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.
ID
Bron
Verkorte titel
Aandoening
total hip arthroplasty, osteoarthritis, RSA, BoneMaster, coating
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Radiographic analysis with roentgen stereophotogrammetry analysis focussing on stem migration, bone remodelling, implant ingrowth
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
- follow-up at 1 and 5 years
- measurements at 0, 6wks, 3mnths, 6 mnths, 1yr, 2yr and 5yr
Onderzoeksproduct en/of interventie
- 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.
Publiek
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
Wetenschappelijk
PO Box 432
B.J.W. Thomassen
Den Haag 2501 CK
The Netherlands
+31 (0)70 3303109
b.thomassen@mchaaglanden.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1498 |
| NTR-old | NTR1568 |
| Ander register | Haaglanden Medical Center : 08-062 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |