Postoperative Periprosthetic Fractures in Hip Fracture Patients: Exeter vs Anatomic SP2 Lubinus Stem

Completed

• Conditions: Periprosthetic Fractures; Femoral Neck Fractures
• Interventions: Procedure: Lubinus SP2 stem; Procedure: Exeter stem

• Registration Number: NCT03326271
• Lead Sponsor: Sundsvall Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-04
• Primary Completion: 2017-04-01
• Study Completion: 2017-10-11
• Study First Submitted: 2017-10-11
• Study First Submitted QC: 2017-10-25
• Study First Posted: 2017-10-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-23
• Last Update Posted: 2019-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2527

Inclusion Criteria

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

Exclusion Criteria

• Patological fracture
• Other typ of stem

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lubinus SP2 stem	Lubinus SP2 stem	Patients treated with a cemented Lubinus SP2 stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included.
Exeter stem	Exeter stem	Patients treated with a cemented Exeter stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included.

Primary Outcome Measures

Name	Time	Method
Periprosthetic femoral fractures	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 Outcome Measures

Name	Time	Method
Riskfactors for periprosthetic fractures	2006-2014	Sex (male or female), age (years), ASA class (1-2 or 3-4), Exeter stem size (0-2, 3-4, 5-6) and surgical approach (direct lateral or posterolateral) type of stem used (Lubinus Sp2 or Exeter stem)