Overview

This trial is active, not recruiting.

Condition femoral neck fractures
Treatments uncemented primary bipolar hemiarthroplasty of the hip, cemented primary bipolar hemiarthroplasty of the hip
Sponsor Ullevaal University Hospital
Collaborator Asker & Baerum Hospital
Start date September 2004
End date December 2010
Trial size 230 participants
Trial identifier NCT00491673, HEMI-SAB-UUS

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Uncemented primary bipolar hemiarthroplasty of the hip
uncemented primary bipolar hemiarthroplasty of the hip Corail, DePuy/Johnson and Johnson, United Kingdom
Uncemented primary bipolar hemiarthroplasty of the hip
(Active Comparator)
Cemented primary bipolar hemiarthroplasty of the hip
cemented primary bipolar hemiarthroplasty of the hip Spectron, Smith & Nephew, Memphis, TN
Cemented primary bipolar hemiarthroplasty of the hip

Primary Outcomes

Measure
Functional outcome including pain (Harris Hip Score)
time frame: 5 years

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 70 years old.

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

Additional Information

Official title A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
Principal investigator Wender Figved, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by Ullevaal University Hospital.