NCT01787929

Brief Summary

The purpose of this study was to identify the clinical relevance of cementless hemiarthroplasties, compare Harris functional score.The hypothesis is the non-inferiority of cementless hemiarthroplasties compare cemented hemiarthroplasties in order to justify the relevance of cementless hemiarthroplasties in displaced femoral neck fractures. 150 patients will be included, 75 with cemented hemiarthroplasty and 75 with uncemented hemiarthroplasty. They will be followed during one year after the surgery, with a functionality assessment at 3 month and 12 month.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 11, 2013

Completed
3 years until next milestone

Study Start

First participant enrolled

February 7, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2019

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

3.1 years

First QC Date

January 17, 2013

Last Update Submit

April 17, 2023

Conditions

Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

  • Functionality

    Functionality will be assessed at 3 and 12 month after surgery by Harris test scoring.

    Changes at 3 and 12 month post-operative

Study Arms (2)

Cemented hemiarthroplasty

OTHER

hemiarthroplasty surgery with cement for displaced femoral neck fractures

Procedure: hemiarthroplasty for displaced femoral neck fractures

Uncemented hemiarthroplasty

OTHER

hemiarthroplasty surgery without cement is a surgery for displaced femoral neck fractures

Procedure: hemiarthroplasty for displaced femoral neck fractures

Interventions

hemiarthroplasty for displaced femoral neck fracturesPROCEDURE

Hemiarthroplasty is a surgery for displaced femoral neck fractures

Cemented hemiarthroplastyUncemented hemiarthroplasty

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • displaced femoral neck fractures (Garden III and IV)
  • year old or more
  • ASA score \< or = III
  • Lee score \< or = 2

You may not qualify if:

  • Parker score \<4
  • pathological femoral neck fracture ( paget disease or tumor)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

orthopedics department, University Hospital

Nice, 06000, France

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Hemiarthroplasty

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Regis BERNARD DE DOMPSURE, MD

    University Nice Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2013

First Posted

February 11, 2013

Study Start

February 7, 2016

Primary Completion

March 22, 2019

Study Completion

March 11, 2020

Last Updated

April 19, 2023

Record last verified: 2023-04

Locations

FR(1)