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

October 23, 2019 updated by: Sundsvall Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2527

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients at above mentioned centers presented with a femoral neck fracture treated with hip arthroplasty between 2006-2014 were followed 2017 or until death.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Patological fracture
  • Other typ of stem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lubinus SP2 stem
Patients treated with a cemented Lubinus SP2 stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included.
Procedure: Lubinus SP2 stem
Patients treated with an total or hemiarthroplasty using a SP2stem for a displaced femoral neck fracture
Exeter stem
Patients treated with a cemented Exeter stem for a femoral neck fracture. Both total hip arthroplasty and hemiarthroplasty are included.
Procedure: Exeter stem
Patients treated with an total or hemiarthroplasty using a Exeter stem for a displaced femoral neck fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2006-2014

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Riskfactors for periprosthetic fractures
Time Frame: 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)
2006-2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sundsvall Hospital

Collaborators

Karolinska Institutet
Sunderby Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

October 11, 2017

Study Registration Dates

First Submitted

October 11, 2017

First Submitted That Met QC Criteria

October 25, 2017

First Posted (Actual)

October 31, 2017

Study Record Updates

Last Update Posted (Actual)

October 24, 2019

Last Update Submitted That Met QC Criteria

October 23, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Multicenter_PPF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual data are presented.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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