Study protocol

A new short uncemented, proximally fixed anatomic femoral implant with a prominent lateral flare: design rationals and study design of an international clinical trial

Tobias Renkawitz¹ , Francesco S Santori² , Joachim Grifka¹ , Carlos Valverde⁴ , Michael M Morlock⁵ and Ian D Learmonth³

¹  Regensburg University Medical Center, Bad Abbach, Germany

²  Ospedale San Pietro Fatebenefratelli, Rome, Italy

³  University of Bristol, Bristol, UK

⁴  Hospital Arnau de Vilanova, Valencia, Spain

⁵  Hamburg University of Technology, Hamburg, Germany

author email corresponding author email

BMC Musculoskeletal Disorders 2008, 9:147doi:10.1186/1471-2474-9-147

Published:	4 November 2008

Abstract

Background

Anatomic short femoral prostheses with a prominent lateral flare have the potential to reduce stress-shielding in the femur through a more physiological stress distribution to the proximal femur. We present the design rationale of a new short uncemented, proximally fixed anatomic femoral implant and the study design of a prospective multi-centre trial to collect long-term patient outcome and radiographic follow up data.

Methods

A prospective surveillance study (trial registry NCT00208555) in four European centres (UK, Italy, Spain and Germany) with a follow up period of 15 years will be executed. The recruitment target is 200 subjects, patients between the ages of 18 and 70 admitted for primary cementless unilateral THA will be included. The primary objective is to evaluate the five-year survivorship of the new cementless short stem. The secondary objectives of this investigation are to evaluate the long term survivorship and the clinical performance of the implant, the impact on the subjects health related Quality of Life and the affect of the prosthesis on bone mineral density. Peri- and postoperative complications will be registered. Clinical and radiographic evaluation of prosthesis positioning will be done post-operatively and at 3, 6, 12, 24, 60, 120 and 180 months follow up.

Discussion

Shortening of the distal stem can maximise bone and soft tissue conservation. New stem types have been designed to improve the limitations of traditional implants in primary THA. A new, uncemented femoral short stem is introduced in this paper. A long-term follow up study has been designed to verify stable fixation and to research into the clinical outcome. The results of this trial will be presented as soon as they become available.