Skip to content

Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation

A Randomized Controlled Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06003491
Enrollment
164
Registered
2023-08-22
Start date
2023-09-01
Completion date
2025-09-01
Last updated
2023-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atlantoaxial Dislocation

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.

Interventions

DEVICEIntra-articular Cages

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

Sponsors

Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Fusion Rates12 monthsAtlantoaixal fusion rates

Secondary

MeasureTime frameDescription
Japanese Orthopaedic Association Scores12 months0-17 Scores
Visual Analogue Scale12 months0-10 Scores
Neck Disability Index12 months0-5 Scores

Contacts

Primary ContactZan Chen, MD
chenzan66@163.com+8613911712120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026