N/A
N=1,495
Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Secondary Procedures and Quality of Life in Adults With Displaced Hip Fractures
Hip Fractures · Femoral Neck Fractures
Bottom Line
View on ClinicalTrials.gov: NCT00556842 ↗Enrolled (actual)
1,495
Serious AEs
39.2%
Results posted
Jul 2020
Primary outcome: Primary: Number of Participants With Revision Surgery — 57; 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Total hip arthroplasty (Device); Hemi-arthroplasty (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- McMaster University
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Revision Surgery |
57; 60 | — |
| SECONDARY Hip Function and Pain |
14.29; 17.22; 1.65; 2.21; 1.05; 1.22 | — |
| SECONDARY Number of Participants With Functional Mobility Problems |
210; 206 | — |
| SECONDARY Health-Related Quality of Life (SF-12) |
41.89; 41.27; 54.03; 51.36 | — |
| SECONDARY Health-Related Quality of Life (EQ-5D) |
0.82; 0.77; 72.26; 70.84 | — |
| SECONDARY Complications, Including Mortality, Dislocation, Infection, Femoral Fracture, Deep Venous Thrombosis, and Prosthesis Loosening |
103; 95; 300; 265; 132; 118 | — |
Summary
Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. By the year 2040, the annual healthcare costs associated with hip fractures are expected to reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a displaced femoral neck fracture, is often treated with a hip replacement surgery. Patients undergoing a hip replacement may receive either a total hip replacement, in which the head of the femur and the hip joint socket are replaced, or a partial hip replacement, in which only the head of the femur is replaced. This study will compare the two different hip replacement procedures to determine which one results in better outcomes after surgery in adults aged 50 and older.
Eligibility Criteria
Inclusion Criteria
- Adult men or women aged 50 years and old (with no upper age limit)
- Fracture of the femoral neck, as confirmed with either anteroposterior or lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI)
- Displaced fracture that is not, in the judgment of the attending surgeon, optimally managed by reduction and internal fixation
- Operative treatment is planned within 72 hours of the patient being medically cleared for surgery
- Patient was ambulatory prior to the fracture, though they may have used an aid such as a cane or a walker
- Anticipated medical optimization for arthroplasty of the hip
- Provision of informed consent by patient or proxy
- Low energy fracture (defined as a fall from standing height), with no other trauma
- Assurance from site 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
- Not suitable for hemi-arthroplasty (i.e., inflammatory arthritis, rheumatoid arthritis, pathologic fractures (secondary to cancer), or severe osteoarthritis of the hip)
- Associated major injuries of the lower extremity (e.g., 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)
- Retained hardware around the affected hip that will interfere with arthroplasty
- Infection around the hip (soft tissue or bone)
- Bone metabolism disorder except osteoporosis (e.g., Paget's disease, renal osteodystrophy, osteomalacia)
- Patients with a previous history of frank dementia that would interfere with the assessment of primary outcome (e.g., secondary procedures at 2 years).
- Likely problems, in the judgment of the investigators, with maintaining follow-up (e.g., no fixed address, plans to move out of town in the next year, or intellectually challenged and without adequate family support)
- Enrolled in another ongoing drug or surgical intervention trial
- Patients whose fracture occurred as a result of violence.
Data sourced from ClinicalTrials.gov (NCT00556842). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.