The purposes of this long-term mutli-center study are: - To compare the long-term (10-year) radiographic and clinical outcomes of new E-Poly* liner in primary total hip arthroplasty with the conventional ArcomXL® polyethylene liner.- To compare the…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Wear measurements with X rays and clinical results measured with
questionnaires
Secondary outcome
Survival
Background summary
The main causes for a revision of a hip prosthesis are loosening of the
acetabulum or wear of the liner. To reduce the loosening and wear rates, two
new materials have been developed. Regenerex* is a metal with a titanium porous
surface which induces early bone ingrowths and thereby inhibits osteolysis and
loosening. E-poly* is a polymer containing vitamin E as an anti-oxidant, which
makes it possible to have a higher long term wear resistance as conventional
polymers. Both materials have shown good laboratories results and are therefore
accepted on the US and European market. However, long term clinical studies are
lacking
Study objective
The purposes of this long-term mutli-center study are:
- To compare the long-term (10-year) radiographic and clinical outcomes of new
E-Poly* liner in primary total hip arthroplasty with the conventional ArcomXL®
polyethylene liner.
- To compare the long-term (10-year) radiographic and clinical outcomes of the
Regenerex Ringloc +* acetabular component having a titanium porous surface with
the conventional plasma sprayed acetabular coating.
Study design
Multi center, international study with 1000 patients divided into 4 groups;
1) E-Poly* liner in a titanium plasma sprayed RingLoc® shell,
2) ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell,
3) Regenerex Ringloc +* shell with E-Poly* liner
4) Regenerex Ringloc +* shell with ArcomXL® polyethylene liner.
Because all groups demand special surgical instruments, prosthesis and
techniques, each hospital is randomized into 1 group. Each group contains 5
hospitals placing 50 prosthesis each. The Scheper hospital in Emmen is
randomized in group 4.
Intervention
An uncemented total hip prosthesis with an Taperloc stem, Regenerex Ringloc +*
shell and ArcomXL® polyethylene liner
Study burden and risks
Risks associated with hip replacements. Seven outpatient visits with X-rays and
questionnaires (duration of 30 minutes), all of them are regular visits.
Toermalijnring 600
Dordrecht 3301DB
NL
Toermalijnring 600
Dordrecht 3301DB
NL
Listed location countries
Age
Inclusion criteria
1. Male or female
2. 20 to 75 years of age
3. Subjects requiring primary total hip replacement
4. Subjects with diagnosis of osteoarthritis, or traumatic arthritis
5. Subjects with the appropriate bone stock to accept an acetabular component with a 32mm inner diameter.
6. Subjects who demonstrate the ability to return for follow-up for the next ten years.
Exclusion criteria
1. Subjects with limited life span
2. Subjects with difficulty in comprehending study protocol for any reason.
3. Subjects with inflammatory disease, previous infection or those requiring revision hip surgery.
4. Subjects with avascular necrosis.
5. Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.
6. Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia
7. Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity.
8. Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.
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 |
|---|---|
| ClinicalTrials.gov | NCT00545285 |
| CCMO | NL21615.056.08 |