Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation

Capital Medical University

Status: Not yet enrolling

Conditions: Atlantoaxial Dislocation

Treatments: Device: Intra-articular Cages

Study type: Interventional

Funder types: Other

Identifiers

NCT06003491

XW-NS-RCTRAAD

Details and patient eligibility

About

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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Intra-articular Group

Experimental group

Description:

Posterior intra-articular distraction and fusion

Treatment:

Device: Intra-articular Cages

Posterior Group

No Intervention group

Description:

Posterior direct distraction and fusion