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

Sponsor

Xuanwu Hospital, Beijing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05978375

Collaborator

(none)

100

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atlantoaxial Dislocation	Procedure: Posterior intra-articular distraction and fusion Procedure: Anterior transoral release and posterior cantilever reduction and fusion Procedure: TARP

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Irreducible Atlantoaxial Dislocation Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight.	Procedure: Posterior intra-articular distraction and fusion Using reduction using posterior intra-articular distraction and fusion technique. Procedure: Anterior transoral release and posterior cantilever reduction and fusion Using anterior transoral release and posterior cantilever reduction and fusion technique. Procedure: TARP Using TARP technique.

Arm

Intervention/Treatment

Irreducible Atlantoaxial Dislocation

Atlantoaxial dislocation which could not be reducted under anesthesia traction with 1/6 weight.

Procedure: Posterior intra-articular distraction and fusion

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

Procedure: Anterior transoral release and posterior cantilever reduction and fusion

Using anterior transoral release and posterior cantilever reduction and fusion technique.

Procedure: TARP

Using TARP technique.

Outcome Measures

Primary Outcome Measures

Fusion Rates [12 months]
Atlantoaixal fusion rates

Secondary Outcome Measures

JOA [12 months]
JOA Score
VAS [12 months]
VAS Score
NDI [12 months]
NDI Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

NCT05978375

Other Study ID Numbers:

XW-NS-PROIAAD

First Posted:

Aug 7, 2023

Last Update Posted:

Aug 7, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Joint Dislocations

Study Results

No Results Posted as of Aug 7, 2023