NCT00491673

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Ullevaal University Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Femoral Neck Fractures

Interventions

Type	Name	Description
PROCEDURE	Uncemented primary bipolar hemiarthroplasty of the hip	Uncemented primary bipolar hemiarthroplasty of the hip
PROCEDURE	Cemented primary bipolar hemiarthroplasty of the hip	Cemented primary bipolar hemiarthroplasty of the hip

Timeline

• Start date: 2004-09-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-06-26
• Last updated: 2010-09-24

Locations

2 sites across 1 country: Norway