HEALTH

Overview

Status: Enrolling by invitation
Keywords: randomized , hip fractures , prospective
IRB Number: 00067547
Specialty: Orthopaedic Surgery, Orthopaedic Surgery
Sub Specialties: Orthopaedic Trauma

Brief Summary

The primary objective is to assess the impact of total hip arthroplasty versus hemi-arthroplasty (i.e., bipolar or modular unipolar) on rates of revision surgery at 2 years in individuals with displaced femoral neck fractures. 

Secondary objectives are:

1. To examine the effect of total hip arthroplasty versus hemi-arthroplasty on health-related quality of life (Short Form-12, SF-12), functional outcomes and mobility (Western Ontario McMaster Osteoarthritis Index, WOMAC, and Timed Up and Go Test, TUG), and health outcome measures (EuroQol-5 Dimensions, EQ-5D).

2. To evaluate the effect of total hip arthroplasty versus hemi-arthroplasty on mortality, hip dislocation, hip instability, infection, peri-prosthetic fracture, implant breakage, implant loosening, and intractable pain due to wear of the acetabulum.

Principal Investigator: Erik Kubiak
Department: Orthopedic Surgery
Co Investigator: Erik Kubiak

Contact Information

Name:Mikayla Lyman
Phone: 801-583-3366
Email: mikayla.lyman@hsc.utah.edu

Inclusion Criteria

1. Adult men or women aged 50 years and older (with no upper age limit). 

2. Fracture of the femoral neck confirmed with either anteroposterior or lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI). 

3. Displaced fracture that is not, in the judgment of the attending surgeon, optimally managed by reduction and internal fixation. 

4. Operative treatment within 3 days (i.e. 72 hours) of the patient being medically cleared for surgery. 

5. Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker. 

6. Anticipated medical optimization for arthroplasty of the hip. 

7. Provision of informed consent by patient or proxy. 

8. Low energy fracture (defined as a fall from standing height). 

9. No other major trauma (defined as an Injury Severity Score <17*). 

10. Assurance that surgeons with expertise in both total hip arthroplasty and hemi-arthroplasty are available to perform surgery. Note: Surgeons do not need to be experts in both techniques. 

Exclusion Criteria

 

1. Patient not suitable for hemi-arthroplasty (e.g. inflammatory arthritis, rheumatoid arthritis, pathologic fracture (secondary to cancer), 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 that will interfere with arthroplasty. 

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. Patients with a previous history of frank dementia that would interfere with assessment of the primary outcome (i.e., revision surgery at 2 years). 

7. Likely problems, in the judgment of the investigators, with maintaining follow-up (i.e., patients with no fixed address, report a plan to move out of town, or intellectually challenged patients without adequate family support). 

8. Patients whose fracture occurred as a result of an act of violence.