A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Femoral Neck Fractures
- Sponsor
- Ullevaal University Hospital
- Enrollment
- 230
- Locations
- 2
- Primary Endpoint
- Functional outcome including pain (Harris Hip Score)
- Last Updated
- 15 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Functional outcome including pain (Harris Hip Score)
Time Frame: 5 years
Secondary Outcomes
- 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)