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NCT06678711

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

Not yet recruiting NA Last updated 7 November 2024
What this trial tests

NA trial testing minimal invasive surgery-posterior atlantoaxial lateral mass joint fusion in Atlantoaxial Dislocation in 60 participants. Not yet recruiting.

Timeline
4 November 2024
Primary endpoint
30 June 2025
30 June 2026

Quick facts

Lead sponsorPeking University Third Hospital
PhaseNA
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment60
Start date4 November 2024
Primary completion30 June 2025
Estimated completion30 June 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking University Third Hospital

Who can join

Adults 0 to 80, any sex, with Atlantoaxial Dislocation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Atlantoaxial Dislocation

Currently open trials in the same condition.

Other Peking University Third Hospital trials

Trials by the same sponsor.

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Data sources for this page

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