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Completed

NCT Number: NCT03326271

Postoperative Periprosthetic Fractures in Hip Fracture Patients: Exeter vs 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.

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Key information

Conditions

Femoral Neck Fractures Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Periprosthetic Fractures Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patological fracture
  • Other typ of stem

Treatment and study plan

Exeter stem

Procedure

Patients treated with an total or hemiarthroplasty using a Exeter stem for a displaced femoral neck fracture

Lubinus SP2 stem

Procedure

Patients treated with an total or hemiarthroplasty using a SP2stem for a displaced femoral neck fracture

Primary outcomes

  1. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Sundsvall Hospital

Other

Collaborators

  • Karolinska Institutet
  • Sunderby Hospital

Registry information

Official study title

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

Acronym: PPFEvL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 31, 2017
Registry last updated
Oct 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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