Irreducible Atlantoaxial DislocationNCT05847270
Surgical Treatment of Irreducible Atlantoaxial Dislocation
A study testing Anterior and posterior treatment strategy and Simple posterior approach treatment strategy in people with Irreducible Atlantoaxial Dislocation, run by Peking University Third Hospital at 1 site in China.
Trial summary
At present, there is a lack of standardized, large-scale, and high-level evidence-based medicine research on the safety and effectiveness of treatment of irreducible atlantoaxial dislocation (IAAD).Based on this, the goal of this prospective randomized controlled study is to systematically investigate the optimal… Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Irreducible Atlantoaxial Dislocation
- What is being tested?
- Anterior and posterior treatment strategy and Simple posterior approach treatment strategy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2023to 31 Dec 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Eligible participants encompass individuals within the age range of 0 to 80 years, without regard to gender.
- Patients who have received a diagnosis of irreducible atlantoaxial dislocation (IAAD) based on preoperative imaging and skull traction evaluation, with a traction weight equivalent to 1/6 of their body weight following anesthesia. These patients are candidates for surgical intervention.
- Participants who have provided informed consent either in person or through their legal representative (the principal).
Who cannot join
- Individuals with concomitant medical conditions or diseases that significantly impact surgical treatment, such as malignant metastasis or infectious diseases, will be excluded from the study.
- Critically ill patients, who are not suitable candidates for surgical intervention, will also be excluded.
- Patients who actively decline to participate in this research project will not be included in the study cohort.
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, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Shenglin Wang, MD, +86 13501380281, pkuwsl@126.com
Shilin Xue, MD, +86 18518982712, shilinx_pku@163.com
About this study
Official title: A Randomized Controlled Study for Surgical Treatment of Irreducible Atlantoaxial Dislocation
At present, there is a lack of standardized, large-scale, and high-level evidence-based medicine research on the safety and effectiveness of treatment of irreducible atlantoaxial dislocation (IAAD).Based on this, the goal of this prospective randomized controlled study is to systematically investigate the optimal surgical approach (simple posterior approach and the combined anterior and posterior approach) for managing IAAD, providing insights into the most efficacious and safest course of action. And long-term follow-up will be conducted on patients to evaluate the safety and effectiveness of different surgical methods, and to develop diagnostic and treatment standards for irreducible atlantoaxial dislocation.
Read the detailed description
The choice of surgical strategies for treating irreducible atlantoaxial dislocation (IAAD) is still a controversial topic. Surgical approaches under consideration of IAAD encompass the simple posterior approach and the combined anterior and posterior approach. The former offers procedural simplicity but has inherent limitations in the extent of reduction. In contrast, the latter approach holds the potential for a more comprehensive and reliable release and reduction. However, it also presents an elevated risk of infection and surgical complexity. The choice between these two strategies remains a controversy. Based on this, the goal of this prospective randomized controlled study is to systematically investigate the optimal surgical approach for managing IAAD, providing insights into the most efficacious and safest course of action.
Six high-level centers for the treatment of IAAD participated in this randomized controlled study. After rigorous sample size analysis, we plan to recruit 260 IAAD patients into two distinct trial groups: the "Simple Posterior Surgery Group" and the "Combined Anterior and Posterior Surgery Group". By analysing the comprehensive radiological assessment, the systematic tracking of neurological function improvement, meticulous evaluation of specific adverse events and a 12 month post-surgery follow-up we will systematically investigate the optimal surgical approach for managing IAAD.
Besides, this research endeavor has received full ethical clearance from the Peking University Third Hospital (PUTH) Medical Science Research Ethics Committee (IRB00006761-M2023203). All enrolled participants will provide informed consent voluntarily.
- Conditions
- Irreducible Atlantoaxial Dislocation
- Being tested
- Anterior and posterior treatment strategy, Simple posterior approach treatment strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior and posterior treatment strategyProcedure or surgery
Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is difficult to restore the dislocation, a technique of anterior oral release and posterior fixation fusion was used for reduction, with sequential release of the longus colli and longus capitis, the anterior longitudinal ligament, the blitateral lateral mass joints, the contracted soft-tissue mass between the odotiod and the anterior C1 tubercle, and the peri-odontoid ligaments (i.e., the alar ligaments and the apical ligament), followed by posterior internal fixation and bone grafting was used between C1 and C2 lamina.
Simple posterior approach treatment strategyProcedure or surgery
Preceding the surgical procedure, an assessment was conducted utilizing 1/6 weight traction to ascertain the reducibility of atlantoaxial dislocation. Upon confirmation of IAAD, the chosen approach involved the utilization of a specially designed spreader, tailored to the patient's atlanto-axial joint morphology. Upon entering the joint space, the spreaders were skillfully maneuvered to gently open the joint through rotational and prying actions. Subsequently, two cages, pre-filled with autogenous bone grafts, and designed with the appropriate angle and height, were meticulously placed between the Atlanto-axial joints via a posterior approach. This procedure facilitated direct distraction and reduction of the dislocated joint. In the final step of the surgical process, stabilization was achieved by securing the atlas and axis with screws and rods. This surgical approach was selected to address the unique challenges posed by IAAD, with the aim of achieving optimal patient outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Anterior and posterior treatment strategy | Experimental | Anterior transoral release and reduction + posterior internal fixation and bone graft fusion Receives: Procedure: Anterior and posterior treatment strategy |
| Simple Posterior Approach Treatment Strategy | Experimental | posterior reduction and internal fixation Receives: Procedure: Simple posterior approach treatment strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Decompression Rate
Effective spinal cord decompression on MRI, and the arachnoid space between the spinal cord and the odontoid process can reappear.
Measured: 12 months
Bone Graft Fusion Rate
Evaluation of the proportion of patients exhibiting successful bone fusion between the atlas and axis will be conducted through postoperative three-dimensional CT examinations of the cervical spine. The bone graft fusion rate will be determined by calculating the number of patients with evident fusion relative to the total number of patients enrolled.
Measured: 12 months
Atlantoaxial Reduction Rate
To gauge the effectiveness of the surgical interventions in achieving atlantoaxial reduction, postoperative CT scans of the head and neck will be conducted. Measurements will be taken of the distance between the odontoid process and key reference lines, including Chamberlain's line (CL), Wackenheim line (WL), McRae line (ML), and atlantodental interval (ADI). The reduction rate will be calculated by comparing the postoperative measurements to the preoperative values, expressed as a ratio.
Measured: 12 months
Secondary outcomes (3)
Incidence of Adverse Events (12 Months After Surgery)
The primary focus of evaluation is on the incidence of adverse events occurring within the 12-month post-surgery period. This metric is defined as the proportion of adverse events that manifest during the study's duration relative to the total number of patients enrolled. Adverse events encompass a range of critical factors, including but not limited to: Neurological deterioration, Incision infection, Vascular injury, Airway obstruction, Poor reduction, Unplanned readmission and re-surgery, Internal fixation failure, Fusion failure, Surgical-related lower cervical spine deformities.
Measured: 12 months
Improvement Rate of Quality of Life (12 Months After Surgery)
The quality of life for each patient will be assessed using the SF-12 Health Survey. The improvement rate in quality of life will be calculated based on the preoperative and postoperative differences in SF-12 scores. This indicator offers insights into the impact of surgical interventions on patients' overall well-being and quality of life, providing a vital perspective on treatment effectiveness.
Measured: 12 months
Improvement of Neurological Function
To assess the extent of neurological function improvement, patients' JOA scores one year after surgery will be compared with their preoperative scores. The JOA improvement rate will be calculated based on the cervical JOA score, employing the Hirabayashi method formula: JOA Improvement Rate = (Postoperative JOA Score - Preoperative JOA Score) / (17 - Preoperative JOA Score) * 100%
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start11 Jul 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreducible Atlantoaxial DislocationStudies of the same condition, open and under way.
- More trials run by Peking University Third 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
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Affiliated Hospital of Wenzhou Medical University, Tianjin People's Hospital, First Affiliated Hospital of Kunming Medical University
- Responsible party
- Principal investigator, Wang Shenglin, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05847270
- Sponsor's protocol ID
- M2023203
- Status last verified
- Jan 2024
- First submitted
- 14 Apr 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- 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 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study for Surgical Treatment of Irreducible Atlantoaxial Dislocation
- ClinicalTrials.gov ID
- NCT05847270
- Acronym / sponsor ID
- M2023203
- Conditions
- Irreducible Atlantoaxial Dislocation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Affiliated Hospital of Wenzhou Medical University, Tianjin People's Hospital, First Affiliated Hospital of Kunming Medical University
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 May 2023 (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.
At present, there is a lack of standardized, large-scale, and high-level evidence-based medicine research on the safety and effectiveness of treatment of irreducible atlantoaxial dislocation (IAAD).Based on this, the goal of this prospective randomized controlled study is to systematically investigate the optimal surgical approach (simple posterior approach and the combined anterior and posterior approach) for managing IAAD, providing insights into the most efficacious and safest course of action. And long-term follow-up will be conducted on patients to evaluate the safety and effectiveness of different surgical methods, and to develop diagnostic and treatment standards for irreducible atlantoaxial dislocation.
Detailed description
The choice of surgical strategies for treating irreducible atlantoaxial dislocation (IAAD) is still a controversial topic. Surgical approaches under consideration of IAAD encompass the simple posterior approach and the combined anterior and posterior approach. The former offers procedural simplicity but has inherent limitations in the extent of reduction. In contrast, the latter approach holds the potential for a more comprehensive and reliable release and reduction. However, it also presents an elevated risk of infection and surgical complexity. The choice between these two strategies remains a controversy. Based on this, the goal of this prospective randomized controlled study is to systematically investigate the optimal surgical approach for managing IAAD, providing insights into the most efficacious and safest course of action.
Six high-level centers for the treatment of IAAD participated in this randomized controlled study. After rigorous sample size analysis, we plan to recruit 260 IAAD patients into two distinct trial groups: the "Simple Posterior Surgery Group" and the "Combined Anterior and Posterior Surgery Group". By analysing the comprehensive radiological assessment, the systematic tracking of neurological function improvement, meticulous evaluation of specific adverse events and a 12 month post-surgery follow-up we will systematically investigate the optimal surgical approach for managing IAAD.
Besides, this research endeavor has received full ethical clearance from the Peking University Third Hospital (PUTH) Medical Science Research Ethics Committee (IRB00006761-M2023203). All enrolled participants will provide informed consent voluntarily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior and posterior treatment strategy | Experimental | Procedure: Anterior and posterior treatment strategyAnterior transoral release and reduction + posterior internal fixation and bone graft fusion |
| Simple Posterior Approach Treatment Strategy | Experimental | Procedure: Simple posterior approach treatment strategyposterior reduction and internal fixation |
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible participants encompass individuals within the age range of 0 to 80 years, without regard to gender.
- Patients who have received a diagnosis of irreducible atlantoaxial dislocation (IAAD) based on preoperative imaging and skull traction evaluation, with a traction weight equivalent to 1/6 of their body weight following anesthesia. These patients are candidates for surgical intervention.
- Participants who have provided informed consent either in person or through their legal representative (the principal).
Key exclusion criteria (3 listed)
- Individuals with concomitant medical conditions or diseases that significantly impact surgical treatment, such as malignant metastasis or infectious diseases, will be excluded from the study.
- Critically ill patients, who are not suitable candidates for surgical intervention, will also be excluded.
- Patients who actively decline to participate in this research project will not be included in the study cohort.
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 |
|---|---|---|
| Anterior and posterior treatment strategyBefore surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is difficult to restore the dislocation, a technique of anterior oral release and posterior fixation fusion was used for reduction, with sequential release of the longus colli and longus capitis, the anterior longitudinal ligament, the blitateral lateral mass joints, the contracted soft-tissue mass between the odotiod and the anterior C1 tubercle, and the peri-odontoid ligaments (i.e., the alar ligaments and the apical ligament), followed by posterior internal fixation and bone grafting was used between C1 and C2 lamina. | Procedure or surgery | Anterior and posterior treatment strategy |
| Simple posterior approach treatment strategyPreceding the surgical procedure, an assessment was conducted utilizing 1/6 weight traction to ascertain the reducibility of atlantoaxial dislocation. Upon confirmation of IAAD, the chosen approach involved the utilization of a specially designed spreader, tailored to the patient's atlanto-axial joint morphology. Upon entering the joint space, the spreaders were skillfully maneuvered to gently open the joint through rotational and prying actions. Subsequently, two cages, pre-filled with autogenous bone grafts, and designed with the appropriate angle and height, were meticulously placed between the Atlanto-axial joints via a posterior approach. This procedure facilitated direct distraction and reduction of the dislocated joint. In the final step of the surgical process, stabilization was achieved by securing the atlas and axis with screws and rods. This surgical approach was selected to address the unique challenges posed by IAAD, with the aim of achieving optimal patient outcomes. | Procedure or surgery | Simple Posterior Approach Treatment Strategy |
Primary outcome
Complete Decompression Rate
Time frame: 12 months
Effective spinal cord decompression on MRI, and the arachnoid space between the spinal cord and the odontoid process can reappear.
Bone Graft Fusion Rate
Time frame: 12 months
Evaluation of the proportion of patients exhibiting successful bone fusion between the atlas and axis will be conducted through postoperative three-dimensional CT examinations of the cervical spine. The bone graft fusion rate will be determined by calculating the number of patients with evident fusion relative to the total number of patients enrolled.
Atlantoaxial Reduction Rate
Time frame: 12 months
To gauge the effectiveness of the surgical interventions in achieving atlantoaxial reduction, postoperative CT scans of the head and neck will be conducted. Measurements will be taken of the distance between the odontoid process and key reference lines, including Chamberlain's line (CL), Wackenheim line (WL), McRae line (ML), and atlantodental interval (ADI). The reduction rate will be calculated by comparing the postoperative measurements to the preoperative values, expressed as a ratio.
3 secondary outcomes
Incidence of Adverse Events (12 Months After Surgery)
Time frame: 12 months
Improvement Rate of Quality of Life (12 Months After Surgery)
Time frame: 12 months
Improvement of Neurological Function
Time frame: 12 months
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 8 Jan 2024.
- Individual participant dataSharing planned: No
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 Anterior and posterior treatment strategy and Simple posterior approach treatment strategy in people with Irreducible Atlantoaxial Dislocation, run by Peking University Third 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 3 inclusion and 3 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 8 Jan 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. 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 Shenglin Wang, MD (+86 13501380281, pkuwsl@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Decompression Rate (time frame: 12 months). The study lists 3 primary outcomes in all. 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 8 Jan 2024.