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

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ClinicalTrials.gov Identifier: NCT00491673
Recruitment Status : Unknown
Verified September 2010 by Ullevaal University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 2007
Last Update Posted : September 24, 2010
Sponsor:
Collaborator:
Asker & Baerum Hospital
Information provided by:
Ullevaal University Hospital

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


Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Procedure: Uncemented primary bipolar hemiarthroplasty of the hip Procedure: Cemented primary bipolar hemiarthroplasty of the hip Not Applicable

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  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
Study Start Date : September 2004
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Functional outcome including pain (Harris Hip Score) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 5 years ]
  2. Activities Of Daily Living (Barthels ADL-Index) [ Time Frame: 5 years ]
  3. Quality Of Life (EQ-5D) [ Time Frame: 5 years ]
  4. Any treatment related complication [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Lars Nordsletten, Ulleval university hospital
ClinicalTrials.gov Identifier: NCT00491673     History of Changes
Other Study ID Numbers: HEMI-SAB-UUS
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: September 24, 2010
Last Verified: September 2010

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
Hip Injuries
Leg Injuries