Establish the non-inferiority of the R3 acetabular system with a high survival rate at 10 years fu (at least 90%). Second objective is to establish good clinical results by means of (Harris Hip Score, Hoos, UCLA and radiologic failures (like…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival rate.
Secondary outcome
Harris Hip Score,
HOOS,
UCLA,
radiologic findings.
Background summary
The R3 acetabular system has the opportunity to choose whithin one system
between metal-on-metal, ceramic-ceramic and oxinium-cross-linked polyethylene
bearing combinations in total hip arthroplasty.
In the past metal on polyethylene wa the standard in total hip arthrplasty
surgery. But due to the problems of polyethylene wear (with loosening of
components as a result) new materials were developed (cross-linked
polyethylene).
At this moment patients who require a total hip arthroplasty are much more
active and are much younger.
The R3 system has been developed to fullfil this request for the young and
active patient. The R3 system is made of stronger materials (like ceramic),
less wear (cross-linked polyethylene) and suitable for the use of bigger heads
to provide luxations.
Besides these benefits, the locking mechanism of the R3 system has been changed
in a way the insert is more easy to put in, gives more stability and therefore
will initiate less wear.
The shell has a Stiktite coating which will provide a better possibility for
bone ongrowhts. And therefore more stability of the shell itself and less
migration.
Study objective
Establish the non-inferiority of the R3 acetabular system with a high survival
rate at 10 years fu (at least 90%).
Second objective is to establish good clinical results by means of (Harris Hip
Score, Hoos, UCLA and radiologic failures (like radiolucency) compared to other
primary total hip systems through literature.
Study design
prospective, multicenter, non-randomized, clinical outcome study.
Study burden and risks
Not applicable
Oberneuhofstrasse 10d
Baar 6340
CH
Oberneuhofstrasse 10d
Baar 6340
CH
Listed location countries
Age
Inclusion criteria
* Patient requires primary total hip arthroplasty due to non-inflammatory
degenerative joint disease (e.g. osteoarthritis, post-traumatic arthritis, avascular necrosis, dysplasia/DDH) or inflammatory joint disease (e.g., rheumatoid arthritis)
* Patient has met an acceptable preoperative medical clearance and is free from
or treated for cardiac, pulmonary, hematological, etc., conditions that would pose excessive operative risk
* The patient is willing to comply the follow-up schedule
Patient is 18-75 years old and he/she is skeletally mature
Exclusion criteria
* Patient has active infection or sepsis (treated or untreated)
* Patient is a prisoner or has an emotional or neurological condition that would
pre-empt their ability or unwillingness to participate in the study including mental illness, mental retardation, linguistic insufficiencies (i.e. immigrants), or drug/alcohol abuse.
* Patients with acute hip trauma (femoral neck fracture)
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 | NL24088.094.08 |