Minimally Invasive Atlantoaxial Lateral Mass Joint Fusion (MIS-PALF) As a Surgical Treatment of Atlantoaxial Dislocation

Peking University

Status: Not yet enrolling

Conditions: Atlantoaxial Dislocation

Treatments: Procedure: minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion; Procedure: Open atlantoaxial fixation and fusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06678711

M2024730

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age range from 0 to 80 years old, regardless of gender
2. Diagnosed with atlantoaxial dislocation, suitable for posterior surgical treatment
3. Index of assessment integrity
4. Agree to participate in the study and sign the informed consent

Exclusion criteria

1. Atlantoaxial dislocation without surgical treatment
2. Atlantoaxial dislocation treated by other operation, such as TARP

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Minimal invasive surgery arm

Experimental group

Description:

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

Treatment:

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

Open atlantoaxial fixation and fusion arm

Active Comparator group

Description:

Patients in open atlantoaxial fixation and fusion arm will receive atlantoaxial fixation and fusion using the Goel-Harms technique.

Treatment:

Procedure: Open atlantoaxial fixation and fusion