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

History of Changes

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:

MedlinePlus related topics: Fractures

U.S. FDA Resources

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

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:

Pubmed link to publication of 1-year results This link exits the ClinicalTrials.gov site

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:

Femoral Neck Fractures
Fractures, Bone
Hip Fractures

Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on June 18, 2013

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