Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation

• Sponsor: Xuanwu Hospital, Beijing (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06003491
• Collaborator: (none)
• Enrollment: 164
• Arms: 2
• Anticipated Duration (Months): 24

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atlantoaxial Dislocation	Device: Intra-articular Cages	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intra-articular Group Posterior intra-articular distraction and fusion	Device: Intra-articular Cages; Using reduction using posterior intra-articular distraction and fusion technique with cages.
No Intervention: Posterior Group Posterior direct distraction and fusion

Outcome Measures

Primary Outcome Measures

1. Fusion Rates [12 months]

   Atlantoaixal fusion rates

Secondary Outcome Measures

1. Japanese Orthopaedic Association Scores [12 months]

   0-17 Scores

2. Visual Analogue Scale [12 months]

   0-10 Scores

3. Neck Disability Index [12 months]

   0-5 Scores

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Xuanwu Hospital, Beijing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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 (Hagerstown). 2021 Mar 15;20(4):334-342. doi: 10.1093/ons/opaa391.

• Responsible Party: Xuanwu Hospital, Beijing
• ClinicalTrials.gov Identifier: NCT06003491
• Other Study ID Numbers: XW-NS-RCTRAAD
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 22, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Joint Dislocations

Study Results

No Results Posted as of Aug 22, 2023