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Clinical Trials/NCT03326271
NCT03326271CompletedNot Applicable

Postoperative Periprosthetic Fractures in Hip Fracture Patients: Comparison of the Exeter Stem and the Anatomic SP2 Lubinus Stem

Sundsvall Hospital0 sites2,527 target enrollmentStarted: May 4, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
2,527
Primary Endpoint
Periprosthetic femoral fractures

Study Overview

Brief Summary

Recent studies have indicated a high incidence of postoperative periprosthetic femoral fracture in elderly patients treated with two commonly used cemented polished, tapered femoral stems. The aim of this study was to compare the prevalence and incidence rate of PPF in a cohort of elderly with femoral neck fractures (FNF) treated with either a collarless, polished, tapered stem (Exeter) or an anatomic matte stem (Lubinus SP 2).

Patients and Methods In a multicentre retrospective cohort study 2529 patients 60 years and above, with a FNF as indication for primary surgery with a cemented hip arthroplasty were included. Patients were treated either with a polished tapered Exeter stem or a matte anatomic Lubinus SP12 stem according to the surgeons preference or to the praxis of the present department.

The incidence of perprosthetic femoral fractures Hip-related complications and repeat surgery were assessed at a minimum follow-up of 2 years postoperatively.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Femoral neck fracture
  • Treated with hip arthroplasty with Exeter or SP2 stem

Exclusion Criteria

  • Patological fracture
  • Other typ of stem

Outcomes

Primary Outcomes

Periprosthetic femoral fractures

Time Frame: 2006-2014

The incidence of postoperative periprosthetic femoral fractures are compared between the two groups studied (patients treated with Exeter stem or Lubinus SP2 stem. The hypothesis that the type of stem affects the incidence of periprosthetic femoral fractures are studied. The comparison will be analysed using cox proportional hazards or poisson regression analysis.

Secondary Outcomes

  • Riskfactors for periprosthetic fractures(2006-2014)

Investigators

Sponsor
Sundsvall Hospital
Sponsor Class
Other
Responsible Party
Sponsor

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