Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly

Not Applicable

• Conditions: Femoral Neck Fractures
• Interventions: Device: Cemented total hip arthroplasty; Device: Cemented hemiarthroplasty

• Registration Number: NCT02246335
• Lead Sponsor: Danderyd Hospital

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-19
• Study First Posted: 2014-09-22
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-29
• Last Update Posted: 2016-08-30
• Primary Completion: 2016-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Cemented total hip arthroplasty	Total hip arthroplasty
Control group	Cemented hemiarthroplasty	Hemiarthroplasty

Primary Outcome Measures

Name	Time	Method
Harris hip score	2 years	The hip specific outcome score Harris hip score at 2 years will be the main outcome variable

Secondary Outcome Measures

Name	Time	Method
EQ-5D	10 years	Health-related quality of life at 10 years
Adverse events	10 years	All hip related adverse events at 10 years
Harris hip score	10 years	Harris hip score at 10 years

Trial Locations

Locations (1)

Orthopaedic department, Danderyd Hospital; 🇸🇪 Stockholm, Sweden