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

Not Applicable

• Conditions: Femoral Neck Fractures
• Interventions: Procedure: Uncemented primary bipolar hemiarthroplasty of the hip; Procedure: Cemented primary bipolar hemiarthroplasty of the hip

• Registration Number: NCT00491673
• Lead Sponsor: 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

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Status Verified: 2010-09
• Last Update Submitted: 2010-09-23
• Last Update Posted: 2010-09-24
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncemented	Uncemented primary bipolar hemiarthroplasty of the hip	Uncemented primary bipolar hemiarthroplasty of the hip
Cemented	Cemented primary bipolar hemiarthroplasty of the hip	Cemented primary bipolar hemiarthroplasty of the hip

Primary Outcome Measures

Name	Time	Method
Functional outcome including pain (Harris Hip Score)	5 years

Secondary Outcome Measures

Name	Time	Method
All Cause Mortality	5 years
Activities Of Daily Living (Barthels ADL-Index)	5 years
Quality Of Life (EQ-5D)	5 years
Any treatment related complication	5 years

Trial Locations

Locations (2)

Sykehuset Asker And Baerum; 🇳🇴 Oslo, Rud, Norway

Ullevål University Hospital; 🇳🇴 Oslo, Norway