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Open Access Study protocol

Cemented versus non-cemented hemiarthroplasty of the hip as a treatment for a displaced femoral neck fracture: design of a randomised controlled trial

Anne JH Vochteloo1, DieuDonné Niesten1, Roeland Riedijk2, Willard J Rijnberg2, Stefan BT Bolder2, Sander Koëter3, Keetie Kremers-van de Hei3, Taco Gosens4 and Peter Pilot1*

Author Affiliations

1 Department of Orthopaedics, Reinier de Graaf Gasthuis Delft, PO box 5011, 2600 GA, Delft, The Netherlands

2 Department of Orthopaedics, Ziekenhuis Rijnstate Alysis Zorggroep Arnhem, PO box 9555, 6800 TA, Arnhem, The Netherlands

3 Department of Orthopaedics, Canisius Wilhelmina Ziekenhuis Nijmegen, PO box 9015, 6500 GS, Nijmegen, The Netherlands

4 Department of Orthopaedics, Elisabeth Ziekenhuis Tilburg, PO box 90151, 5000 LC, Tilburg, The Netherlands

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BMC Musculoskeletal Disorders 2009, 10:56  doi:10.1186/1471-2474-10-56

Published: 28 May 2009

Abstract

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 and design

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.

Conclusion

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.

Trial Registration

Trial Registration Number NTR1508