Investigation on the Surgical Treatment Effect of Periprosthetic Femur Fracture After Hip Arthroplasty

November 26, 2017 updated by: pengzhang, Peking University People's Hospital

A Multi-center Study on Investigating the Surgical Treatment Effect of Periprosthetic Femur Fracture After Hip Arthroplasty

To Investigate the Surgical Treatment effect of Periprosthetic Femur Fracture After Hip Arthroplasty

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In the study，155 patients from multiple center with periprosthetic femur fracture after hip arthroplasty are planned to be recruited. All the patients are treated surgically according to Vancouver classification，and their fracture union，pain in fracture site and lower extremity length are evaluated at 6 months and 1 year postoperatively．Also Harris scores are used to assess hip function at the 2 time points.

Study Type

Observational

Enrollment (Anticipated)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

53 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with surgically treated periprosthetic femur fracture after hip arthroplasty

Description

Inclusion Criteria:

patients with periprosthetic femur fracture after hip arthroplasty

Exclusion Criteria:

Severe complications after surgery

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: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
revision of periprosthetic fracture
patients with surgically treated periprosthetic femur fracture
Procedure: surgically treated periprosthetic femur fracture
patients with surgically treated periprosthetic femur fracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fracture union
Time Frame: 1 year after surgery
fracture union from X-ray
1 year after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hip function
Time Frame: 1 year after surgery
Harris Hip Score
1 year after surgery
pain in fracture site
Time Frame: 1 year after surgery
VAS score
1 year after surgery
lower extremity length
Time Frame: 1 year after surgery
The lengths of injured lower extremity
1 year after surgery

Collaborators and Investigators

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

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Peng Zhang, MD, Peking University People's Hospital

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 (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2019

Study Registration Dates

First Submitted

November 26, 2017

First Submitted That Met QC Criteria

November 26, 2017

First Posted (Actual)

November 30, 2017

Study Record Updates

Last Update Posted (Actual)

November 30, 2017

Last Update Submitted That Met QC Criteria

November 26, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • csg-pffh

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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