Investigation on the Surgical Treatment Effect of Peripro... | NCT03358186

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

NCT03358186

Sponsor

Peking University People's Hospital

Status

Unknown status

Last Update Posted

Nov 30, 2017Actual

Enrollment

155Estimated

Phase

Not provided

Conditions

Periprosthetic Fractures

Interventions

surgically treated periprosthetic femur fracture

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2018Estimated

Primary Completion Date

Jul 1, 2019Estimated

Completion Date

Jul 1, 2019Estimated

First Submitted Date

Nov 26, 2017

First Submission Date that Met QC Criteria

Nov 26, 2017

First Posted Date

Nov 30, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 26, 2017

Last Update Posted Date

Nov 30, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

pengzhang, Department of orthopaedics and trauma, Peking University People's HospitalPrincipal Investigator

Lead Sponsor

Peking University People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

155Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
revision of periprosthetic fracture		patients with surgically treated periprosthetic femur fracture	Procedure: surgically treated periprosthetic femur fracture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgically treated periprosthetic femur fracture	Procedure	patients with surgically treated periprosthetic femur fracture	revision of periprosthetic fracture

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
hip function	Harris Hip Score	1 year after surgery
pain in fracture site	VAS score	1 year after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with periprosthetic femur fracture after hip arthroplasty

Exclusion Criteria:

Severe complications after surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

patients with surgically treated periprosthetic femur fracture after hip arthroplasty

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yichong Zhang	Contact	15210802766		875274428@qq.com

Overall Officials

Name	Affiliation	Role
Peng Zhang, MD	Peking University People's Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D057068	Periprosthetic Fractures

Ancestor Terms

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries

Browse Leaves

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Browse Branches

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