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

NCT05978375 | Unknown

• 1 other identifier: XW-NS-PROIAAD
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

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 (1)

Irreducible Atlantoaxial Dislocation

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

Procedure: Posterior intra-articular distraction and fusion; Procedure: Anterior transoral release and posterior cantilever reduction and fusion; Procedure: TARP

Interventions

Posterior intra-articular distraction and fusion PROCEDURE

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

Irreducible Atlantoaxial Dislocation

Anterior transoral release and posterior cantilever reduction and fusion PROCEDURE

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

Irreducible Atlantoaxial Dislocation

TARP PROCEDURE

Using TARP technique.

Irreducible Atlantoaxial Dislocation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

18-70, exclude traumatic, RA and previous surgery.

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

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

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: 33372978 BACKGROUND

MeSH Terms

Interventions

Gene Fusion; TARP

Intervention Hierarchy (Ancestors)

Recombination, Genetic; Genetic Phenomena

Central Study Contacts

Zan Chen, MD

CONTACT

+8613911712120; chenzan66@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 7, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 23, 2023

Record last verified: 2023-07