to analyse patient functional outcome (objectively and subjectively), radiographic results of both acetabular and femoral component, and rate of complications after revision of the acetabular component
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
functional outcome using scoring systems (Oxford Hip score, HOOS, VAS for pain/
satisfaction and experienced recovery)
Secondary outcome
radiographic results: osteolysis using Gruen (femoral stem) and DeLee-Charnley
(acetabular component) zonal system, amount of migration and collapse of both
components
complications: secondary revisions, infections, dislocations and death
Background summary
in the past the uncemented Omnifit (Osteonics Corporation, Allendale, New
Jersey, USA) total hip prosthesis has been used in treating osteoarthritis of
the hip. Previously, unsatisfactory results with the uncemented acetabular
component have been reported. Frequently, the acetabular component had to be
revised due to loosening from polyethylene disease and severe osteolysis.
However, the femoral component was revised less frequently. To date, only few
studies have been published on the survival of the Omnifit total hip prosthesis
with a maximum follow-up of 20 years and a reported excellent survivorship of
the femoral stem of nearly 100%. However, functional outcome in patients who
had a revision operation has not been described
Study objective
to analyse patient functional outcome (objectively and subjectively),
radiographic results of both acetabular and femoral component, and rate of
complications after revision of the acetabular component
Study design
follow-up study
Study burden and risks
although an extra radiographic exam will be performed to analyse radiographic
results no extra risks are to be expected as those standard for regular
follow-up in the outpatient clinic
Hilvarenbeekseweg 60
5022 GC Tilburg
Nederland
Hilvarenbeekseweg 60
5022 GC Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
Patients who had a revision operation for loosening of the acetabular component of the uncemented hydroxy-apatite coated Omnifit total hip prosthesis
Exclusion criteria
-
Design
Recruitment
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 | NL27102.008.09 |