Pelvic FractureINCSTNCT05448911
The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures
A study testing Intraoperative navigation combined with Catheter screw technique and Open reduction and internal fixation with steel plate in people with Pelvic Fracture, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pelvic Fracture
- What is being tested?
- Intraoperative navigation combined with Catheter screw technique and Open reduction and internal fixation with steel plate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jan 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
Official title: The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures: A Multicenter, Prospective, Randomized, Controlled Study
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.
Read the 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.
- Conditions
- Pelvic Fracture
- Being tested
- Intraoperative navigation combined with Catheter screw technique, Open reduction and internal fixation with steel plate
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative navigation combined with Catheter screw techniqueProcedure or surgery
It uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures
Open reduction and internal fixation with steel plateProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | It uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures Receives: Procedure: Intraoperative navigation combined with Catheter screw technique |
| Control Group | Other | 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 Receives: Procedure: Open reduction and internal fixation with steel plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic change
fracture displacement < 4 mm was excellent, 4-10 mm was good, 10-20 mm was fair, and > 20 mm was poor.
Measured: 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 outcomes (6)
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.
Measured: follow-up of 3 months, 6 months and 12 months
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.
Measured: follow-up of 3 months, 6 months and 12 months
VAS scores VAS scores
Evaluation of postoperative pain
Measured: follow-up of 3 months, 6 months and 12 months
The length of hospital stay
The total length of stay of the patient in the hospital
Measured: follow-up of 3 months, 6 months and 12 months
Total cost of hospitalization
Overall cost of hospitalization
Measured: follow-up of 3 months, 6 months and 12 months
Pelvic X-ray was taken to record the fracture healing, hip joint function
X-ray evaluation of fracture healing
Measured: follow-up of 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic FractureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448911
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-011
- Acronym
- INCST
- Status last verified
- Jun 2022
- First submitted
- 4 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Intraoperative Navigation-assisted Channel Screw Technique in the Treatment of Pelvic Fractures: A Multicenter, Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT05448911
- Acronym / sponsor ID
- INCST / XJTU1AF-CRF-2020-011
- Conditions
- Pelvic Fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 8 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Intraoperative navigation combined with Catheter screw techniqueIt uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures |
| Control Group | Other | Procedure: Open reduction and internal fixation with steel plateThis 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intraoperative navigation combined with Catheter screw techniqueIt uses minimally invasive small incisions, physiological access to the pelvis, and hollow screws for Pelvic and Acetabular fractures | Procedure or surgery | Experimental group |
| Open reduction and internal fixation with steel plateOpen 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 | Procedure or surgery | Control Group |
Primary outcome
Pelvic change
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
fracture displacement < 4 mm was excellent, 4-10 mm was good, 10-20 mm was fair, and > 20 mm was poor.
6 secondary outcomes
screw position
Time frame: follow-up of 3 months, 6 months and 12 months
pubic ramus screws
Time frame: follow-up of 3 months, 6 months and 12 months
VAS scores VAS scores
Time frame: follow-up of 3 months, 6 months and 12 months
The length of hospital stay
Time frame: follow-up of 3 months, 6 months and 12 months
Total cost of hospitalization
Time frame: follow-up of 3 months, 6 months and 12 months
Pelvic X-ray was taken to record the fracture healing, hip joint function
Time frame: follow-up of 3 months, 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative navigation combined with Catheter screw technique and Open reduction and internal fixation with steel plate in people with Pelvic Fracture, run by First Affiliated Hospital Xi'an Jiaotong University.
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 0 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 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvic change (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). 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 1 Aug 2022.