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Comparative roentgen stereophotogrammetry analysis of the Taperloc stem with BoneMaster® nano-technology coating compared with cemented and uncemented porous coated Taperloc stem.


- candidate number4645
- NTR NumberNTR1568
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2008
- Secondary IDs08-062 Haaglanden Medical Center
- Public TitleComparative roentgen stereophotogrammetry analysis of the Taperloc stem with BoneMaster® nano-technology coating compared with cemented and uncemented porous coated Taperloc stem.
- Scientific TitleComparative roentgen stereophotogrammetry analysis of the Taperloc stem with BoneMaster® nano-technology coating compared with cemented and uncemented porous coated Taperloc stem.
- ACRONYMBoneMaster I & II
- hypothesisWe 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) studiedOsteoarthritis, Hip diseases, Total hip replacement, Arthroplasty
- Inclusion criteria1. 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2008
- planned closingdate30-jun-2016
- Target number of participants75
- 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 outcomeRadiographic analysis with roentgen stereophotogrammetry analysis focussing on stem migration, bone remodelling, implant ingrowth
- Secondary outcome- Harris Hip Score (HHS)
- HOOS
- SF-12
- Timepoints- follow-up at 1 and 5 years
- measurements at 0, 6wks, 3mnths, 6 mnths, 1yr, 2yr and 5yr
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. B.J.W. Thomassen
- CONTACT for SCIENTIFIC QUERIESDrs. B.J.W. Thomassen
- Sponsor/Initiator Haaglanden Medical Center, The Hague
- Funding
(Source(s) of Monetary or Material Support)
Haaglanden Medical Center, The Hague
- PublicationsN/A
- Brief summaryStability 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)
- RECORD1-dec-2008 - 19-mei-2014


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