Trial for Surgical Treatment of Reducible Atlantoaxial Dislocation
Not Applicable
Not yet recruiting
- Conditions
- Atlantoaxial Dislocation
- Interventions
- Device: Intra-articular Cages
- Registration Number
- NCT06003491
- Lead Sponsor
- Xuanwu Hospital, Beijing
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 164
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intra-articular Group Intra-articular Cages Posterior intra-articular distraction and fusion
- Primary Outcome Measures
Name Time Method Fusion Rates 12 months Atlantoaixal fusion rates
- Secondary Outcome Measures
Name Time Method Visual Analogue Scale 12 months 0-10 Scores
Neck Disability Index 12 months 0-5 Scores
Japanese Orthopaedic Association Scores 12 months 0-17 Scores