Atlantoaxial DislocationNCT06678711
Minimally Invasive Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF) As a Surgical Treatment of Atlantoaxial Dislocation
A study testing minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion and Open atlantoaxial fixation and fusion in people with Atlantoaxial Dislocation, run by Peking University Third Hospital at 1 site in China.
Trial summary
The conventional treatment for atlantoaxial dislocation is atlantoaxial fixation and fusion using the Goel-Harms technique, which involves a midline incision, dissection of the occipital muscle group, and is associated with disadvantages such as damage to the posterior ligament and muscle, high incidence of… Read more about this study
- Who is it for?
- Ages 0 to 80 years
- Conditions the study is for
- Atlantoaxial Dislocation
- What is being tested?
- minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion and Open atlantoaxial fixation and fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2024to 30 Jun 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 0 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age range from 0 to 80 years old, regardless of gender
- Diagnosed with atlantoaxial dislocation, suitable for posterior surgical treatment
- Index of assessment integrity
- Agree to participate in the study and sign the informed consent
Who cannot join
- Atlantoaxial dislocation without surgical treatment
- Atlantoaxial dislocation treated by other operation, such as TARP
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Shenglin Wang, MD, +86 13501380281, pkuwsl@126.com
Qiyue Gao, MD, +86 13811631230, x2455960615@163.com
About this study
Official title: Randomized Controlled Study of Minimally Invasive Atlantoaxial Mass Fusion and Open Atlantoaxial Fusion in the Treatment of Atlantoaxial Dislocation
The conventional treatment for atlantoaxial dislocation is atlantoaxial fixation and fusion using the Goel-Harms technique, which involves a midline incision, dissection of the occipital muscle group, and is associated with disadvantages such as damage to the posterior ligament and muscle, high incidence of postoperative occipital cervical pain, and significant blood loss due to intraoperative bleeding and postoperative drainage. Since 2013, various studies have reported minimally invasive posterior atlantoaxial lateral mass joint fusion techniques through muscle spaces, but previous studies were all case reports, without sufficient reliability and controlled studies. The Department of Orthopedics at Peking University Third Hospital has been using the minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion (Mis-PALF) technique for the treatment of atlantoaxial dislocation since 2015, with preliminary good clinical results. In order to further compare the advantages and disadvantages of the two surgical methods from a larger sample, a randomized controlled study is planned. The patients will be randomly divided into two groups, with the experimental group receiving the Mis-PALF surgery and the control group receiving open atlantoaxial fusion and fixation. There will be a 1-2 year follow-up to compare the safety and effectiveness of the two surgical methods for the treatment of atlantoaxial dislocation.
- Conditions
- Atlantoaxial Dislocation
- Being tested
- minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion, Open atlantoaxial fixation and fusion
- Keywords
- atlantoaxial dislocation, MIS-PALF, minimal invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimal invasive surgery-posterior atlantoaxial lateral mass joint fusionProcedure or surgery
Make a 4.5 cm incision along the median line and then dissect the trapezius, splenius capitis, and semispinalis capitis muscle laterally 1.5 cm off the median line. Retract the obliquus capitis inferior muscle to expose the C1-C2 intra-articular space. Remove the articular cartilage, insert allogenic granular bone and 3D-printed cage. Place the screws and rod in the same positions as conventional surgery, and the operation is completed.
Open atlantoaxial fixation and fusionProcedure or surgery
The Goel-Harms procedure will be used in the control group. Screws and rods are placed in the same position as in the experimental group, and a negative-pressure drain was placed until daily drainage was <50 mL.
| Study group | Role | What they receive |
|---|---|---|
| Minimal invasive surgery arm | Experimental | Patients in minimal invasive surgery arm will receive minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion. Receives: Procedure: minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion |
| Open atlantoaxial fixation and fusion arm | Active comparator | Patients in open atlantoaxial fixation and fusion arm will receive atlantoaxial fixation and fusion using the Goel-Harms technique. Receives: Procedure: Open atlantoaxial fixation and fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Blood Loss
Blood loss due to intraoperative bleeding and postoperative drainage.
Measured: 2 weeks
Postoperative Stay
The time from the completion of surgery to the patient leaving hospital.
Measured: 2 weeks
Level of Occipitocervical Pain
The level of patients' occipitocervical pain is described by Numerical Rating Scale, from zero to ten, and ten means the most pain.
Measured: 12 months
Main location of occipitocervical pain
The location of patients' occipitocervical pain is indicated by patients on a diagram illustrating the anatomical regions of the head and neck.
Measured: 12 months
Painkillers Used for Occipitocervical Pain
Patients are asked about whether they used any painkillers for occipitocervical pain and which painkillers they used.
Measured: 12 months
Secondary outcomes (5)
Incidence of Adverse Events
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
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
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
Improvement Rate of Quality of Life
The quality of life for each patient will be assessed using the Short Form 12-Item(SF-12) Health Survey. SF-12 scores ranges from 0 to 100, and 100 usually means healthier in a certain dimension. 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' Japanese Orthopaedic Association(JOA) scores one year after surgery will be compared with their preoperative scores. JOA score ranges form 0 to 17, and 0 means worse neurological function. 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 posted7 Nov 2024
- Study start4 Nov 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hebei Medical University Third Hospital, Shanxi Bethune Hospital, 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, Daping Hospital of Army Medical University, Shengjing Hospital, Third Bethune Hospital of Jilin University
- Responsible party
- Principal investigator, Wang Shenglin, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06678711
- Sponsor's protocol ID
- M2024730
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2024
- Last updated
- 7 Nov 2024
- 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 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Minimally Invasive Atlantoaxial Mass Fusion and Open Atlantoaxial Fusion in the Treatment of Atlantoaxial Dislocation
- ClinicalTrials.gov ID
- NCT06678711
- Acronym / sponsor ID
- M2024730
- Conditions
- Atlantoaxial Dislocation
- Keywords
- atlantoaxial dislocation, MIS-PALF, minimal invasive surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Hebei Medical University Third Hospital, Shanxi Bethune Hospital, 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, Daping Hospital of Army Medical University, Shengjing Hospital, Third Bethune Hospital of Jilin University
- Study start
- 4 Nov 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Nov 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.
The conventional treatment for atlantoaxial dislocation is atlantoaxial fixation and fusion using the Goel-Harms technique, which involves a midline incision, dissection of the occipital muscle group, and is associated with disadvantages such as damage to the posterior ligament and muscle, high incidence of postoperative occipital cervical pain, and significant blood loss due to intraoperative bleeding and postoperative drainage. Since 2013, various studies have reported minimally invasive posterior atlantoaxial lateral mass joint fusion techniques through muscle spaces, but previous studies were all case reports, without sufficient reliability and controlled studies. The Department of Orthopedics at Peking University Third Hospital has been using the minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion (Mis-PALF) technique for the treatment of atlantoaxial dislocation since 2015, with preliminary good clinical results. In order to further compare the advantages and disadvantages of the two surgical methods from a larger sample, a randomized controlled study is planned. The patients will be randomly divided into two groups, with the experimental group receiving the Mis-PALF surgery and the control group receiving open atlantoaxial fusion and fixation. There will be a 1-2 year follow-up to compare the safety and effectiveness of the two surgical methods for the treatment of atlantoaxial dislocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimal invasive surgery arm | Experimental | Procedure: minimal invasive surgery-posterior atlantoaxial lateral mass joint fusionPatients in minimal invasive surgery arm will receive minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion. |
| Open atlantoaxial fixation and fusion arm | Active comparator | Procedure: Open atlantoaxial fixation and fusionPatients in open atlantoaxial fixation and fusion arm will receive atlantoaxial fixation and fusion using the Goel-Harms technique. |
Who may qualify
- Ages
- 0 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Age range from 0 to 80 years old, regardless of gender
- Diagnosed with atlantoaxial dislocation, suitable for posterior surgical treatment
- Index of assessment integrity
- Agree to participate in the study and sign the informed consent
Key exclusion criteria (2 listed)
- Atlantoaxial dislocation without surgical treatment
- Atlantoaxial dislocation treated by other operation, such as TARP
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 |
|---|---|---|
| minimal invasive surgery-posterior atlantoaxial lateral mass joint fusionMake a 4.5 cm incision along the median line and then dissect the trapezius, splenius capitis, and semispinalis capitis muscle laterally 1.5 cm off the median line. Retract the obliquus capitis inferior muscle to expose the C1-C2 intra-articular space. Remove the articular cartilage, insert allogenic granular bone and 3D-printed cage. Place the screws and rod in the same positions as conventional surgery, and the operation is completed. | Procedure or surgery | Minimal invasive surgery arm |
| Open atlantoaxial fixation and fusionThe Goel-Harms procedure will be used in the control group. Screws and rods are placed in the same position as in the experimental group, and a negative-pressure drain was placed until daily drainage was <50 mL. | Procedure or surgery | Open atlantoaxial fixation and fusion arm |
Primary outcome
Perioperative Blood Loss
Time frame: 2 weeks
Blood loss due to intraoperative bleeding and postoperative drainage.
Postoperative Stay
Time frame: 2 weeks
The time from the completion of surgery to the patient leaving hospital.
Level of Occipitocervical Pain
Time frame: 12 months
The level of patients' occipitocervical pain is described by Numerical Rating Scale, from zero to ten, and ten means the most pain.
Main location of occipitocervical pain
Time frame: 12 months
The location of patients' occipitocervical pain is indicated by patients on a diagram illustrating the anatomical regions of the head and neck.
Painkillers Used for Occipitocervical Pain
Time frame: 12 months
Patients are asked about whether they used any painkillers for occipitocervical pain and which painkillers they used.
5 secondary outcomes
Incidence of Adverse Events
Time frame: 12 months
Atlantoaxial Reduction Rate
Time frame: 12 months
Bone Graft Fusion Rate
Time frame: 12 months
Improvement Rate of Quality of Life
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 7 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion and Open atlantoaxial fixation and fusion in people with 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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 7 Nov 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 Qiyue Gao, MD (+86 13811631230, x2455960615@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Blood Loss (time frame: 2 weeks). The study lists 5 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 7 Nov 2024.