NCT06003491

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

August 22, 2023

Status Verified

July 1, 2023

Enrollment Period

Same day

First QC Date

July 30, 2023

Last Update Submit

August 20, 2023

Conditions

Atlantoaxial Dislocation

Outcome Measures

Primary Outcomes (1)

  • Fusion Rates

    Atlantoaixal fusion rates

    12 months

Secondary Outcomes (3)

  • Japanese Orthopaedic Association Scores

    12 months

  • Visual Analogue Scale

    12 months

  • Neck Disability Index

    12 months

Study Arms (2)

Intra-articular Group

EXPERIMENTAL

Posterior intra-articular distraction and fusion

Device: Intra-articular Cages

Posterior Group

NO INTERVENTION

Posterior direct distraction and fusion

Interventions

Intra-articular CagesDEVICE

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

Intra-articular Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33372978BACKGROUND

Central Study Contacts

Zan Chen, MD

CONTACT

+8613911712120chenzan66@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2023

First Posted

August 22, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 1, 2025

Last Updated

August 22, 2023

Record last verified: 2023-07