Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation

Not Applicable

Not yet recruiting

• Conditions: Atlantoaxial Dislocation

• Registration Number: NCT06003491
• Lead Sponsor: Xuanwu Hospital, Beijing

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-08-20
• Last Update Submitted: 2023-08-20
• Study First Posted: 2023-08-22
• Last Update Posted: 2023-08-22
• Study Start: 2023-09-01
• Primary Completion: 2023-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 164

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fusion Rates	12 months	Atlantoaixal fusion rates

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	12 months	0-10 Scores
Japanese Orthopaedic Association Scores	12 months	0-17 Scores
Neck Disability Index	12 months	0-5 Scores