Cemented versus non-cemented hemiarthroplasty of the hip as a treatment for a displaced femoral neck fracture: design of a randomised controlled trial.
BACKGROUND
A discussion is ongoing whether displaced femoral neck fractures in elderly patients should be treated with a non-cemented or a cemented hemiarthroplasty. A recent Cochrane analysis stresses the importance of further research into the relative merits of these techniques. We hypothesise that non-cemented hemiarthroplasty will result in at least the same technical-functional outcome and complication rate, with a shorter operation time.


METHODS
A randomised controlled multicentre trial will be performed.The study population consists of 200 patients of 70 years and older. Patients with a displaced femoral neck fracture will be allocated randomly to have a cemented or a non-cemented hemiarthroplasty. Data will be collected preoperatively, immediately postoperatively, and 6 weeks, 3 months and 1 year postoperatively.The main outcome measures of this study are technical-functional results of the hemiarthroplasty, duration of surgery, complications, and mid-thigh pain. Secondary outcome measures are living conditions at final follow up, self-reported health-related quality of life, and radiological evaluation of the hemiarthroplasty.


CONCLUSIONS
A recent Cochrane analysis did not find arguments in favour of either non-cemented or cemented hemiarthroplasty. The forthcoming trial will compare treatment for a displaced femoral neck fracture by cemented versus non-cemented hemiarthroplasty. Our results will be published as soon as they become available.


BACKGROUND
Trial Registration Number NTR1508.
Vochteloo
Anne J H
AJ
Department of Orthopaedics, Reinier de Graaf Gasthuis Delft, Delft, The Netherlands. ajhvochteloo@rdgg.nl
Niesten
DieuDonné
D
Riedijk
Roeland
R
Rijnberg
Willard J
WJ
Bolder
Stefan B T
SB
Koëter
Sander
S
Kremers-van de Hei
Keetie
K
Gosens
Taco
T
Pilot
Peter
P
D000203:Activities of Daily Living / Q000523:psychology; D000367:Age Factors; D000368:Aged; D019644:Arthroplasty, Replacement, Hip / Q000379:methods*; D001843:Bone Cements / Q000592:standards / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000379:methods; D023381:Endpoint Determination; D005260:Female; D005265:Femoral Neck Fractures / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery*; D005272:Femur Neck / Q000293:injuries / Q000473:pathology / Q000601:surgery*; D005548:Foreign-Body Migration / Q000517:prevention & control; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care / Q000379:methods; D010149:Postoperative Pain / Q000517:prevention & control; D019736:Prostheses and Implants / Q000592:standards*; D011788:Quality of Life / Q000523:psychology; D011859:Radiography; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
D001843:Bone Cements