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Clinical Trials/NCT06678711
NCT06678711Not yet recruitingNot Applicable

Randomized Controlled Study of Minimally Invasive Atlantoaxial Mass Fusion and Open Atlantoaxial Fusion in the Treatment of Atlantoaxial Dislocation

Peking University Third Hospital1 site in 1 country60 target enrollmentStarted: November 4, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
Perioperative Blood Loss

Study Overview

Brief 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 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
0 Years to 80 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Minimal invasive surgery arm

Experimental

Patients in minimal invasive surgery arm will receive minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion.

Intervention: minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion (Procedure)

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.

Intervention: Open atlantoaxial fixation and fusion (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Incidence of Adverse Events(12 months)
  • Atlantoaxial Reduction Rate(12 months)
  • Bone Graft Fusion Rate(12 months)
  • Improvement Rate of Quality of Life(12 months)
  • Improvement of Neurological Function(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Wang Shenglin

Clinical Professor

Peking University Third Hospital

Study Sites (1)

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