Fracture of Femoral NeckNCT06713291
Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures
A study testing Sliding compression locking plate and Three cannulated compression screws in people with Fracture of Femoral Neck, run by Chinese PLA General Hospital at 3 sites in China.
Trial summary
To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture of Femoral Neck
- What is being tested?
- Sliding compression locking plate and 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
- 1,150 participants
- Where
- 3 sitesChina
- 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
the First Centre of PLA General Hospital
Beijing, Beijing Municipality, 100048
Wei
- Not yet recruiting
Chinese PLA General Hosptial
Beijing
Meng Li, +8615334508850, limeng1@301hospital.com.cn
- Recruiting
the First Medical Center of PLA General Hospital
Beijing
Wei 66848653 Zhang, +8615334508850, zhangwei@301hospital.com.cn
About this study
Official title: Prospective, Multicenter, Randomized Controlled Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures
To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures
- Conditions
- Fracture of Femoral Neck
- Being tested
- Sliding compression locking plate, Three cannulated compression screws
- Keywords
- fracture of neck of femur, sliding compression locking plate, compression screws
- 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.
Sliding compression locking plateProcedure or surgery
The patients with femoral neck fracture were treated with three cannulated compression screws or sliding compression locking plate.
Three cannulated compression screwsProcedure or surgery
The patients with femoral neck fracture were treated with three cannulated compression screws.
| Study group | Role | What they receive |
|---|---|---|
| Sliding compression locking plate | Experimental | Patients with femoral neck fracture were treated with sliding compression locking plate internal fixation. Receives: Procedure: Sliding compression locking plate |
| Three cannulated compression screws | Placebo comparator | The patients with femoral neck fracture were treated with three cannulated compression screws. Receives: Procedure: Three cannulated compression screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral neck shortened
The difference in femoral neck length between 1 week post-surgery and 6 months and 12 months post-surgery, measured via X-ray and CT imaging examinations.
Measured: 1 year
Secondary outcomes (8)
Neck shaft angle
Measured: 1 year
The effectiveness of guide pin implantation
For the cohort treated with three cannulated compression screws, the effectiveness of guide pin implantation is categorized into three parallel, two parallel, and non-parallel arrangements，which will be measured during the surgery.
Measured: 1 day
Time of operation
Measured: 1 day
Blood loss
Measured: 1 day
Bone union
Measured: 1 year
Zarit Burden Interview（ZBI）
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
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
Harris Hip Score:
The Harris Hip Score is a clinician-reported outcome measure assessing hip function, including pain, function, absence of deformity, and range of motion, used to evaluate outcomes after hip surgery.
Measured: hip function is assessed during outpatient follow-up at 1, 3, 6, and 12 months postoperatively using the Harris Hip Score system.
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
- 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.
- Other trials for Fracture of Femoral NeckStudies 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
- 1,150 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
- NCT06713291
- Sponsor's protocol ID
- Chinese PLA General Hosptial
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2024
- Last updated
- 2 Apr 2026
- 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 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Randomized Controlled Clinical Study of a Novel Sliding Compression Locking Plate in the Treatment of Fresh Femoral Neck Fractures
- ClinicalTrials.gov ID
- NCT06713291
- Acronym / sponsor ID
- Chinese PLA General Hosptial
- Conditions
- Fracture of Femoral Neck
- Keywords
- fracture of neck of femur, sliding compression locking plate, compression screws
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- 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.
To verify the safety and efficacy of sliding compression locking plates in the treatment of fresh femoral neck fractures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sliding compression locking plate | Experimental | Procedure: Sliding compression locking platePatients with femoral neck fracture were treated with sliding compression locking plate internal fixation. |
| Three cannulated compression screws | Placebo comparator | Procedure: Three cannulated compression screwsThe patients with femoral neck fracture were treated with 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 |
|---|---|---|
| Sliding compression locking plateThe patients with femoral neck fracture were treated with three cannulated compression screws or sliding compression locking plate. | Procedure or surgery | Sliding compression locking plate |
| Three cannulated compression screwsThe patients with femoral neck fracture were treated with three cannulated compression screws. | Procedure or surgery | Three cannulated compression screws |
Primary outcome
Femoral neck shortened
Time frame: 1 year
The difference in femoral neck length between 1 week post-surgery and 6 months and 12 months post-surgery, measured via X-ray and CT imaging examinations.
8 secondary outcomes
Neck shaft angle
Time frame: 1 year
The effectiveness of guide pin implantation
Time frame: 1 day
Time of operation
Time frame: 1 day
Blood loss
Time frame: 1 day
Bone union
Time frame: 1 year
Zarit Burden Interview（ZBI）
Time frame: 1 year
SF-36 Score
Time frame: 1 year
Harris Hip Score:
Time frame: hip function is assessed during outpatient follow-up at 1, 3, 6, and 12 months postoperatively using the Harris Hip Score system.
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 2 Apr 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sliding compression locking plate and Three cannulated compression screws in people with Fracture of Femoral Neck, run by Chinese PLA General Hospital at 3 sites 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: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 (+8618612409252, bszw@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral neck shortened (time frame: 1 year). 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 2 Apr 2026.