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Not yet recruitingNCT06713018Updated Dec 3, 2024

Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures

An interventional study of Three cannulated compression screws by navigation system and Traditional three cannulated compression screws in Fracture of Neck of Femur, sponsored by Chinese PLA General Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.

Sponsored by Chinese PLA General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
  • Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.
02

Conditions studied

  • Fracture of Neck of Femur

Keywords

  • orthopedic intelligent navigation system
03

In context

Fractures, Bone

2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.

This study's planned enrollment of 300 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.

Browse Fractures, Bone studies →

Lead sponsor

Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥18 years old, gender is not limited;
  2. Patients diagnosed with femoral neck fracture;
  3. Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
  4. The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. The patient is known to have a history of allergy to one or more implanted materials;
  3. Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
  4. Active infection of the hip joint or other parts of the body is determined by the investigator;
  5. Diagnosed as metabolic bone disease, radiation bone disease, etc.;
  6. Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
  7. have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
  8. The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
  9. Other conditions deemed unsuitable for inclusion by the investigator.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Three cannulated compression screws by navigation system

    Procedure: Three cannulated compression screws by navigation system

  • Placebo comparator
    Traditional three cannulated compression screws

    Procedure: Traditional three cannulated compression screws

Interventions

  • ProcedureThree cannulated compression screws by navigation system

    Patients with femoral neck fractures treated with three cannulated compression screws assisted by a navigation system

  • ProcedureTraditional three cannulated compression screws

    Patients with femoral neck fractures treated with traditional three cannulated compression screws

06

What researchers measure

Primary outcomes

  1. Perspective frequency

    Document the total number of intraoperative fluoroscopy sessions taken during surgery, including each anteroposterior and lateral fluoroscopic image

    Time frame: 1 day

Secondary outcomes

  1. Neck shaft angle

    Time frame: 1 year

  2. 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.

    Time frame: 1 day

  3. Fluoroscopy times of needle implantation

    Time frame: 1 day

  4. Operation time

    Time frame: 1 day

  5. Operative blood loss

    Time frame: 1 day

  6. 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.

    Time frame: 1 year

  7. 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.

    Time frame: 1 year

  8. 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.

    Time frame: 1 year

  9. 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).

    Time frame: 1 year

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06713018
Lead sponsor
Chinese PLA General Hospital
Responsible party
Zhang Wei (Deputy head of orthopedics, Chinese PLA General Hospital) — Principal investigator
First posted
Dec 3, 2024
Start date
Dec 10, 2024 (estimated)
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Dec 3, 2024

Study contacts

Wei Zhang
Contact
bszw@hotmail.com
+8612409252

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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