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

NCT ID: NCT06678711

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2026-06-30

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.

Conditions

Atlantoaxial Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Minimal invasive surgery arm

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

Group Type: EXPERIMENTAL

minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion

Intervention Type: PROCEDURE

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 fusion arm

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

Group Type: ACTIVE_COMPARATOR

Open atlantoaxial fixation and fusion

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Third Hospital

OTHER

Sponsor Role: collaborator

Shanxi Bethune Hospital

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: collaborator

Tianjin People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

Daping Hospital of Army Medical University

OTHER

Sponsor Role: collaborator

Shengjing Hospital

OTHER

Sponsor Role: collaborator

Third Bethune Hospital of Jilin University

UNKNOWN

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wang Shenglin

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Qiyue Gao, MD

Role: CONTACT

x2455960615@163.com

+86 13811631230

Shenglin Wang, MD

Role: CONTACT

pkuwsl@126.com

+86 13501380281

Facility Contacts

Shenglin Wang, MD

Role: primary

pkuwsl@126.com

+86 13501380281

Qiyue Gao, MD

Role: backup

x2455960615@163.com

+86 13811631230

Other Identifiers

M2024730

Identifier Type: -

Identifier Source: org_study_id