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

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 - HEALTH

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35128

Enrollment

150

Registered

2006-09-11

Start date

2006-10-11

Completion date

Unknown

Last updated

2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

broken hip hip fracture

Interventions

Hemiarthroplasty versus Total Hip Arthroplasty

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome is revision surgery within 2 years of surgery.	—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)