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Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ? (PIH)

This study is currently recruiting participants.
Verified August 2017 by Centre Hospitalier Universitaire de Nice
Sponsor:
ClinicalTrials.gov Identifier:
NCT01787929
First Posted: February 11, 2013
Last Update Posted: September 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
  Purpose

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.


Condition Intervention
Femoral Neck Fractures Procedure: hemiarthroplasty for displaced femoral neck fractures

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Cemented Versus Uncemented Hemiarthroplasty for Displaced Femoral Neck Fracture in Elderly Patient : a Randomized Prospective Trial

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • Functionality [ Time Frame: Changes at 3 and 12 month post-operative ]
    Functionality will be assessed at 3 and 12 month after surgery by Harris test scoring.


Estimated Enrollment: 150
Actual Study Start Date: February 7, 2016
Estimated Study Completion Date: February 7, 2019
Estimated Primary Completion Date: February 7, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Cemented hemiarthroplasty
hemiarthroplasty surgery with cement for displaced femoral neck fractures
Procedure: hemiarthroplasty for displaced femoral neck fractures
Hemiarthroplasty is a surgery for displaced femoral neck fractures
Uncemented hemiarthroplasty
hemiarthroplasty surgery without cement is a surgery for displaced femoral neck fractures
Procedure: hemiarthroplasty for displaced femoral neck fractures
Hemiarthroplasty is a surgery for displaced femoral neck fractures

Detailed Description:

Most subcapital femoral neck fractures occur in the elderly population and are the result of low-energy trauma. Return of the patient to prefracture level of function usually can best be accomplished with surgery. Nonsurgical management has resulted in an excessive rate of medical morbidity and mortality. The overall 1-year mortality rate after hip fracture in the elderly ranges from 14% to 36%.

Prosthetic replacement has been favored for the treatment of displaced femoral neck fractures in the frail, elderly population with multiple medical comorbidities because of the challenges of achieving stable proximal fragment fixation in osteopenic bone, and the need for early, full weight-bearing mobilization. Failure rates of 30% to 40% have been consistently reported over multiple series over the past few decades in elderly patients with displaced femoral neck fractures treated with internal fixation.

Once prosthetic arthroplasty has been chosen, further controversy surrounds the type of fixation, cemented or cementless. Good to excellent results can be expected with either cemented or cementless newer generation arthroplasties. Risks of cementless arthroplasty include femoral fracture, prosthesis subsidence, and anterior thigh pain. Cementation of the prosthesis places the patient at risk for intraoperative death or embolization of marrow content during cementation.

The aim of the study is to assess the clinical relevance of a collared uncemented stem compared with use of cemented stem in elderly population with displaced femoral neck fracture.

A randomised trial will include 150 patients with an acute displaced femoral neck fracture in an elderly population. All patient will give informed consent, and the research protocol is approved by the regional ethics committee. The inclusion criteria are an age of at least 70 years old, a displaced femoral neck fracture (Garden stage III or IV), an ASA grade< 4, ambulatory and non cognive impairment patients. Clinical and radiographic examinations will be perform at perioperative period, at 3 and 12 month after surgery. The main outcome measures will be functional score, pain, mobility, complications, reoperations, activity of daily living, quality of life, strenght, and radiolographic subsidence.

The primary hypothesis of this study is that use of a collared uncemented stem would not provide an improvement in functional outcome compared with use of cemented stem in elderly population with displaced femoral neck fracture.

  Eligibility

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Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Parker score <4
  • pathological femoral neck fracture ( paget disease or tumor)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787929


Contacts
Contact: Régis BERNARD DE DOMPSURE, MD bernard-de-dompsure.r@chu-nice.fr

Locations
France
orthopedics department, University Hospital Recruiting
Nice, France, 06000
Principal Investigator: Regis BERNARD DE DOMPSURE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Regis BERNARD DE DOMPSURE, MD University Nice Hospital
  More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01787929     History of Changes
Other Study ID Numbers: 12-PP-10
First Submitted: January 17, 2013
First Posted: February 11, 2013
Last Update Posted: September 1, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries