A Prospective Cohort Study of for Surgical Treatment of Irreducible Atlantoaxial Dislocation

Not yet recruiting

• Conditions: Atlantoaxial Dislocation
• Interventions: Procedure: Posterior intra-articular distraction and fusion; Procedure: Anterior transoral release and posterior cantilever reduction and fusion; Procedure: TARP

• Registration Number: NCT05978375
• Lead Sponsor: Xuanwu Hospital, Beijing

Brief Summary

The management of irreducible 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 prospective 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: 2023-07-30
• Study First Posted: 2023-08-07
• Last Update Submitted: 2023-08-20
• Last Update Posted: 2023-08-23
• Study Start: 2023-09-01
• Primary Completion: 2025-09-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Irreducible Atlantoaxial Dislocation	Anterior transoral release and posterior cantilever reduction and fusion	Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight.
Irreducible Atlantoaxial Dislocation	Posterior intra-articular distraction and fusion	Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight.
Irreducible Atlantoaxial Dislocation	TARP	Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight.

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