Lower Dislocation But Higher Fracture Risk: Posterior vs. Lateral Approaches in Hemiarthroplasty for Femoral Neck Fractures
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Umraniye Education and Research Hospital
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Prosthetic dislocation rate
Overview
Brief Summary
This prospective, single-center, randomized clinical trial compared the clinical and functional outcomes of hemiarthroplasty performed via lateral versus posterior surgical approaches in elderly patients with displaced intracapsular femoral neck fractures. The primary objective was to compare prosthetic dislocation and intraoperative femoral fracture rates between the two approaches. Secondary outcomes included functional scores, radiological parameters, complications, and mortality.
Detailed Description
This study is a prospective, single-center, randomized clinical trial designed to compare the clinical, functional, and radiological outcomes of hemiarthroplasty performed via lateral and posterior surgical approaches in elderly patients with displaced intracapsular femoral neck fractures.
Between March 2016 and June 2019, eligible patients were randomized in a 1:1 ratio to undergo hemiarthroplasty using either the lateral or posterior approach. Randomization was performed using a computer-generated sequence. All procedures were performed or supervised by experienced orthopedic surgeons following standardized surgical and postoperative protocols.
Clinical parameters, perioperative data, and radiological indices including cortical index, Singh index, and Dorr classification were recorded. Functional outcomes were assessed using the Parker and Palmer Mobility Score (PPMS) and the Harris Hip Score (HHS). Patients were followed for a minimum of 12 months.
The primary outcome measure was the prosthetic dislocation rate within 12 months postoperatively. Secondary outcomes included intraoperative periprosthetic femoral fracture rate, functional scores, complications, and mortality. The study was conducted in accordance with the principles of the Declaration of Helsinki, with approval obtained from the local ethics committee, and written informed consent was obtained from all participants or their legal representatives.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
This study was conducted as an open-label trial. Due to the nature of the surgical interventions, blinding of surgeons and participants was not feasible.
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 60 years or older
- •Displaced intracapsular femoral neck fracture
- •Treated with hemiarthroplasty
- •Ability to provide informed consent by the patient or a legal representative
Exclusion Criteria
- •Pathological femoral neck fractures
- •Previous surgery on the affected hip
- •Polytrauma patients
- •Periprosthetic fractures
Arms & Interventions
Lateral Approach Group
Patients underwent hemiarthroplasty using the direct lateral surgical approach.
Intervention: Lateral approach hemiarthroplasty (Procedure)
Posterior Approach Group
Patients underwent hemiarthroplasty using the posterior surgical approach.
Intervention: Posterior approach hemiarthroplasty (Procedure)
Outcomes
Primary Outcomes
Prosthetic dislocation rate
Time Frame: Within 12 months postoperatively
Incidence of postoperative prosthetic hip dislocation following hemiarthroplasty.
Secondary Outcomes
- Intraoperative periprosthetic femoral fracture rate(During surgery)
- Harris Hip Score (HHS)(Preoperative baseline and final follow-up at minimum 12 months postoperatively)
- Parker and Palmer Mobility Score (PPMS) change(Preoperative baseline and final follow-up at minimum 12 months postoperatively)
- One-year mortality(Within 12 months postoperatively)
Investigators
Yusuf Bayram
Orthopaedic Surgeon
Umraniye Education and Research Hospital