- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06491420
Is There a Role for Hip Arthroscopy in Patients With Femoral Head Fractures?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Femoral head fractures are uncommon but serious injuries often happen because of high-energy trauma, such as traffic accidents or falls from heights. These fractures can result in complications such as avascular necrosis (if associated with hip dislocations), post-traumatic osteoarthritis, heterotopic ossification, and sciatic nerve damage. The management of femoral head fractures is challenging and depends on several variables, such as the fracture pattern, the degree of displacement, the existence of associated injuries, and the patient's age and physical activity.
Traditionally, open reduction and internal fixation (ORIF) or total hip replacement (THR) have been the treatment of femoral head fractures, depending on the extent of the damage and the patient's expectations. However, these procedures have some drawbacks, such as increased blood loss, infection risk, surgical trauma, and implant-related complications. Furthermore, THR might not be appropriate for young, active patients who wish to maintain their natural hip joint, whereas ORIF might not be able to adequately reduce and fixate the fracture fragments, particularly in situations of comminution or impaction.
Nevertheless, hip arthroscopy has surfaced as a minimally invasive alternative for the treatment of selected femoral head fractures. Arthroscopy could be useful in femoral head fractures as it minimizes surgical aggression, in contrast to surgical hip dislocation applied in ORIF, allowing for direct control of fracture reduction, minimizing surgical morbidity, and optimizing early recovery. Hip arthroscopy allows for direct visualization and manipulation of the fracture fragments, as well as the removal of loose bodies and debris from the joint. Hip arthroscopy can also be combined with percutaneous fixation techniques to stabilize the fracture and restore joint congruence. When compared to open surgery, hip arthroscopy may offer several benefits, including shorter recovery times, less discomfort, less blood loss, and better cosmetic results. Arthroscopic-assisted percutaneous fixation has been reported as an effective treatment in selected cases of femoral head fractures.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmed Hazem, MD
- Phone Number: +20 122 330 3789
- Email: azeem@kasralainy.edu.eg
Study Locations
-
-
Manial
-
Cairo, Manial, Egypt, 11956
- Recruiting
- Kasr Al Ainy-Cairo University- Faculty of Medicine
-
Contact:
- Ahmed O Sabry, MBBS
- Phone Number: +201117632926
- Email: sniperrifle22@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with pipkin 1 fractures
Exclusion Criteria:
- any associated pelvic fractures
- severe medical conditions that prevent the patient from undergoing surgery
- delayed presentation after 2 weeks from initial fracture date
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients with pipin 1 fractures fixed with arthroscopy
Accurate portal placement was essential for optimal visualization and safe access to the hip joint.
After reducing the fracture under arthroscopic guidance, a guidewire fixed the fracture a cannulated screw was passed over the wire to fix the fracture. |
the pipkin fracture is fixed with the help of arthroscopy and percutaneous methods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non Arthritic Hip Score
Time Frame: 6 months
|
The Following five questions concern the amount of pain: 1 Walking on a flat surface? 2 Going up or down stairs? 3 At night while in bed? 4 Sitting or lying? 5 tanding upright? the scoring for each question is from 0 to 4
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
- MD-038-2024
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.
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