Femoral Neck FractureNCT05171140
Influence of the Spatial Distribution of Hollow Screws on the Blood Supply and Prognosis of Femoral Neck Fractures
A study testing Triangular Nail Placement of Femoral Neck in people with Femoral Neck Fracture, run by RenJi Hospital at 1 site in China.
Trial summary
Femoral neck fracture is a common type of fracture in the elderly. For those without significant displacement (Garden I, II), more hip-preserving treatment strategies are adopted. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Femoral Neck Fracture
- What is being tested?
- Triangular Nail Placement of Femoral Neck
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Aug 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A new initial intracapsular fracture of the femoral neck;
- Garden classification I or II;
- Accept closed reduction robot-assisted hollow nail surgery;
- ASA score 1-2, can tolerate anesthesia;
- Age 60-80 years old (inclusive);
- Able to fully understand and voluntarily sign informed consent.
Who cannot join
- Old or pathological fractures;
- Patients with acetabular fracture;
- Those who have general conditions or accompanying diseases that make it difficult for people to tolerate surgery, such as: coagulation dysfunction, or heart, liver, and kidney dysfunction;
- Severe infections systemically or locally;
- Those who refuse to sign informed consent;
- In any case, if the researcher believes that the patient is not suitable for this treatment or there are other factors that affect the efficacy of the observation of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality, 200127
Ping Huang, +8613916121692, 8813@renji.com
About this study
Official title: Influence of Different Spatial Distribution of Hollow Screws on Blood Supply and Prognosis of Femoral Neck Fractures in the Elderly
Femoral neck fracture is a common type of fracture in the elderly. For those without significant displacement (Garden I, II), more hip-preserving treatment strategies are adopted. The classic parallel hollow screw internal fixation for hip-preserving treatment is based on the sliding compression theory, and a clinical debate has gradually emerged, that is, the positive triangle And the two different spatial distribution methods of hollow nails and inverted triangle, which one is better. In addition, the distribution of hollow nails in actual operations is difficult to achieve a standard triangular distribution, and the damage to the epiphyseal vessels in the femoral head caused by repeated drilling of the guide needle cannot always be ignored. The relationship between the distribution and injury of blood vessels in the femoral head and the spatial distribution of hollow screws on the prognosis of head necrosis of non-displaced femoral neck fractures in the elderly is worth studying. This topic is based on the three advantages of TianJi orthopedic robots used in the elderly femoral neck fracture hollow nail hip-saving surgery: 1.standardized triangular nail placement with strong repeatability; 2. precise nail placement to reduce the risk of screw penetration; 3. limited guide pins The number of drill holes is to rule out repeated drill holes that damage the blood vessels in the femoral head. The preoperative and postoperative vascular injury in the femoral head (enhanced MRI of the femoral head) was compared to assess the prognosis of patients, and to clarify the influence of the spatial distribution of hollow screws on the blood supply and prognosis of the femoral neck fracture in the elderly.
Read the detailed description
the investigators choose 60-80-year-old Garden I or II patients with initial fractures. Hollow nails are the first choice for treatment of these patients. However, the spatial arrangement of hollow nails, local blood supply, and biomechanical properties have a greater impact on the prognosis of fractures. , There are still some controversies, which are also the current research hotspots. Our research conclusions may increase the success rate of hip preservation and will guide the treatment of these patients. This study is based on the precise placement of nails by the Dimensity orthopedic robot, and compares the vascular injury of the femoral head before and after the nail placement (femoral head enhanced MRI) to assess the prognosis of the patient. The influence of blood supply and prognosis of femoral neck fracture in the elderly.
- Conditions
- Femoral Neck Fracture
- Being tested
- Triangular Nail Placement of Femoral Neck
- Keywords
- Femoral Neck Fracture, Robot assisted, Blood supply of femoral head
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triangular Nail Placement of Femoral NeckProcedure or surgery
Triangular Nail Placement of Femoral Neck in arm A Femoral Neck Inverted Triangle Nail Surgery in arm B
| Study group | Role | What they receive |
|---|---|---|
| Hollow nails are arranged in a triangle | Experimental | Hollow nails are arranged in a triangle Receives: Procedure: Triangular Nail Placement of Femoral Neck |
| Hollow nail inverted triangle arrangement | Experimental | Hollow nail inverted triangle arrangement Receives: Procedure: Triangular Nail Placement of Femoral Neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of hip joint function at 6 months
Harris score
Measured: 6 months after surgery
comparison of hip joint function at 12 months
Harris score
Measured: 12 months after surgery
Imaging evaluation of the vascular condition of the femoral head epiphysis before surgery
Imaging evaluation of the vascular condition of the femoral head epiphysis
Measured: One day before surgery
Imaging evaluation of the vascular condition of the femoral head epiphysis after surgery
Imaging evaluation of the vascular condition of the femoral head epiphysis
Measured: 2 months after surgery
Secondary outcomes (2)
Intraoperative indicators-surgical blood loss
surgical blood loss（ml）
Measured: Intraoperative
Intraoperative indicators-operation time
operation time（minute）
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start1 Sep 2020
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FractureStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ping Huang, Master, Principal investigator, Shanghai Jiaotong University School of Medical Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171140
- Sponsor's protocol ID
- 2020YJZX0112
- Status last verified
- Nov 2021
- First submitted
- 22 Nov 2021
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Spatial Distribution of Hollow Screws on Blood Supply and Prognosis of Femoral Neck Fractures in the Elderly
- ClinicalTrials.gov ID
- NCT05171140
- Acronym / sponsor ID
- 2020YJZX0112
- Conditions
- Femoral Neck Fracture
- Keywords
- Femoral Neck Fracture, Robot assisted, Blood supply of femoral head
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 28 Dec 2021 (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 neck fracture is a common type of fracture in the elderly. For those without significant displacement (Garden I, II), more hip-preserving treatment strategies are adopted. The classic parallel hollow screw internal fixation for hip-preserving treatment is based on the sliding compression theory, and a clinical debate has gradually emerged, that is, the positive triangle And the two different spatial distribution methods of hollow nails and inverted triangle, which one is better. In addition, the distribution of hollow nails in actual operations is difficult to achieve a standard triangular distribution, and the damage to the epiphyseal vessels in the femoral head caused by repeated drilling of the guide needle cannot always be ignored. The relationship between the distribution and injury of blood vessels in the femoral head and the spatial distribution of hollow screws on the prognosis of head necrosis of non-displaced femoral neck fractures in the elderly is worth studying. This topic is based on the three advantages of TianJi orthopedic robots used in the elderly femoral neck fracture hollow nail hip-saving surgery: 1.standardized triangular nail placement with strong repeatability; 2. precise nail placement to reduce the risk of screw penetration; 3. limited guide pins The number of drill holes is to rule out repeated drill holes that damage the blood vessels in the femoral head. The preoperative and postoperative vascular injury in the femoral head (enhanced MRI of the femoral head) was compared to assess the prognosis of patients, and to clarify the influence of the spatial distribution of hollow screws on the blood supply and prognosis of the femoral neck fracture in the elderly.
Detailed description
the investigators choose 60-80-year-old Garden I or II patients with initial fractures. Hollow nails are the first choice for treatment of these patients. However, the spatial arrangement of hollow nails, local blood supply, and biomechanical properties have a greater impact on the prognosis of fractures. , There are still some controversies, which are also the current research hotspots. Our research conclusions may increase the success rate of hip preservation and will guide the treatment of these patients. This study is based on the precise placement of nails by the Dimensity orthopedic robot, and compares the vascular injury of the femoral head before and after the nail placement (femoral head enhanced MRI) to assess the prognosis of the patient. The influence of blood supply and prognosis of femoral neck fracture in the elderly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hollow nails are arranged in a triangle | Experimental | Procedure: Triangular Nail Placement of Femoral NeckHollow nails are arranged in a triangle |
| Hollow nail inverted triangle arrangement | Experimental | Procedure: Triangular Nail Placement of Femoral NeckHollow nail inverted triangle arrangement |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A new initial intracapsular fracture of the femoral neck;
- Garden classification I or II;
- Accept closed reduction robot-assisted hollow nail surgery;
- ASA score 1-2, can tolerate anesthesia;
- Age 60-80 years old (inclusive);
Key exclusion criteria (6 listed)
- Old or pathological fractures;
- Patients with acetabular fracture;
- Those who have general conditions or accompanying diseases that make it difficult for people to tolerate surgery, such as: coagulation dysfunction, or heart, liver, and kidney dysfunction;
- Severe infections systemically or locally;
- Those who refuse to sign informed consent;
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 |
|---|---|---|
| Triangular Nail Placement of Femoral NeckTriangular Nail Placement of Femoral Neck in arm A Femoral Neck Inverted Triangle Nail Surgery in arm B | Procedure or surgery | Hollow nail inverted triangle arrangement, Hollow nails are arranged in a triangle |
Primary outcome
comparison of hip joint function at 6 months
Time frame: 6 months after surgery
Harris score
comparison of hip joint function at 12 months
Time frame: 12 months after surgery
Harris score
Imaging evaluation of the vascular condition of the femoral head epiphysis before surgery
Time frame: One day before surgery
Imaging evaluation of the vascular condition of the femoral head epiphysis
Imaging evaluation of the vascular condition of the femoral head epiphysis after surgery
Time frame: 2 months after surgery
Imaging evaluation of the vascular condition of the femoral head epiphysis
2 secondary outcomes
Intraoperative indicators-surgical blood loss
Time frame: Intraoperative
Intraoperative indicators-operation time
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Ping Huang, Master principal investigator
Shanghai Jiaotong University School of Medical Renji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triangular Nail Placement of Femoral Neck in people with Femoral Neck Fracture, run by RenJi Hospital at 1 site in China.
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 6 inclusion and 6 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 28 Dec 2021. 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 China. 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 Ping Huang, Master (+86 13916121692, 8813@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of hip joint function at 6 months (time frame: 6 months after surgery). The study lists 4 primary outcomes in all. 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 28 Dec 2021.