Femoral Neck FracturesNCT07501741
Comparison of the Direct Anterior Approach (DAA) and the Direct Lateral Approach (DLA) in Patients Treated With Partial Hip Replacement for Femoral Neck Fracture Based on Postoperative Functional Status
An observational study of Femoral Neck Fractures, run by Meir Medical Center.
Trial summary
The goal of this clinical trial is to learn whether the surgical approach used for hemiarthroplasty can improve clinical and functional outcomes in adults with displaced femoral neck fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Neck Fractures
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to May 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult patients undergoing hemiarthroplasty for displaced femoral neck fracture at Meir Medical Center during the study period.
Who may be able to join
- Adults aged 18 years or older Patients undergoing hemiarthroplasty (partial hip replacement) during the study period at Meir Medical Center Ability to provide informed consent for participation in the study
Who cannot join
- Revision surgery performed during the index hospitalization Inability to complete postoperative follow-up Inability to provide informed consent (e.g., dementia or presence of a legal guardian) Pre-injury mobility status of bedbound or wheelchair-bound Polytrauma patients Prior fixation or arthroplasty of the contralateral hip within the previous year
About this study
Official title: Impact of Surgical Approach on Post-Fracture Function: A Prospective Hemiarthroplasty Study
The goal of this clinical trial is to learn whether the surgical approach used for hemiarthroplasty can improve clinical and functional outcomes in adults with displaced femoral neck fractures.
The main questions it aims to answer are:
Read more
- Does the direct anterior approach (DAA) result in superior postoperative functional recovery compared with the direct lateral approach (DLA)?
- Are mortality, complications, hospital utilization, and readmission rates different between the two surgical approaches? Researchers will compare hemiarthroplasty performed using the direct anterior approach to hemiarthroplasty performed using the direct lateral approach to determine whether surgical approach influences postoperative function, complications, and survival.
Participants will:
- Undergo hemiarthroplasty for displaced femoral neck fracture using a randomly assigned surgical approach (DAA or DLA)
- Complete a baseline functional assessment using the Activities of Daily Living (ADL) questionnaire before surgery
- Have perioperative data collected during hospitalization, including laboratory values, operative details, blood loss, transfusions, analgesic use, complications, length of stay, and in-hospital mortality
- Attend follow-up clinic visits at 6 weeks and 3 months after surgery
- Complete postoperative functional assessment using the Harris Hip Score at both follow-up visits
- Have demographic data, complications, readmissions, and mortality monitored through review of electronic medical records
- Conditions
- Femoral Neck Fractures
- Medical subject headings
- Femoral Neck Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (HHS) - Postoperative Functional Outcome at 6 Weeks and 3 Months Following Hemiarthroplasty
Functional outcome will be assessed using the Harris Hip Score (HHS), a validated 100-point scale evaluating pain, function, deformity, and range of motion, collected at 6 weeks and 3 months postoperatively.
Measured: 6 weeks and 3 months post-surgery
Secondary outcomes (1)
Incidence of Treatment-Related Complications Following Hemiarthroplasty
Number of participants with one or more complications- Including intraoperative blood loss, blood transfusions, implant dislocation, implant failure, surgical site infection, and other adverse events.
Measured: During hospitalization and up to 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completionMay 2028 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501741
- Sponsor's protocol ID
- 0046-26-MMC
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Surgical Approach on Post-Fracture Function: A Prospective Hemiarthroplasty Study
- ClinicalTrials.gov ID
- NCT07501741
- Acronym / sponsor ID
- 0046-26-MMC
- Conditions
- Femoral Neck Fractures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 30 Mar 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.
The goal of this clinical trial is to learn whether the surgical approach used for hemiarthroplasty can improve clinical and functional outcomes in adults with displaced femoral neck fractures.
The main questions it aims to answer are:
- Does the direct anterior approach (DAA) result in superior postoperative functional recovery compared with the direct lateral approach (DLA)?
- Are mortality, complications, hospital utilization, and readmission rates different between the two surgical approaches? Researchers will compare hemiarthroplasty performed using the direct anterior approach to hemiarthroplasty performed using the direct lateral approach to determine whether surgical approach influences postoperative function, complications, and survival.
Participants will:
- Undergo hemiarthroplasty for displaced femoral neck fracture using a randomly assigned surgical approach (DAA or DLA)
- Complete a baseline functional assessment using the Activities of Daily Living (ADL) questionnaire before surgery
- Have perioperative data collected during hospitalization, including laboratory values, operative details, blood loss, transfusions, analgesic use, complications, length of stay, and in-hospital mortality
- Attend follow-up clinic visits at 6 weeks and 3 months after surgery
- Complete postoperative functional assessment using the Harris Hip Score at both follow-up visits
- Have demographic data, complications, readmissions, and mortality monitored through review of electronic medical records
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult patients undergoing hemiarthroplasty for displaced femoral neck fracture at Meir Medical Center during the study period.
Key inclusion criteria (1 listed)
- Adults aged 18 years or older Patients undergoing hemiarthroplasty (partial hip replacement) during the study period at Meir Medical Center Ability to provide informed consent for participation in the study
Key exclusion criteria (1 listed)
- Revision surgery performed during the index hospitalization Inability to complete postoperative follow-up Inability to provide informed consent (e.g., dementia or presence of a legal guardian) Pre-injury mobility status of bedbound or wheelchair-bound Polytrauma patients Prior fixation or arthroplasty of the contralateral hip within the previous year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Harris Hip Score (HHS) - Postoperative Functional Outcome at 6 Weeks and 3 Months Following Hemiarthroplasty
Time frame: 6 weeks and 3 months post-surgery
Functional outcome will be assessed using the Harris Hip Score (HHS), a validated 100-point scale evaluating pain, function, deformity, and range of motion, collected at 6 weeks and 3 months postoperatively.
1 secondary outcome
Incidence of Treatment-Related Complications Following Hemiarthroplasty
Time frame: During hospitalization and up to 3 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Neck Fractures, run by Meir Medical Center.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Harris Hip Score (HHS) - Postoperative Functional Outcome at 6 Weeks and 3 Months Following Hemiarthroplasty (time frame: 6 weeks and 3 months post-surgery). 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 30 Mar 2026.