Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH): A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients with Displaced Femoral Neck Fractures

Completed

Conditions: broken hip
hip fracture
10017322

Registration Number: NL-OMON35128

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

1. Adult men or women aged 60 years and older (with no upper age limit).
2. Fracture of the femoral neck confirmed with either anteroposterior or lateral hip radiographs.
3. Displaced fracture in the judgment of the attending surgeon.
4. Operative treatment within 3 days (i.e., 72 hours) of presenting to the emergency room.
5. Provision of informed consent by patient or legal guardian.
6. No other major trauma to ipsi- or contralateral extremity.

Exclusion Criteria

1. Patient not suitable for hemi-arthroplasty (i.e., inflammatory arthritis, rheumatoid arthritis, pathologic fractures, or severe osteoarthritis of the hip).
2. Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
3. Retained hardware around the affected hip.
4. Infection around the hip (soft tissue or bone).
5. Patients with a disorder of bone metabolism other than osteoporosis (i.e., Paget*s disease, renal osteodystrophy, osteomalacia).
6. Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
7. Patients with Parkinson*s disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is revision surgery within 2 years of surgery. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes include health-related quality of life (Short Form-12,<br /><br>SF-12), functional outcomes (Western Ontario McMaster Osteoarthritis Index,<br /><br>WOMAC), and health utility (Health Utilities Index Mark III, HUI3). We will<br /><br>independently adjudicate revision surgery rates at regular intervals up to 2<br /><br>years. </p><br>