Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation

NCT ID: NCT06003491

Last Updated: 2023-08-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-09-01

Brief Summary

The management of reducible atlantoaxial dislocation associated is challenging. Direct posterior distraction technique we proposed in 2010 could achieve satisfactory reduction. In 2020, we modified this technique and proposed a posterior intra-articular distraction technique. The intra-articular distraction technique could theoretically achieve satisfactory reduction and fusion. However, its superiority has not been proven. Therefore, we design a RCT study to compare the reduction rate and fusion rate of different strategies.

Conditions

Atlantoaxial Dislocation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intra-articular Group

Posterior intra-articular distraction and fusion

Group Type: EXPERIMENTAL

Intra-articular Cages

Intervention Type: DEVICE

Using reduction using posterior intra-articular distraction and fusion technique with cages.

Posterior Group

Posterior direct distraction and fusion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intra-articular Cages

Using reduction using posterior intra-articular distraction and fusion technique with cages.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• CT indicated atlantoaxial dislocation Agree with the operation plan Agree to be followed up

Exclusion Criteria

• The pathology is traumatic or RA Underwent operations in occipital-cervical region before With mortal diseases Without ability to sign papers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Zan Chen, MD

Role: CONTACT

chenzan66@163.com

+8613911712120

References

Chen Z, Duan W, Chou D, Guan J, Liu Z, Jian Q, Zhang B, Bo X, Jian F. A Safe and Effective Posterior Intra-Articular Distraction Technique to Treat Congenital Atlantoaxial Dislocation Associated With Basilar Invagination: Case Series and Technical Nuances. Oper Neurosurg. 2021 Mar 15;20(4):334-342. doi: 10.1093/ons/opaa391.

Reference Type: BACKGROUND

PMID: 33372978 (View on PubMed)

Other Identifiers

XW-NS-RCTRAAD

Identifier Type: -

Identifier Source: org_study_id