No registrations found.
ID
Source
Brief title
Health condition
total hip arthroplasty, osteoarthritis, RSA, BoneMaster, coating
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiographic analysis with roentgen stereophotogrammetry analysis focussing on stem migration, bone remodelling, implant ingrowth
Secondary outcome
- Harris Hip Score (HHS)
- HOOS
- SF-12
Background summary
Stability of an implant is achieved during surgery (primary stability) and will increase afterwards (secondary stability). Press-fit ensures primary stability of cement-less components. Due to the favourable biomimetic properties, nanotechnology BoneMaster® coating is expected to enhance faster ingrowth.
Study objective
We hypothesise that the Taperloc BoneMaster coated stem is equal or better than conventional porous coated or cemented stem focussing on implant ingrowth and bone remodelling.
Study design
- follow-up at 1 and 5 years
- measurements at 0, 6wks, 3mnths, 6 mnths, 1yr, 2yr and 5yr
Intervention
- BoneMaster I
Randomisation in placement of a conventional Taperloc stem or the Taperloc BoneMaster® coated stem
- BoneMaster II
Randomisation in placement of a conventional Taperloc stem or the Taperloc BoneMaster® coated stem or cemented Taperloc stem.
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
Inclusion criteria
1. Male and non-pregnant females
-BoneMaster I: ¡Ü 65 years
-BoneMaster II: 66-75 years
2. Patients with a QI < 40.
3. Requiring primary THR, suitable for the use of the Taperloc stem.
4. Diagnosed with osteoarthritis (OA) or avascular necrosis.
5. ASA classification score I-III.
Exclusion criteria
1. Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome is considered unsatisfactory or not good. (Patients with contra-lateral THA >6 months ago with good outcome (Harris Hip Score >85) can be included in the study).
2. Patients with a major surgical procedure during the 12 weeks before the study-related operation.
3. Dutch language not mastered.
4. Recent Myocardial infarct or CVA (<3 months).
5. ASA IV-V
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 |
|---|---|
| NTR-new | NL1498 |
| NTR-old | NTR1568 |
| Other | Haaglanden Medical Center : 08-062 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |