Fracture of Neck of FemurNCT06713018
Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures
A study testing Three cannulated compression screws by navigation system and Traditional three cannulated compression screws in people with Fracture of Neck of Femur, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures. Participants will: Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Neck of Femur
- What is being tested?
- Three cannulated compression screws by navigation system and Traditional three cannulated compression screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2024to 31 Oct 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years old, gender is not limited;
- Patients diagnosed with femoral neck fracture;
- Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
- The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.
Who cannot join
- Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit;
- The patient is known to have a history of allergy to one or more implanted materials;
- Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
- Active infection of the hip joint or other parts of the body is determined by the investigator;
- Diagnosed as metabolic bone disease, radiation bone disease, etc.;
- Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
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- have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
- The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
- Other conditions deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chinese PLA General Hospital
Beijing
Meng Li, +8615334508850, limeng1@301hospital.com.cn
About this study
Official title: Prospective, Multicenter, Randomized Controlled Clinical Study of Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures
The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures.
Participants will:
- Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures.
- Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.
- Conditions
- Fracture of Neck of Femur
- Being tested
- Three cannulated compression screws by navigation system, Traditional three cannulated compression screws
- Keywords
- orthopedic intelligent navigation system
- 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.
Three cannulated compression screws by navigation systemProcedure or surgery
Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system
Traditional three cannulated compression screwsProcedure or surgery
Patients with femoral neck fractures treated with traditional three cannulated compression screws
| Study group | Role | What they receive |
|---|---|---|
| Three cannulated compression screws by navigation system | Experimental | Not described Receives: Procedure: Three cannulated compression screws by navigation system |
| Traditional three cannulated compression screws | Placebo comparator | Not described Receives: Procedure: Traditional three cannulated compression screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perspective frequency
Document the total number of intraoperative fluoroscopy sessions taken during surgery, including each anteroposterior and lateral fluoroscopic image
Measured: 1 day
Secondary outcomes (9)
Neck shaft angle
Measured: 1 year
Guide needle implantation effect
For the group treated with three hollow compression screws, the effect of the implantation of guide pins is categorized into three parallel pins, two parallel pins, and mutually non-parallel pins, with measurements taken during the surgery.
Measured: 1 day
Fluoroscopy times of needle implantation
Measured: 1 day
Operation time
Measured: 1 day
Operative blood loss
Measured: 1 day
Fracture union
Postoperative follow-up observation is conducted for all patients, with anteroposterior and lateral hip X-rays taken at the 1st, 3rd, 6th, and 12th postoperative months. X ray and CT scans are reviewed at the 1st and 3rd postoperative months to observe the stability of the implanted internal fixation, the disappearance of the fracture line, and whether there is displacement of the fracture ends.
Measured: 1 year
Zarit Burden Interview score
The Zarit Burden Interview (ZBI) is a commonly used assessment tool designed to quantify the psychological and emotional burden experienced by caregivers who provide care for individuals with cognitive or functional impairments. Developed by Zarit and colleagues, the scale consists of 22 items that cover various aspects of caregiver burden, such as time pressure, emotional strain, and social isolation. The scoring ranges from 0 to 88, with higher scores indicating a greater level of caregiving burden. This tool aids healthcare professionals in identifying the psychological stress faced by caregivers and provides appropriate support and interventions to improve their mental health and quality of life.
Measured: 1 year
Harris score
The Harris Score (Harris Hip Score, HHS) is a widely used scale for evaluating hip joint function and patient quality of life, often applied to assess the outcomes of hip replacement surgery or other treatments for hip joint diseases. It covers four main aspects: pain level, functional activity, joint range of motion, and hip joint deformity. The total score ranges from 0 to 100, with 100 being the best possible condition, indicating complete normalcy of hip joint function.
Measured: 1 year
SF-36 score
The SF-36 (Short Form 36 Health Survey) is a widely used generic health status assessment tool developed by the Medical Outcomes Study (MOS) Group. The scale is designed to comprehensively evaluate health-related quality of life, encompassing eight dimensions: physical functioning, social functioning, role limitations due to physical health, role limitations due to emotional problems, bodily pain, mental health, vitality, and general health perceptions. Each dimension consists of several items, and scores are derived by summing the scores of these items, typically converted to a 0 to 100 percent scale, with 100 representing the best possible health state. These eight dimension scores can be combined to form two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fracture of Neck of FemurStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Wei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713018
- Sponsor's protocol ID
- S2024-341-01
- Status last verified
- Dec 2024
- First submitted
- 16 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li M, Tong D, Cheng M, Li J, Ji F, Zhang W. Navigation System-Assisted vs Freehand Cannulated Screw Fixation for Femoral Neck Fractures: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 23;15:e88180. doi: 10.2196/88180.
PubMed 42335459
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Clinical Study of Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT06713018
- Acronym / sponsor ID
- S2024-341-01
- Conditions
- Fracture of Neck of Femur
- Keywords
- orthopedic intelligent navigation system
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 3 Dec 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.
The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures.
Participants will:
- Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures.
- Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Three cannulated compression screws by navigation system | Experimental | Procedure: Three cannulated compression screws by navigation system |
| Traditional three cannulated compression screws | Placebo comparator | Procedure: Traditional three cannulated compression screws |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years old, gender is not limited;
- Patients diagnosed with femoral neck fracture;
- Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
- The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.
Key exclusion criteria (9 listed)
- Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit;
- The patient is known to have a history of allergy to one or more implanted materials;
- Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
- Active infection of the hip joint or other parts of the body is determined by the investigator;
- Diagnosed as metabolic bone disease, radiation bone disease, etc.;
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 |
|---|---|---|
| Three cannulated compression screws by navigation systemPatients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system | Procedure or surgery | Three cannulated compression screws by navigation system |
| Traditional three cannulated compression screwsPatients with femoral neck fractures treated with traditional three cannulated compression screws | Procedure or surgery | Traditional three cannulated compression screws |
Primary outcome
Perspective frequency
Time frame: 1 day
Document the total number of intraoperative fluoroscopy sessions taken during surgery, including each anteroposterior and lateral fluoroscopic image
9 secondary outcomes
Neck shaft angle
Time frame: 1 year
Guide needle implantation effect
Time frame: 1 day
Fluoroscopy times of needle implantation
Time frame: 1 day
Operation time
Time frame: 1 day
Operative blood loss
Time frame: 1 day
Fracture union
Time frame: 1 year
Zarit Burden Interview score
Time frame: 1 year
Harris score
Time frame: 1 year
SF-36 score
Time frame: 1 year
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 3 Dec 2024.
- Derived from this study: PubMed 42335459Li M, Tong D, Cheng M, Li J, Ji F, Zhang W. Navigation System-Assisted vs Freehand Cannulated Screw Fixation for Femoral Neck Fractures: Protocol for a Multicenter Randomized Controlled Trial. JMIR Res Protoc. 2026 Jun 23;15:e88180. doi: 10.2196/88180.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three cannulated compression screws by navigation system and Traditional three cannulated compression screws in people with Fracture of Neck of Femur, run by Chinese PLA General 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 4 inclusion and 9 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 3 Dec 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 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. Some participants in this study may receive a placebo. 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?
Contact Wei Zhang (+8612409252, bszw@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perspective frequency (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713018, which also lists 1 linked publication.
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 3 Dec 2024.