|- candidate number||4645|
|- NTR Number||NTR1568|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-dec-2008|
|- Secondary IDs||08-062 Haaglanden Medical Center|
|- Public Title||Comparative roentgen stereophotogrammetry analysis of the Taperloc stem with BoneMaster® nano-technology coating compared with cemented and uncemented porous coated Taperloc stem.|
|- Scientific Title||Comparative roentgen stereophotogrammetry analysis of the Taperloc stem with BoneMaster® nano-technology coating compared with cemented and uncemented porous coated Taperloc stem.|
|- ACRONYM||BoneMaster I & II|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Osteoarthritis, Hip diseases, Total hip replacement, Arthroplasty |
|- 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
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2008|
|- planned closingdate||30-jun-2016|
|- Target number of participants||75|
|- Interventions||- 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.
|- Primary outcome||Radiographic analysis with roentgen stereophotogrammetry analysis focussing on stem migration, bone remodelling, implant ingrowth |
|- Secondary outcome||- Harris Hip Score (HHS)|
|- Timepoints||- follow-up at 1 and 5 years|
- measurements at 0, 6wks, 3mnths, 6 mnths, 1yr, 2yr and 5yr
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Drs. B.J.W. Thomassen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. B.J.W. Thomassen|
|- Sponsor/Initiator ||Haaglanden Medical Center, The Hague|
(Source(s) of Monetary or Material Support)
|Haaglanden Medical Center, The Hague|
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||1-dec-2008 - 19-mei-2014|