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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00491673
Acronym
HEMI04
Enrollment
230
Registered
2007-06-26
Start date
2004-09-30
Completion date
2010-12-31
Last updated
2010-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fractures

Keywords

Fracture, Femoral neck, Arthroplasty

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.

Interventions

Uncemented primary bipolar hemiarthroplasty of the hip

Cemented primary bipolar hemiarthroplasty of the hip

Sponsors

Asker & Baerum Hospital
CollaboratorOTHER
Ullevaal University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Functional outcome including pain (Harris Hip Score)5 years

Secondary

MeasureTime frame
All Cause Mortality5 years
Activities Of Daily Living (Barthels ADL-Index)5 years
Quality Of Life (EQ-5D)5 years
Any treatment related complication5 years

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026