Minimally Invasive Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF) As a Surgical Treatment of Atlantoaxial Dislocation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion, Open atlantoaxial fixation and fusion.
- Who it may be relevant to
- Registry conditions: Atlantoaxial Dislocation. Basic parameters: 0 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Study of Minimally Invasive Atlantoaxial Mass Fusion and Open Atlantoaxial Fusion in the Treatment of Atlantoaxial Dislocation
Overview
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.
Interventions
- Procedure minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion
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. - Procedure Open atlantoaxial fixation and fusion
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.
Primary outcome measures
- Perioperative Blood Loss [Time frame: 2 weeks]
- Postoperative Stay [Time frame: 2 weeks]
- Level of Occipitocervical Pain [Time frame: 12 months]
- Main location of occipitocervical pain [Time frame: 12 months]
- Painkillers Used for Occipitocervical Pain [Time frame: 12 months]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Atlantoaxial dislocation without surgical treatment
- Atlantoaxial dislocation treated by other operation, such as TARP
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT06678711 · M2024730