Femur Head FractureNCT06491420
Is There a Role for Hip Arthroscopy in Patients With Femoral Head Fractures?
A study testing fixation with arthroscopy in people with Femur Head Fracture and Arthroscopy, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Femoral head fractures, often caused by high-energy trauma, pose significant challenges due to complications like avascular necrosis, post-traumatic osteoarthritis, and sciatic nerve damage. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Femur Head Fracture, Arthroscopy
- What is being tested?
- fixation with arthroscopy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Dec 2024
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with pipkin 1 fractures
Who cannot join
- any associated pelvic fractures
- severe medical conditions that prevent the patient from undergoing surgery
- delayed presentation after 2 weeks from initial fracture date
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Al Ainy-Cairo University- Faculty of Medicine
Cairo, Manial, 11956
Ahmed O Sabry, MBBS, +201117632926, sniperrifle22@gmail.com
About this study
Femoral head fractures, often caused by high-energy trauma, pose significant challenges due to complications like avascular necrosis, post-traumatic osteoarthritis, and sciatic nerve damage. While traditionally treated with open reduction and internal fixation (ORIF) or total hip replacement (THR), hip arthroscopy has emerged as a minimally invasive alternative that reduces surgical trauma, offers direct fracture visualization and manipulation, and may result in shorter recovery times and fewer complications.
Read the 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.
- Conditions
- Femur Head Fracture, Arthroscopy
- Being tested
- fixation with arthroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fixation with arthroscopyOther
the pipkin fracture is fixed with the help of arthroscopy and percutaneous methods.
| Study group | Role | What they receive |
|---|---|---|
| Patients with pipin 1 fractures fixed with arthroscopy | Experimental | Accurate portal placement was essential for optimal visualization and safe access to the hip joint.
* The anterolateral, anterior, and distal lateral accessory portals were utilized for arthroscopic labral repair.
* The anterolateral portal was placed approximately 1-2 cm superior to the tip of the greater trochanter and 1-2 cm anterior, at an angle of 15° to 20° relative to the floor.
* The anterior portal was established for visualization of the posterior-superior capsule, posterior-superior labrum, posterior recess, femoral head, ligamentum teres, and other structures.
* The distal lateral accessory portal was placed after traction was released and the operative knee was flexed to 45°.
After reducing the fracture under arthroscopic guidance, a guidewire fixed the fracture a cannulated screw was passed over the wire to fix the fracture. Receives: Other: fixation with arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non Arthritic Hip Score
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 Jan 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femur Head FractureStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- A single limb interventional study where all cases presenting with pipkin 1 fractures are treated with arthroscopy
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Omar Sabry, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491420
- Sponsor's protocol ID
- MD-038-2024
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The author will share it upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There a Role for Hip Arthroscopy in Patients With Femoral Head Fractures?
- ClinicalTrials.gov ID
- NCT06491420
- Acronym / sponsor ID
- MD-038-2024
- Conditions
- Femur Head Fracture, Arthroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 9 Jul 2024 (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.
Femoral head fractures, often caused by high-energy trauma, pose significant challenges due to complications like avascular necrosis, post-traumatic osteoarthritis, and sciatic nerve damage. While traditionally treated with open reduction and internal fixation (ORIF) or total hip replacement (THR), hip arthroscopy has emerged as a minimally invasive alternative that reduces surgical trauma, offers direct fracture visualization and manipulation, and may result in shorter recovery times and fewer complications.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single limb interventional study where all cases presenting with pipkin 1 fractures are treated with arthroscopy
| Arm | Type | Receives |
|---|---|---|
| Patients with pipin 1 fractures fixed with arthroscopy | Experimental | Other: fixation with arthroscopyAccurate portal placement was essential for optimal visualization and safe access to the hip joint. * The anterolateral, anterior, and distal lateral accessory portals were utilized for arthroscopic labral repair. * The anterolateral portal was placed approximately 1-2 cm superior to the tip of the greater trochanter and 1-2 cm anterior, at an angle of 15° to 20° relative to the floor. * The anterior portal was established for visualization of the posterior-superior capsule, posterior-superior labrum, posterior recess, femoral head, ligamentum teres, and other structures. * The distal lateral accessory portal was placed after traction was released and the operative knee was flexed to 45°. After reducing the fracture under arthroscopic guidance, a guidewire fixed the fracture a cannulated screw was passed over the wire to fix the fracture. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with pipkin 1 fractures
Key exclusion criteria (3 listed)
- any associated pelvic fractures
- severe medical conditions that prevent the patient from undergoing surgery
- delayed presentation after 2 weeks from initial fracture date
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 |
|---|---|---|
| fixation with arthroscopythe pipkin fracture is fixed with the help of arthroscopy and percutaneous methods. | Other | Patients with pipin 1 fractures fixed with arthroscopy |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: Undecided. The author will share it upon reasonable request
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fixation with arthroscopy in people with Femur Head Fracture and Arthroscopy, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 9 Jul 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hazem, MD (+20 122 330 3789, azeem@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non Arthritic Hip Score (time frame: 6 months). 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 9 Jul 2024.