Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck

Femoral Neck Fracture Clinical Trial

Official title:

Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck. A Randomized, Controlled Trial With a Seventeen Year Follow-up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344772
• Other study ID #: 19902010
• Status: Completed
• Phase: N/A
• First received: April 28, 2011
• Last updated: November 23, 2012
• Start date: February 1990
• Est. completion date: June 2011

Study information

• Verified date: November 2012
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Acute displaced femoral neck fracture Garden III or IV,

• Age over 65 years,

• Admission from their own home,

• No concurrent joint disease or previous fracture in the lower extremities,

• Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),

• Harris hip score of 100

• Acceptance from the patient to participate in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Internal fixation
Two cannulated screws are placed under x-ray guidance
• Total hip arthroplasty
A total hip arthroplasty is performed through a standard posterior approach

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris hip score	HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function.	17 years	No
Secondary	Reoperations and complications	IF group: nonunion, osteonecrosis, deep infection or fracture in the vicinity of the screws. Protruding screws or extraction of the screws when the fracture was healed was not defined as a complication.; THR group: radiographic signs of loosening of the femoral- or acetabular component, dislocation, periprosthetic fracture or deep infection	17 years	No