Comparison of periprosthetic bone remodeling after implantation of anatomic and tapered cementless femoral stems in total hip arthroplasty: A prospective cohort study protocol.

INTRODUCTION

Current total hip arthroplasty (THA) implant usage trends favor cementless fixation, and plenty studies have demonstrated that numbers of cementless femoral stems are associated with excellent long-term survivorship and functional outcomes. Various types of cementless femoral stems have been developed and utilized in multiple applications, including straight, tapered, anatomic, customized, short, and even neck stems. All of these designs aimed to achieve maximal primary stability and promote osseointegration. Nevertheless, stress-shielding and periprosthetic bone loss continue to occur and remain critical issues in promoting long-term survivorship of THA. Considering anatomic and tapered stems are the most popular cementless designs today, this prospective cohort study aimed to investigate the effect of stem design on stress-shielding and periprosthetic bone remodeling after implantation of an anatomic stem with proximal fixation (Ribbed Hip system; Waldemar Link, Hamburg, Germany) and the direct comparison to a fully coated tapered stem (LCU Hip system; Waldemar Link).

MATERIALS AND METHODS

This prospective cohort study will comprise patients who receive primary unilateral THA with the Ribbed anatomic hydroxyapatite (HA)-coated stem or LCU tapered fully HA-coated stem. The changes in periprosthetic bone mineral density after insertion of Ribbed and LCU stem prostheses will be assessed by means of dual-energy X-ray absorptiometry in the periprosthetic region of interest according to Gruen and colleagues. Standard anteroposterior and lateral plain radiography will be performed for qualitative assessment of the periprosthetic bone remodeling. The following items will be analyzed or measured on follow-up radiographs to compare with the initial appearance on the radiographs taken immediately postoperatively: cortical thickness in each Gruen zone, fitness of the distal stem within the isthmus, femoral stem alignment, radiolucent line, reactive line, periosteal bone reactions, and subsidence. Biologic fixation and stability of the cementless implant will be evaluated using Engh grading scale, and heterotopic ossification will be graded according to Brooker classification. Furthermore, Harris hip score and Western Ontario and McMaster Universities Osteoarthritis Index Score will also be assessed for postoperative functional evaluation. These radiologic and clinical assessments will be taken postoperatively, at 6 months, 1, 2, 3, 4, and 5 years after surgery.

ETHICS AND DISSEMINATION

This study was approved by The First Affiliated Hospital of Chongqing Medical University Ethics Committee. The study results will be disseminated at national and international conferences and published in peer-reviewed journals.

STUDY REGISTRATION

Chinese Clinical Trial Registry (http://www.chictr.org.cn): ChiCTR1800017841.