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A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures (HEMI04)

Primary Purpose

Femoral Neck Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Uncemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Fracture, Femoral neck, Arthroplasty

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Dislocated intracapsular femoral neck fracture
  • ≥ 70 years old

Exclusion Criteria:

  • Pathological fracture
  • Systemic or local infection
  • Short life expectancy/not mobile at all
  • Symptomatic coxarthrosis

Sites / Locations

  • Sykehuset Asker And Baerum
  • Ullevål University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Uncemented

Cemented

Arm Description

Uncemented primary bipolar hemiarthroplasty of the hip

Cemented primary bipolar hemiarthroplasty of the hip

Outcomes

Primary Outcome Measures

Functional outcome including pain (Harris Hip Score)

Secondary Outcome Measures

All Cause Mortality
Activities Of Daily Living (Barthels ADL-Index)
Quality Of Life (EQ-5D)
Any treatment related complication

Full Information

First Posted
June 25, 2007
Last Updated
September 23, 2010
Sponsor
Ullevaal University Hospital
Collaborators
Asker & Baerum Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00491673
Brief Title
A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
Acronym
HEMI04
Official Title
A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital
Collaborators
Asker & Baerum Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly No definite conclusions have been made in regards to what kind of arthroplasty is favourable Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality. Cementless implants are associated with increased postoperative pain and decreased walking ability. This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs. Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years
Detailed Description
Inclusion Criteria: Dislocated intracapsular femoral neck fracture in patients ≥ 70 years old Exclusion criteria: Pathological fracture, Systemic or local infection, Short life expectancy/not mobile at all, Symptomatic coxarthrosis. Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year (SD of HHS is 15 points) Power: 95% Significance: 0.05 60 patients in each group needed. To compensate for high mortality and drop-out: 200 patients, 100 in each group Randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent. Recorded after surgery: Operating time Arthroplasty components used Need of blood transfusion Blood loss Size of incision Recorded at discharge, 3 months, 1 year and 5 years: X-ray of pelvis and hip Harris Hip Score Barthels ADL-index Quality of life (EQ-5D) Use of analgetics Use of walking aids Publication: International orthopaedic journal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Fracture, Femoral neck, Arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uncemented
Arm Type
Active Comparator
Arm Description
Uncemented primary bipolar hemiarthroplasty of the hip
Arm Title
Cemented
Arm Type
Active Comparator
Arm Description
Cemented primary bipolar hemiarthroplasty of the hip
Intervention Type
Procedure
Intervention Name(s)
Uncemented primary bipolar hemiarthroplasty of the hip
Other Intervention Name(s)
Corail, DePuy/Johnson and Johnson, United Kingdom
Intervention Description
Uncemented primary bipolar hemiarthroplasty of the hip
Intervention Type
Procedure
Intervention Name(s)
Cemented primary bipolar hemiarthroplasty of the hip
Other Intervention Name(s)
Spectron, Smith & Nephew, Memphis, TN
Intervention Description
Cemented primary bipolar hemiarthroplasty of the hip
Primary Outcome Measure Information:
Title
Functional outcome including pain (Harris Hip Score)
Time Frame
5 years
Secondary Outcome Measure Information:
Title
All Cause Mortality
Time Frame
5 years
Title
Activities Of Daily Living (Barthels ADL-Index)
Time Frame
5 years
Title
Quality Of Life (EQ-5D)
Time Frame
5 years
Title
Any treatment related complication
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Dislocated intracapsular femoral neck fracture ≥ 70 years old Exclusion Criteria: Pathological fracture Systemic or local infection Short life expectancy/not mobile at all Symptomatic coxarthrosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, Prof MD PhD
Organizational Affiliation
Ullevål University Hospital, University of Oslo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wender Figved, MD, PhD
Organizational Affiliation
Asker and Baerum Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lars Nordsletten, Prof MD PhD
Organizational Affiliation
Ullevål University Hospital, University of Oslo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ellen Langslet, MD
Organizational Affiliation
Ullevaal University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sykehuset Asker And Baerum
City
Oslo
State/Province
Rud
ZIP/Postal Code
1309
Country
Norway
Facility Name
Ullevål University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway

12. IPD Sharing Statement

Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19130162
Description
Pubmed link to publication of 1-year results

Learn more about this trial

A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures

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