Undisplaced Femoral Neck Fractures (UNFNF)

January 1, 2018 updated by: Sundsvall Hospital

Undisplaced Femoral Neck Fractures: Treatment With Internal Fixation or Hip Arthroplasty

Purpose The purpose of this study is to compare the clinical outcome and the rate of reoperations in a cohort of patients with undisplaced femoral neck fractures treated with internal fixation and patients with displaced femoral neck fractures treated with hip arthroplasty.

Methods In a consecutive series of patients we compared the results of internal fixation for undisplaced femoral neck fractures with those of hip arthroplasty for displaced fractures (control group) of elderly patients. Risk of reoperation and patient reported hip function assessed with Harris hip score and WOMAC were used as outcome measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

235

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

To evaluate the potential benefit of surgery with arthroplasty. All patients treated at Sundsvall hospital, Sweden for a displaced femoral neck fracture treated with hip arthroplasty or a undisplaced femoral neck fracture treated with internal fixation were included in a prospective cohort study.

Description

Inclusion Criteria:

Above 65 years old Displaced femoral neck fracture treated with hip arthroplasty Undisplaced femoral neck fracture treated with internal fixation

Exclusion Criteria:

  • Pathologic 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
Intervention / Treatment
Internal fixation
Patients above 65years old with an undisplaced femoral neck fractures treated with primary internal fixation with screws.
Device: Internal fixation or hip arthroplasty
Patients treated according to the routine at the orthopedic department with screw fixation of an undisplayed femoral neck fracture or hip arthroplasty for a displaced femoral neck fracture.
Hip arthroplasty
Patients above 65years old with a displaced femoral neck fractures treated with primary hip arthroplasty.
Device: Internal fixation or hip arthroplasty
Patients treated according to the routine at the orthopedic department with screw fixation of an undisplayed femoral neck fracture or hip arthroplasty for a displaced femoral neck fracture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation
Time Frame: 4 years
Reapportions are recorded and compared between the groups.
4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: 1 year postoperatively
Patient reported outcome (0-100 points) for evaluation of hip function.
1 year postoperatively
WOMAC
Time Frame: 1 year postoperatively
Patient reported outcome (0-96 points) for evaluation of hip function.
1 year postoperatively
Pain in the operated hip
Time Frame: 1 year postoperatively
Estimated with pain numeric rating scale (PNRS). Grading 0-10.
1 year postoperatively

Collaborators and Investigators

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

Sponsor

Sundsvall 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)

January 1, 2013

Primary Completion (Actual)

May 31, 2015

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

January 1, 2018

First Submitted That Met QC Criteria

January 1, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

January 5, 2018

Last Update Submitted That Met QC Criteria

January 1, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFNF_IFvsHA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If researchers requests data - anonymous data will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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