Overview

This trial is active, not recruiting.

Condition femoral neck fractures
Treatments cemented total hip arthroplasty, cemented hemiarthroplasty
Sponsor Danderyd Hospital
Start date October 2009
End date October 2016
Trial size 120 participants
Trial identifier NCT02246335, HOPE

Summary

Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Hemiarthroplasty
cemented hemiarthroplasty
(Active Comparator)
Total hip arthroplasty
cemented total hip arthroplasty

Primary Outcomes

Measure
Harris hip score
time frame: 2 years

Secondary Outcomes

Measure
EQ-5D
time frame: 2 years
EQ-5D
time frame: 4 years
EQ-5D
time frame: 6 years
EQ-5D
time frame: 10 years
Adverse events
time frame: 2 years
Adverse events
time frame: 4 years
Adverse events
time frame: 6 years
Adverse events
time frame: 10 years
Harris hip score
time frame: 4 years
Harris hip score
time frame: 6 years
Harris hip score
time frame: 10 years

Eligibility Criteria

Male or female participants at least 80 years old.

Inclusion Criteria: - Acute displaced femoral neck fracture of hip (Garden classification 3-4) - Independent walker with or without walking aides - Patient willing to participate in the study and give written consent. Exclusion Criteria: - Fracture older than 36 hours before admission - Osteoarthritis in the fractured hip - Rheumatoid arthritis in the fractured hip - Pathological fractures - Contraindication for hip arthroplasty surgery - Not suitable for inclusion for other reasons e.g. substance abuse

Additional Information

Official title Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.
Description Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Danderyd Hospital.