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

Ullevaal University Hospital

Status: Unknown

Conditions: Femoral Neck Fractures

Treatments: Procedure: Uncemented primary bipolar hemiarthroplasty of the hip; Procedure: Cemented primary bipolar hemiarthroplasty of the hip

Study type: Interventional

Funder types: Other

Identifiers

NCT00491673

HEMI-SAB-UUS

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Uncemented

Active Comparator group

Description:

Uncemented primary bipolar hemiarthroplasty of the hip

Treatment:

Procedure: Uncemented primary bipolar hemiarthroplasty of the hip

Cemented

Active Comparator group

Description:

Cemented primary bipolar hemiarthroplasty of the hip

Treatment:

Procedure: Cemented primary bipolar hemiarthroplasty of the hip