Ümraniye Training and Research Hospital
Istanbul, Umraniye, 34764, Turkey (Türkiye)
NCT Number: NCT07345182
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.
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Notify Me60 year and older
All sexes
Interventional
Not applicable
Istanbul, Umraniye, 34764, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hemiarthroplasty performed using the posterior surgical approach.
Hemiarthroplasty performed using the lateral surgical approach.
Time frame: Within 12 months postoperatively
Incidence of postoperative prosthetic hip dislocation following hemiarthroplasty.
Time frame: During surgery
Incidence of intraoperative femoral fractures occurring during hemiarthroplasty.
Time frame: Preoperative baseline and final follow-up at minimum 12 months postoperatively
The Harris Hip Score is a clinician-based outcome measure ranging from 0 to 100 points, where higher scores indicate better hip function.
Time frame: Preoperative baseline and final follow-up at minimum 12 months postoperatively
The Parker and Palmer Mobility Score is a validated mobility assessment scale ranging from 0 to 9 points, where higher scores indicate better mobility.
Time frame: Within 12 months postoperatively
All-cause mortality within one year after surgery.
Umraniye Education and Research Hospital
Other Gov
Lower Dislocation But Higher Fracture Risk: Posterior vs. Lateral Approaches in Hemiarthroplasty for Femoral Neck Fractures
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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