In 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.
ID
Bron
Verkorte titel
Aandoening
proximal intracapsular femoral fracture, mediale collum fractuur, cement, hydroxy-apatite coated uncemented, hemi-arthroplasty, kophals prothese
Ondersteuning
LUMC
LUMC
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome is a composite endpoint of Serious Adverse Events.
Achtergrond van het onderzoek
Published 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
Doel van het onderzoek
In 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.
Onderzoeksopzet
0-30 days (Serious Adverse Events), 6 weeks, 12 weeks and 1 year follow-up.
Onderzoeksproduct en/of interventie
Cemented 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.
Publiek
Haga Ziekenhuis, afd. Heelkunde,
Leyweg 275
Den Haag 2545 CH
The Netherlands
+31 (0)70 2100000
krik78@hotmail.com
Wetenschappelijk
Haga Ziekenhuis, afd. Heelkunde,
Leyweg 275
Den Haag 2545 CH
The Netherlands
+31 (0)70 2100000
krik78@hotmail.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
The elderly patient with a proximal intracapsular femoral fracture who should be treated with a hemi-arthroplasty.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Multiple trauma patient
Pathological fracture
Symptomatic coxarthritis at the ipsilateral side
Osteosynthesis revision.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL1681 |
NTR-old | NTR1782 |
CCMO | NL23995.098.08 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |
OMON | NL-OMON33945 |