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

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

Study Overview

• Status: Unknown
• Conditions: Femoral Neck Fractures
• Intervention / Treatment: Procedure: Cemented primary bipolar hemiarthroplasty of the hip; Procedure: Uncemented primary bipolar hemiarthroplasty of the hip

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.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0407
    • Ullevål University Hospital
  • Rud
    • Oslo, Rud, Norway, 1309
      • Sykehuset Asker And Baerum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cemented; Cemented primary bipolar hemiarthroplasty of the hip	Procedure: Cemented primary bipolar hemiarthroplasty of the hip; Cemented primary bipolar hemiarthroplasty of the hip; Other Names: Spectron, Smith & Nephew, Memphis, TN
Active Comparator: Uncemented; Uncemented primary bipolar hemiarthroplasty of the hip	Procedure: Uncemented primary bipolar hemiarthroplasty of the hip; Uncemented primary bipolar hemiarthroplasty of the hip; Other Names: Corail, DePuy/Johnson and Johnson, United Kingdom

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional outcome including pain (Harris Hip Score)	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ullevaal University Hospital
• Collaborators: Asker & Baerum Hospital
• Investigators: Study Director: Lars Nordsletten, Prof MD PhD, Ullevål University Hospital, University of Oslo; Study Chair: Lars Nordsletten, Prof MD PhD, Ullevål University Hospital, University of Oslo; Principal Investigator: Wender Figved, MD, PhD, Asker and Baerum Hospital; Principal Investigator: Ellen Langslet, MD, Ullevaal University Hospital

Publications and helpful links

Helpful Links

• Pubmed link to publication of 1-year results

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: June 25, 2007
• First Submitted That Met QC Criteria: June 25, 2007
• First Posted (Estimate): June 26, 2007

Study Record Updates

• Last Update Posted (Estimate): September 24, 2010
• Last Update Submitted That Met QC Criteria: September 23, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Arthroplasty; Fracture; Femoral neck
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: HEMI-SAB-UUS