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Randomised Clinical Trial comparing cemented and hydroxy-apatite coated uncemented hemi-arthroplasty in the elderly patient with a proximal intracapsular femoral fracture.


- candidate number5667
- NTR NumberNTR1782
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-apr-2009
- Secondary IDsNL23995.098.08  ABR nummer
- Public TitleRandomised Clinical Trial comparing cemented and hydroxy-apatite coated uncemented hemi-arthroplasty in the elderly patient with a proximal intracapsular femoral fracture.
- Scientific TitleRandomised Clinical Trial comparing cemented and hydroxy-apatite coated uncemented hemi-arthroplasty in the elderly patient with a proximal intracapsular femoral fracture.
- ACRONYMCemented versus hydroxy-apatite coated uncemented hemi-arthroplasty.
- hypothesisIn the elderly patient with a proximal intracapsular femoral fracture a hydroxy-apatite coated uncemented hemi-arthroplasty will lead to a lower mortality rate and less servere complications compared to a cemented hemi-arthroplasty.
- Healt Condition(s) or Problem(s) studiedMedial collum fracture, Proximal femoral fracture
- Inclusion criteriaThe elderly patient with a proximal intracapsular femoral fracture who should be treated with a hemi-arthroplasty.
- Exclusion criteriaMultiple trauma patient Pathological fracture Symptomatic coxarthritis at the ipsilateral side Osteosynthesis revision.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate30-jun-2012
- Target number of participants400
- InterventionsCemented versus hydroxy-apatite coated uncemented hemi-arthroplasty by patients of 65 years or older with a proximal intracapsular femoral fracture and the indication of a hemi-arthroplasty.
- Primary outcomeThe primary outcome is a composite endpoint of Serious Adverse Events.
- Secondary outcomeSecundary study parameters are post-surgery delirium, surgical time, radiological evaluation, pain, complications and mobilisation.
- Timepoints0-30 days (Serious Adverse Events), 6 weeks, 12 weeks and 1 year follow-up.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. C.H.W. Heusdens
- CONTACT for SCIENTIFIC QUERIESDrs. C.H.W. Heusdens
- Sponsor/Initiator Haga Hospital, Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC), Haga Hospital
- PublicationsN/A
- Brief summaryPublished studies comparing morbidity/mortality and post-operative functional outcome after cemented or uncemented hemi-arthroplasty are mostly retrospective. So far no study has been published comparing the newer, commonly used, hydroxy-apatite coated hemi-arthroplasty. The recent Cochrane Review on this subject concludes that no definitive conlusions can be made and further well-conducted randomised trials are required
- Main changes (audit trail)
- RECORD28-apr-2009 - 23-sep-2009


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