Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ? (PIH)
Primary Purpose
Femoral Neck Fractures
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
hemiarthroplasty for displaced femoral neck fractures
Sponsored by
About this trial
This is an interventional other trial for Femoral Neck Fractures
Eligibility 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)
Sites / Locations
- orthopedics department, University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cemented hemiarthroplasty
Uncemented hemiarthroplasty
Arm Description
hemiarthroplasty surgery with cement for displaced femoral neck fractures
hemiarthroplasty surgery without cement is a surgery for displaced femoral neck fractures
Outcomes
Primary Outcome Measures
Functionality
Functionality will be assessed at 3 and 12 month after surgery by Harris test scoring.
Secondary Outcome Measures
Full Information
NCT ID
NCT01787929
First Posted
January 17, 2013
Last Updated
April 17, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT01787929
Brief Title
Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ?
Acronym
PIH
Official Title
Cemented Versus Uncemented Hemiarthroplasty for Displaced Femoral Neck Fracture in Elderly Patient : a Randomized Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
February 7, 2016 (Actual)
Primary Completion Date
March 22, 2019 (Actual)
Study Completion Date
March 11, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cemented hemiarthroplasty
Arm Type
Other
Arm Description
hemiarthroplasty surgery with cement for displaced femoral neck fractures
Arm Title
Uncemented hemiarthroplasty
Arm Type
Other
Arm Description
hemiarthroplasty surgery without cement is a surgery for displaced femoral neck fractures
Intervention Type
Procedure
Intervention Name(s)
hemiarthroplasty for displaced femoral neck fractures
Intervention Description
Hemiarthroplasty is a surgery for displaced femoral neck fractures
Primary Outcome Measure Information:
Title
Functionality
Description
Functionality will be assessed at 3 and 12 month after surgery by Harris test scoring.
Time Frame
Changes at 3 and 12 month post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Regis BERNARD DE DOMPSURE, MD
Organizational Affiliation
University Nice Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
orthopedics department, University Hospital
City
Nice
ZIP/Postal Code
06000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Displaced Femoral Neck Fracture in Elderly Patient. Should Cement be Used for Hip Hemiarthroplasty ?
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