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

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

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.

Study Overview

• Status: Completed
• Conditions: Femoral Neck Fracture
• Intervention / Treatment: Procedure: Internal fixation; Procedure: Total hip arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 182 88
    • Danderyd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Internal fixation; Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.	Procedure: Internal fixation; Two cannulated screws are placed under x-ray guidance
Active Comparator: Total hip replacement; Displaced femoral neck fracture treated with total hip replacement through a posterior approach.	Procedure: Total hip arthroplasty; A total hip arthroplasty is performed through a standard posterior approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Investigators: Principal Investigator: Olof Sköldenberg, MD, PhD, Danderyd Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 1990
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: April 28, 2011
• First Submitted That Met QC Criteria: April 28, 2011
• First Posted (Estimate): April 29, 2011

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 23, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: total hip arthroplasty; femoral neck fracture; internal fixation
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: 19902010