Comparison of a Cemented, Polished Tapered Stem and an Anatomic Stem for Femoral Neck Fracture

May 11, 2016 updated by: Sundsvall Hospital
Postoperative periprosthetic femoral fracture after hip arthroplasty is associated with considerable morbidity and mortality. Recent cohort studies have demonstrated a high incidence of PPF in elderly patients treated with two commonly used polished, tapered, collarless stems in elderly patients. The aim of this study was to compare the rate and characteristics of PPF in a consecutive cohort of patients treated either the polished tapered CTP stem or the matte anatomic SP2 stem in an elderly population above 80 years of age with femoral neck fracture.

Study Overview

Study Type

Observational

Enrollment (Actual)

1014

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

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We included all patients above the age of 80 years old, operated between September 2009 and April 2015 with a primary hip arthroplasty for an acute displaced femoral neck fractures. Patients were treated either with the cemented CPT or SP2 stems.

Description

Inclusion Criteria:

  • Displaced femoral neck fracture
  • Treated with a primary hip arthroplasty

Exclusion Criteria:

  • Secondary arthroplasty due to sequel after femoral fracture

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

Cohorts and Interventions

Group / Cohort
CPT stem
Patients treated with a polished, tapered femoral stem as a hip arthroplasty for a displaced femoral neck fracture
SP2 stem
Patients treated with a anatomic femoral stem as a hip arthroplasty for a displaced femoral neck fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of periprosthetic femoral fracture
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 2 years
2 years
Type of periprosthetic femoral fracture
Time Frame: 2 years
2 years
Type of complications after surgery for periprosthetic femoral fracture
Time Frame: 2 years
2 years

Collaborators and Investigators

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

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.

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

September 1, 2009

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

October 28, 2015

First Posted (Estimate)

October 29, 2015

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

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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