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
Source
Brief title
Health condition
proximal intracapsular femoral fracture, mediale collum fractuur, cement, hydroxy-apatite coated uncemented, hemi-arthroplasty, kophals prothese
Sponsors and support
LUMC
LUMC
Intervention
Outcome measures
Primary outcome
The primary outcome is a composite endpoint of Serious Adverse Events.
Secondary outcome
Secundary study parameters are post-surgery delirium, surgical time, radiological evaluation, pain, complications and mobilisation.
Background summary
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
Study objective
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.
Study design
0-30 days (Serious Adverse Events), 6 weeks, 12 weeks and 1 year follow-up.
Intervention
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.
Haga Ziekenhuis, afd. Heelkunde,
Leyweg 275
Den Haag 2545 CH
The Netherlands
+31 (0)70 2100000
krik78@hotmail.com
Haga Ziekenhuis, afd. Heelkunde,
Leyweg 275
Den Haag 2545 CH
The Netherlands
+31 (0)70 2100000
krik78@hotmail.com
Inclusion criteria
The elderly patient with a proximal intracapsular femoral fracture who should be treated with a hemi-arthroplasty.
Exclusion criteria
Multiple trauma patient Pathological fracture Symptomatic coxarthritis at the ipsilateral side Osteosynthesis revision.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1681 |
| NTR-old | NTR1782 |
| CCMO | NL23995.098.08 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |
| OMON | NL-OMON33945 |