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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral Approach Group | Experimental | Patients underwent hemiarthroplasty using the direct lateral surgical approach. |
|
| Posterior Approach Group | Experimental | Patients underwent hemiarthroplasty using the posterior surgical approach. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Posterior approach hemiarthroplasty | Procedure | Hemiarthroplasty performed using the posterior surgical approach. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic dislocation rate | Incidence of postoperative prosthetic hip dislocation following hemiarthroplasty. | Within 12 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative periprosthetic femoral fracture rate | Incidence of intraoperative femoral fractures occurring during hemiarthroplasty. | During surgery |
| Harris Hip Score (HHS) | The Harris Hip Score is a clinician-based outcome measure ranging from 0 to 100 points, where higher scores indicate better hip function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ümraniye Training and Research Hospital | Istanbul | Umraniye | 34764 | Turkey (Türkiye) |
Individual participant data will not be shared.
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| ID | Term |
|---|---|
| D005265 | Femoral Neck Fractures |
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
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Participants were randomly assigned in a 1:1 ratio to one of two parallel groups to undergo hemiarthroplasty using either the lateral or the posterior surgical approach. Each participant received only the assigned intervention.
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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.
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| Lateral approach hemiarthroplasty | Procedure | Hemiarthroplasty performed using the lateral surgical approach. |
|
| Preoperative baseline and final follow-up at minimum 12 months postoperatively |
| Parker and Palmer Mobility Score (PPMS) change | The Parker and Palmer Mobility Score is a validated mobility assessment scale ranging from 0 to 9 points, where higher scores indicate better mobility. | Preoperative baseline and final follow-up at minimum 12 months postoperatively |
| One-year mortality | All-cause mortality within one year after surgery. | Within 12 months postoperatively |
| D007869 |
| Leg Injuries |