Femoral Neck FracturesNCT07345182
Clinical and Functional Outcomes of Lateral vs Posterior Hemiarthroplasty
A study testing Posterior approach hemiarthroplasty and Lateral approach hemiarthroplasty in people with Femoral Neck Fractures and Hip Fractures, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Femoral Neck Fractures, Hip Fractures, Hemiarthroplasty
- What is being tested?
- Posterior approach hemiarthroplasty and Lateral approach hemiarthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2016to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pathological femoral neck fractures
- Previous surgery on the affected hip
- Polytrauma patients
- Periprosthetic fractures
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ümraniye Training and Research Hospital
Istanbul, Umraniye, 34764
About this study
Official title: Lower Dislocation But Higher Fracture Risk: Posterior vs. Lateral Approaches in Hemiarthroplasty for Femoral Neck Fractures
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.
Read the 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.
- Conditions
- Femoral Neck Fractures, Hip Fractures, Hemiarthroplasty
- Being tested
- Posterior approach hemiarthroplasty, Lateral approach hemiarthroplasty
- Keywords
- Lateral Hemiarthroplasty, Posterior Hemiarthroplasty, Surgical Approach, Functional Outcome, Harris Hip Score, Parker and Palmer Mobility Score
- Medical subject headings
- Femoral Neck Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior approach hemiarthroplastyProcedure or surgery
Hemiarthroplasty performed using the posterior surgical approach.
Lateral approach hemiarthroplastyProcedure or surgery
Hemiarthroplasty performed using the lateral surgical approach.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Approach Group | Experimental | Patients underwent hemiarthroplasty using the direct lateral surgical approach. Receives: Procedure: Lateral approach hemiarthroplasty |
| Posterior Approach Group | Experimental | Patients underwent hemiarthroplasty using the posterior surgical approach. Receives: Procedure: Posterior approach hemiarthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic dislocation rate
Incidence of postoperative prosthetic hip dislocation following hemiarthroplasty.
Measured: Within 12 months postoperatively
Secondary outcomes (4)
Intraoperative periprosthetic femoral fracture rate
Incidence of intraoperative femoral fractures occurring during hemiarthroplasty.
Measured: 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.
Measured: 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.
Measured: Preoperative baseline and final follow-up at minimum 12 months postoperatively
One-year mortality
All-cause mortality within one year after surgery.
Measured: Within 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Mar 2016
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Bayram, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345182
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/91
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower Dislocation But Higher Fracture Risk: Posterior vs. Lateral Approaches in Hemiarthroplasty for Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT07345182
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/91
- Conditions
- Femoral Neck Fractures, Hip Fractures, Hemiarthroplasty
- Keywords
- Lateral Hemiarthroplasty, Posterior Hemiarthroplasty, Surgical Approach, Functional Outcome, Harris Hip Score, Parker and Palmer Mobility Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lateral Approach Group | Experimental | Procedure: Lateral approach hemiarthroplastyPatients underwent hemiarthroplasty using the direct lateral surgical approach. |
| Posterior Approach Group | Experimental | Procedure: Posterior approach hemiarthroplastyPatients underwent hemiarthroplasty using the posterior surgical approach. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Pathological femoral neck fractures
- Previous surgery on the affected hip
- Polytrauma patients
- Periprosthetic fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior approach hemiarthroplastyHemiarthroplasty performed using the posterior surgical approach. | Procedure or surgery | Posterior Approach Group |
| Lateral approach hemiarthroplastyHemiarthroplasty performed using the lateral surgical approach. | Procedure or surgery | Lateral Approach Group |
Primary outcome
Prosthetic dislocation rate
Time frame: Within 12 months postoperatively
Incidence of postoperative prosthetic hip dislocation following hemiarthroplasty.
4 secondary outcomes
Intraoperative periprosthetic femoral fracture rate
Time frame: During surgery
Harris Hip Score (HHS)
Time frame: 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
One-year mortality
Time frame: Within 12 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior approach hemiarthroplasty and Lateral approach hemiarthroplasty in people with Femoral Neck Fractures and Hip Fractures, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic dislocation rate (time frame: Within 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.