- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07345182
Clinical and Functional Outcomes of Lateral vs Posterior Hemiarthroplasty
Lower Dislocation But Higher Fracture Risk: Posterior vs. Lateral Approaches in Hemiarthroplasty for Femoral Neck Fractures
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Umraniye
-
Istanbul, Umraniye, Turkey (Türkiye), 34764
- Ümraniye Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lateral Approach Group
Patients underwent hemiarthroplasty using the direct lateral surgical approach.
|
Hemiarthroplasty performed using the lateral surgical approach.
|
|
Experimental: Posterior Approach Group
Patients underwent hemiarthroplasty using the posterior surgical approach.
|
Hemiarthroplasty performed using the posterior surgical approach.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prosthetic dislocation rate
Time Frame: Within 12 months postoperatively
|
Incidence of postoperative prosthetic hip dislocation following hemiarthroplasty.
|
Within 12 months postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative periprosthetic femoral fracture rate
Time Frame: During surgery
|
Incidence of intraoperative femoral fractures occurring during hemiarthroplasty.
|
During surgery
|
|
Harris Hip Score (HHS)
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.
|
Preoperative baseline and final follow-up at minimum 12 months postoperatively
|
|
Parker and Palmer Mobility Score (PPMS) change
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.
|
Preoperative baseline and final follow-up at minimum 12 months postoperatively
|
|
One-year mortality
Time Frame: Within 12 months postoperatively
|
All-cause mortality within one year after surgery.
|
Within 12 months postoperatively
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.10.1.TKH.4.34.H.GP.0.01/91
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemiarthroplasty
-
University College Hospital GalwayProf John McDonnell; Prof John LaffeyNot yet recruiting
-
Chuncheon Sacred Heart HospitalCompletedHemiarthroplasty | Arthroplasty, Replacement, Hip
-
Al-Azhar UniversityCompletedTotal Hip Arthroplasty (THA) | Bipolar Hemiarthroplasty | Displaced Fracture Neck Femur | Elderly Active PatientsEgypt
-
Ain Shams UniversityCompletedHip Hemiarthroplasty | Pericapsular Nerve Group Block | Lateral Femoral Cutaneous Nerve Block | Supra-inguinal Fascia Iliaca BlockEgypt
-
Balgrist University HospitalSalzburger LandesklinikenWithdrawn
-
41Hemiverse AGCantonal Hospital of St. GallenTerminated
-
Rijnstate HospitalNoordwest Ziekenhuisgroep; Maxima Medical Center; Jeroen Bosch Ziekenhuis; IsalaEnrolling by invitationHemiarthroplasty | Femoral Neck Fractures | Acetabulum; ProtrusionNetherlands
-
Stryker Trauma and ExtremitiesTerminatedArthroplasty | Hemiarthroplasty | Shoulder PainUnited States
-
Maimonides Medical CenterCompletedFemoral Neck Fractures | Hip Hemiarthroplasty | Intracapsular Fracture of FemurUnited States
-
Fayoum University HospitalCompleted
Clinical Trials on Lateral approach hemiarthroplasty
-
Fujian Provincial HospitalFujian Provincial Hospital Emergency CenterCompleted
-
National and Kapodistrian University of AthensUnknownHip Fractures | Femoral Neck Fractures
-
University of Sao Paulo General HospitalUniversity of Campinas, BrazilUnknown
-
Zonguldak Bulent Ecevit UniversityCompletedUpper Extremity Fracture | Regional Anesthesia | Brachial Plexus Blocks | Perfusion Index | Tissue PerfusionTurkey
-
Istanbul UniversitySisli Hamidiye Etfal Training and Research HospitalCompletedRecurrent Laryngeal Nerve InjuriesTurkey
-
Sahlgrenska University HospitalVastra Gotaland RegionRecruitingMuscle Weakness | Muscle Atrophy | Hip Osteoarthritis | Arthroplasty Complications | Muscle InjurySweden
-
Seoul National University Bundang HospitalCompletedArthroplasty, Replacement, HipKorea, Republic of
-
University of TennesseeUnknownIntra-articular FracturesUnited States
-
Sundsvall HospitalCompletedFemoral Neck FractureSweden