Prove by means of RSA, that HA coating has an advangtage in stability of the uncemented SL-PLUS femoral component in primary total hip arthroplasty.
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Migration of femoral component
Secondary outcome
Wear of the polythylene insert of the acetabular component, radiolucent lines
around femoral component, Harris Hip Score and Womac score.
Background summary
Hydroxyapatite (HA) stimulates bone ongrowth in uncemented hip prostheses, and
therefore less radiolucent lines on standard x-rays. But whether or not early
migration (2-5 years postoperative) will be less at HA coated SL-PLUS femoral
components compared to standard SL-Plus femoral components still is an
unanswered question. Longterm clinical results of SL-PLUS femoral omponents
are excellent.
RSA is a reliable, frequently used methode to measure early migration (after 2
years) of the protheses in bone.
The objective of this study is to prove by means of RSA, that migration of the
HA coated SL-PLUS femoral component might be less compared to the migration of
the standard SL-PLUS femoral component.
A second objevctive of the RSA study is to measure polyethylene wear of the
acetabular insert, which has been implanted by using navigation to gain an
optimal position of the cup in the acetabulum. Within the same study group, a
controlled randomized study will be performed to investigate if there is any
difference in wear between standard polyethylene and cross linked polyethylene
inserts. During hipsimulation studies it appeared that cross linked
polyethylene generates less wear particles. A possible disadvantage might be a
decrease of visco-elasticity.
Study objective
Prove by means of RSA, that HA coating has an advangtage in stability of the
uncemented SL-PLUS femoral component in primary total hip arthroplasty.
Study design
Randomised, controlled, single blind, monocenter prospective study.
Intervention
Total hip arthroplasty
Study burden and risks
Besides the radiation and extra time for RSA measurements, there will be no
extra burden for the patient.
The radiation dose of those extra x-rays per patient during the first 2 years
will be 1.8 mSv (=6*0.3mSv). This is comparble with normal background
radiation in the Netherlands (2.0 mSv/year)
During the 5th year of the study, the extra radiation dose per patient will be
0.3mSv, much lower than the normal background radiation.
Goldkampstraat 3a
7722RN Dalfsen
NL
Goldkampstraat 3a
7722RN Dalfsen
NL
Listed location countries
Age
Inclusion criteria
patients with primary osteoarthritis, avascular necrosis, hip dysplasia and requiring arthroplasty
Age 60-75 (inclusive); patients given informed consent
(page 4)
Exclusion criteria
Patients with proximal femur fracture, infection or prior osteotomy of affected hip joint; patients under treatment with bisphosphonates for osteoporosis; diagnosed Charnley C; requiring cortison medication; with BMI>35; requiring revision arthroplasty;
patients who need bilateral total hip replacements can only participate for one hip.
(page 4)
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL23524.048.08 |
| OMON | NL-OMON20898 |