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

NCT06678711 | Not Yet Recruiting DMC

• 1 other identifier: M2024730
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

atlantoaxial dislocation; MIS-PALF; minimal invasive surgery

Outcome Measures

Primary Outcomes (5)

• Perioperative Blood Loss

  Blood loss due to intraoperative bleeding and postoperative drainage.

  2 weeks

• Postoperative Stay

  The time from the completion of surgery to the patient leaving hospital.

  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.

  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.

  12 months

• Painkillers Used for Occipitocervical Pain

  Patients are asked about whether they used any painkillers for occipitocervical pain and which painkillers they used.

  12 months

Secondary Outcomes (5)

• 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

Study Arms (2)

Minimal invasive surgery arm

EXPERIMENTAL

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

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.

Procedure: Open atlantoaxial fixation and fusion

Interventions

minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion 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.

Minimal invasive surgery arm

Open atlantoaxial fixation and fusion 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.

Open atlantoaxial fixation and fusion arm

Eligibility Criteria

• Age: 0 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Atlantoaxial dislocation without surgical treatment
• Atlantoaxial dislocation treated by other operation, such as TARP

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Hebei Medical University Third Hospital: collaborator
• Shanxi Bethune Hospital: collaborator
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Tianjin People's Hospital: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• Daping Hospital of Army Medical University: collaborator
• Shengjing Hospital: collaborator
• The Third Bethune Hospital of Jilin University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Gene Fusion

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Central Study Contacts

Qiyue Gao, MD

CONTACT

+86 13811631230; x2455960615@163.com

Shenglin Wang, MD

CONTACT

+86 13501380281; pkuwsl@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 7, 2024
• Study Start: November 4, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)