Clinical trial NCT00491673: A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
Official title: A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Neck Fractures
Keywords: Fracture
Femoral neck
Arthroplasty
Lead sponsor: Ullevaal University Hospital
Sponsor class: OTHER
Collaborators: name: Asker & Baerum Hospital
First posted: 2007-06-26
Enrollment: 230
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional outcome including pain (Harris Hip Score)
timeFrame: 5 years
Secondary outcomes:
measure: All Cause Mortality
timeFrame: 5 years
measure: Activities Of Daily Living (Barthels ADL-Index)
timeFrame: 5 years
measure: Quality Of Life (EQ-5D)
timeFrame: 5 years
measure: Any treatment related complication
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Sykehuset Asker And Baerum
state: Rud
city: Oslo
country: Norway
facility: Ullevål University Hospital
Study officials:
affiliation: Ullevål University Hospital, University of Oslo
name: Lars Nordsletten, Prof MD PhD
role: STUDY_CHAIR
affiliation: Asker and Baerum Hospital
name: Wender Figved, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ullevål University Hospital, University of Oslo
name: Lars Nordsletten, Prof MD PhD
role: STUDY_DIRECTOR
affiliation: Ullevaal University Hospital
name: Ellen Langslet, MD
role: PRINCIPAL_INVESTIGATOR
References: