort study
Study burden and risks
No additional risks account for patients in the current study, since all
procedures and data collection are already standard of care. Nevertheless,
patients who give informed consent will be encouraged to adhere to the
follow-up schedule and complete the digital patient reported outcome measures
in a timely matter.
Molengracht 21
Breda 4818CK
NL
Molengracht 21
Breda 4818CK
NL
Listed location countries
Age
Inclusion criteria
- Lateral compartment OA with bone on bone
- Primary OA
- Correctable intraarticular valgus deformity
- Full thickness cartilage on the medial side
- Understand the Dutch language
Exclusion criteria
- Ligaments not intact
- Tibial or femoral osteotomy
- Varus alignment
- Patellofemoral grooving or bone loss
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL78738.100.21 |