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The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures (INCST)

Primary Purpose

Pelvic Fracture

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intraoperative navigation combined with Catheter screw technique
Open reduction and internal fixation with steel plate
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Fracture

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  1. inpatients diagnosed with unstable pelvic acetabular fractures (tile B, C);
  2. sacroiliac joint dislocations and longitudinal sacral fractures that do not require sacral nerve or sacral canal decompression;
  3. closed reduction to functional reduction criteria before posterior pelvic ring. Exclusion Criteria

1)stable posterior pelvic ring injury (Tile A type); 2)preoperative closed reduction to achieve functional reduction; 3)patients with severe osteoporosis; 4)heart, liver, kidney, and other essential organ lesions cannot tolerate surgery.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Experimental group

    Control Group

    Arm Description

    It uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures

    This approach typically requires extensive surgical exposure and large-scale soft-tissue dissection, which quickly leads to some serious complications, including increased rates of infection, poor wound healing, increased damage to large vessels or nerves, and heterotopic ossification

    Outcomes

    Primary Outcome Measures

    Pelvic change
    fracture displacement < 4 mm was excellent, 4-10 mm was good, 10-20 mm was fair, and > 20 mm was poor.

    Secondary Outcome Measures

    screw position
    Class I, safe implantation, the screw was completely in the cancellous bone; Class II, safe implantation, the screw contacted the cortical structure ; Class III, wrong implantation, the screw penetrated the cortical bone.
    pubic ramus screws
    grade 0, no penetration of the bone cortex; grade 1, penetration of the bone cortex screw length < 2 mm; grade 2, penetration of the bone cortex screw length 2-4 mm; grade 3, penetration of the bone cortex screw length > 4 mm.
    VAS scores VAS scores
    Evaluation of postoperative pain
    The length of hospital stay
    The total length of stay of the patient in the hospital
    Total cost of hospitalization
    Overall cost of hospitalization
    Pelvic X-ray was taken to record the fracture healing, hip joint function
    X-ray evaluation of fracture healing

    Full Information

    First Posted
    July 4, 2022
    Last Updated
    July 29, 2022
    Sponsor
    First Affiliated Hospital Xi'an Jiaotong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05448911
    Brief Title
    The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures
    Acronym
    INCST
    Official Title
    The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures: A Multicenter, Prospective, Randomized, Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2022 (Anticipated)
    Primary Completion Date
    June 2023 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    First Affiliated Hospital Xi'an Jiaotong University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This was a multicenter, prospective, randomized, controlled study. Patients with pelvic fractures (Tile B and c) were recruited from the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an Red Society Hospital and Xi'an 521 hospital, the patients were randomly divided into two groups according to the Order of admission: Experimental Group (intraoperative navigation combined with channel screw technique) and Control Group (open reduction and plate internal fixation) , the difference of operative effect between the two groups was compared by fracture reduction, channel screw position, operative time, fluoroscopy frequency, hospitalization time, hospitalization cost, recovery time and Mayo Score. Use Access 2003 to build a database and store data; use SPSS 21.0. 0 Software for statistical analysis. The entire process required the development of a standardized staff manual, and all were subject to rigorous training and examination in order to participate in the pilot, and the investigation process was supervised by the project leader.
    Detailed Description
    With the rapid development of the transportation industry and construction industry, pelvic fractures caused by high-energy injuries are increasing year by year, accounting for about 3% -5% of total body fractures. This disease seriously endangers the lives of patients. Once it occurs, the mortality and disability rate are high. Finding the appropriate treatment has been the direction explored by orthopedic surgeons . Undisplaced pelvic fractures can usually be treated conservatively, which has the advantages of low cost and minor trauma, but heavily displaced fractures often require surgery due to the destruction of pelvic stability structures. Conservative treatment cannot achieve functional reduction or even anatomical reduction (Fig. Traditional open reduction and internal fixation with steel plate is the mainstream treatment at present. Still, this method usually requires extensive surgical exposure and massive dissection of soft tissue, which quickly causes some severe complications, including increased infection rate, poor wound healing, increased macrovascular or nerve injury, and heterotopic ossification . At the same time, with the arrival of an aging society, there are more and more pelvic fractures in the elderly in clinical practice, and the treatment faces many challenges. First, the elderly have a poor physical conditions, are primarily associated with medical diseases of varying severity, and have poor tolerance to surgery. Second, with different degrees of decreased bone conditions, some patients with severe osteoporosis have fractures that are difficult to reduce and effectively fix. Their treatment far exceeds the choice between conservative treatment and surgical treatment, requiring multidisciplinary teamwork, including orthopedics, geriatrics, endocrinology, pain, and rehabilitation physiotherapy. The principle of treatment for elderly patients with a pelvic fracture is as follows: while the fixation is as strong as possible, minimally invasive fixation should be adopted as far as possible to reduce the surgical blow and related complications. Therefore, the minimally invasive channel screw technique has become a hot spot in the treatment of pelvic fractures. In recent years, the minimally invasive channel screw technique has been gradually paid attention to by clinicians. It mainly uses a minimally invasive small incision, uses the physiological channel of the pelvis, and uses cannulated screws to fix pelvic and acetabular fractures. This technique provides a reliable and stable fixation of the pelvic acetabulum, which is equivalent to or superior to other existing internal fixation techniques such as plates from a biomechanical point of view, can achieve the effect of open reduction and internal fixation and can avoid complications such as more bleeding and extensive soft tissue dissection caused by open surgery, which will become the most popular method for the treatment of pelvic acetabular fractures. The project group previously tried the channel screw technique for the treatment of pelvic fractures and found that although this method has the advantages of minimally invasive and rapid recovery, it still has the following problems: due to the small incision, it cannot fully expose the visual field and is easy to damage the peripheral blood vessels and nerves. Continuous fluoroscopy under the C-arm is required, and the radiation dose received by patients and physicians is large; for the technical and empirical requirements of physicians, the learning curve of young physicians is high. General anesthesia is used during the operation, which increases the risk of removal of the endotracheal tube if the operation time is high. The development and popularization of intraoperative navigation technology provide the possibility to solve the above problems. Navigation technology is widely used in many fields such as transportation, exploration, military, and exploration. With the continuous development of computer technology, especially the rapid progress of computer graphics technology, a new field of computer-assisted surgery (CAS) has emerged, and computer-assisted navigation system (CANS) is an important part of it. The computer-assisted surgical navigation system is a combination of spatial three-dimensional stereotactic technology, modern imaging diagnostic technology, computer image processing technology, three-dimensional visualization technology, and minimally invasive surgical techniques. It uses signal transmission, transmission, and reception transmitters to calculate the data of each position point through a computer to obtain the required various curves and angles so that the various parameters of the intangible and virtual human body are converted into direct animated images while the position of surgical instruments is displayed in real-time on the surgical images, and the doctor can understand the relationship between the position of instruments and anatomical structures at any time so that the surgical operation becomes safer, more accurate and less invasive. The current application of navigation technology in orthopedics is mainly focused on spinal surgery, which is less used in the field of trauma. Due to the special anatomy of the spine and spinal cord, the high accuracy and safety of surgery are the first considerations. In 1995, Nolte implemented the world's first lumbar pedicle screw internal fixation surgery using a computer-assisted minimally invasive navigation surgical system, which began the use of navigation technology in spinal surgery, and Nolte et al. found that the accuracy of the photoelectric spinal navigation system could reach 1-1.7 mm, and image-guided technology allowed surgeons to clearly understand the spinal anatomy and the pedicle screw needle insertion point and needle insertion direction, and fixed pedicle screws in the correct position of the vertebral body by real-time tracking to improve the surgical accuracy. Channel screw therapy for pelvic fractures is a difficult surgery in the field of trauma. Navigation is used during screw placement. The specific position of the guide needle can be determined according to the real-time three-dimensional picture displayed by the system. The direction of the real guide needle can be corrected by adjusting the direction of the virtual guide needle in time during surgery, providing a safety guarantee for screw placement . In this study, the patients with pelvic fractures (Tile B and C) admitted to the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an Red Cross Hospital, and Xi'an 521 Hospital were used as the cohort study basis, intraoperative navigation combined with channel screw technique was used as the experimental group, and open reduction and internal fixation with steel plate were used as the control group. Through intraoperative evaluation and postoperative follow-up, the surgical effects were compared between the two groups. To explore the significance of intraoperative navigation assisted channel screw technology in the treatment of pelvic fracture, expect that this treatment can reduce the number of fluoroscopies, shorten the operation time, improve postoperative satisfaction of patients, reduce the length of hospital stay and reduce medical costs, and finally this treatment method can be popularized and applied.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pelvic Fracture

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group
    Arm Type
    Experimental
    Arm Description
    It uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures
    Arm Title
    Control Group
    Arm Type
    Other
    Arm Description
    This approach typically requires extensive surgical exposure and large-scale soft-tissue dissection, which quickly leads to some serious complications, including increased rates of infection, poor wound healing, increased damage to large vessels or nerves, and heterotopic ossification
    Intervention Type
    Procedure
    Intervention Name(s)
    Intraoperative navigation combined with Catheter screw technique
    Intervention Description
    It uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures
    Intervention Type
    Procedure
    Intervention Name(s)
    Open reduction and internal fixation with steel plate
    Intervention Description
    Open reduction and plate internal fixation is the most commonly used method to treat pelvic fracture, which can achieve anatomical reduction and rigid fixation. However, this method requires extensive dissection of the surrounding soft-tissue fracture and is invasive
    Primary Outcome Measure Information:
    Title
    Pelvic change
    Description
    fracture displacement < 4 mm was excellent, 4-10 mm was good, 10-20 mm was fair, and > 20 mm was poor.
    Time Frame
    From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 month
    Secondary Outcome Measure Information:
    Title
    screw position
    Description
    Class I, safe implantation, the screw was completely in the cancellous bone; Class II, safe implantation, the screw contacted the cortical structure ; Class III, wrong implantation, the screw penetrated the cortical bone.
    Time Frame
    follow-up of 3 months, 6 months and 12 months
    Title
    pubic ramus screws
    Description
    grade 0, no penetration of the bone cortex; grade 1, penetration of the bone cortex screw length < 2 mm; grade 2, penetration of the bone cortex screw length 2-4 mm; grade 3, penetration of the bone cortex screw length > 4 mm.
    Time Frame
    follow-up of 3 months, 6 months and 12 months
    Title
    VAS scores VAS scores
    Description
    Evaluation of postoperative pain
    Time Frame
    follow-up of 3 months, 6 months and 12 months
    Title
    The length of hospital stay
    Description
    The total length of stay of the patient in the hospital
    Time Frame
    follow-up of 3 months, 6 months and 12 months
    Title
    Total cost of hospitalization
    Description
    Overall cost of hospitalization
    Time Frame
    follow-up of 3 months, 6 months and 12 months
    Title
    Pelvic X-ray was taken to record the fracture healing, hip joint function
    Description
    X-ray evaluation of fracture healing
    Time Frame
    follow-up of 3 months, 6 months and 12 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria inpatients diagnosed with unstable pelvic acetabular fractures (tile B, C); sacroiliac joint dislocations and longitudinal sacral fractures that do not require sacral nerve or sacral canal decompression; closed reduction to functional reduction criteria before posterior pelvic ring. Exclusion Criteria 1)stable posterior pelvic ring injury (Tile A type); 2)preoperative closed reduction to achieve functional reduction; 3)patients with severe osteoporosis; 4)heart, liver, kidney, and other essential organ lesions cannot tolerate surgery.

    12. IPD Sharing Statement

    Learn more about this trial

    The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures

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