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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Ullevaal University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Asker & Baerum Hospital
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00491673
First received: June 25, 2007
Last updated: September 23, 2010
Last verified: September 2010
  Purpose

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


Condition Intervention
Femoral Neck Fractures
Procedure: Uncemented primary bipolar hemiarthroplasty of the hip
Procedure: Cemented primary bipolar hemiarthroplasty of the hip

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Functional outcome including pain (Harris Hip Score) [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All Cause Mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Activities Of Daily Living (Barthels ADL-Index) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality Of Life (EQ-5D) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Any treatment related complication [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 230
Study Start Date: September 2004
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Corail, DePuy/Johnson and Johnson, United Kingdom
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 Name: Spectron, Smith & Nephew, Memphis, TN

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491673

Locations
Norway
Sykehuset Asker And Baerum
Oslo, Rud, Norway, 1309
Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Asker & Baerum Hospital
Investigators
Study Chair: Lars Nordsletten, Prof MD PhD Ullevål University Hospital, University of Oslo
Principal Investigator: Wender Figved, MD, PhD Asker and Baerum Hospital
Study Director: Lars Nordsletten, Prof MD PhD Ullevål University Hospital, University of Oslo
Principal Investigator: Ellen Langslet, MD Ullevaal University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Lars Nordsletten, Ulleval university hospital
ClinicalTrials.gov Identifier: NCT00491673     History of Changes
Other Study ID Numbers: HEMI-SAB-UUS
Study First Received: June 25, 2007
Last Updated: September 23, 2010
Health Authority: Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Ullevaal University Hospital:
Fracture
Femoral neck
Arthroplasty

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

ClinicalTrials.gov processed this record on October 19, 2014