- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07501741
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
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:
- 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 Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 weeks and 3 months post-surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Treatment-Related Complications Following Hemiarthroplasty
Time Frame: During hospitalization and up to 3 months post-surgery
|
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.
|
During hospitalization and up to 3 months post-surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0046-26-MMC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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