The Treatment of Refractory Atlantoaxial Dislocation

Sponsor

Peking University Third Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05847270

Collaborator

(none)

600

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

At present, the selection of surgical strategies for the treatment of atlantoaxial dislocation is often based on the surgeon's own experience and the choice of different methods. However, there is a lack of standardized, large-scale, and high-level evidence-based medicine research on the safety and effectiveness of empirical treatment at present. Based on this, this study intends to use a prospective randomized controlled study to explore surgical strategies for refractory atlantoaxial dislocation. And long-term follow-up will be conducted on patients to evaluate the safety and effectiveness of different surgical methods, and to develop diagnostic and treatment standards for refractory atlantoaxial dislocation.

Condition or Disease	Intervention/Treatment	Phase
Refractory Atlantoaxial Dislocation Surgical Strategies	Procedure: Anterior oral release+posterior fixation fusion	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Study on the Treatment of Refractory Atlantoaxial Dislocation

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Dec 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anterior oral release+posterior fixation fusion Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is difficult to restore the dislocation, a technique of anterior oral release and posterior fixation fusion was used for reduction. Bone grafting was performed between lateral masses or intervertebral plates;	Procedure: Anterior oral release+posterior fixation fusion Anterior and posterior treatment strategy: Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is difficult to restore the dislocation, a technique of anterior oral release and posterior fixation fusion was used for reduction, and bone grafting was used between lateral masses or intervertebral plates;
Active Comparator: posterior treatment strategy Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is a difficult to restore dislocation, specialized instruments were used to release the atlantoaxial joint based on the shape of the patient's atlantoaxial joint. A fusion device with appropriate angle and height was placed between the atlantoaxial joints through a posterior approach for direct reduction. The bone grafting method used was intra articular fusion or posterolateral bone grafting.	Procedure: Anterior oral release+posterior fixation fusion Anterior and posterior treatment strategy: Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is difficult to restore the dislocation, a technique of anterior oral release and posterior fixation fusion was used for reduction, and bone grafting was used between lateral masses or intervertebral plates;

Arm

Intervention/Treatment

Experimental: Anterior oral release+posterior fixation fusion

Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is difficult to restore the dislocation, a technique of anterior oral release and posterior fixation fusion was used for reduction. Bone grafting was performed between lateral masses or intervertebral plates;

Procedure: Anterior oral release+posterior fixation fusion

Anterior and posterior treatment strategy: Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is difficult to restore the dislocation, a technique of anterior oral release and posterior fixation fusion was used for reduction, and bone grafting was used between lateral masses or intervertebral plates;

Active Comparator: posterior treatment strategy

Before surgery, a large weight traction of 1/6 body weight was used to determine the reversibility of atlantoaxial dislocation. After determining that it is a difficult to restore dislocation, specialized instruments were used to release the atlantoaxial joint based on the shape of the patient's atlantoaxial joint. A fusion device with appropriate angle and height was placed between the atlantoaxial joints through a posterior approach for direct reduction. The bone grafting method used was intra articular fusion or posterolateral bone grafting.

Procedure: Anterior oral release+posterior fixation fusion

Outcome Measures

Primary Outcome Measures

Adverse event occurrence rate [12 month follow up]
The proportion of patients with adverse events during the study period to the number of study patients. Adverse events include neurological deterioration, incision infection, vascular injury, airway obstruction, poor reduction, unplanned readmission and surgery, internal fixation failure, fusion failure, and surgical related lower cervical spine deformities

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age range from 0 to 80 years old, regardless of gender;
According to preoperative imaging and skull traction evaluation with a weight of 1/6 after anesthesia, patients diagnosed as refractory atlantoaxial dislocation were treated surgically;
Sign an informed consent form;
Patients who can choose between simple posterior reduction and fixation or combined anterior and posterior reduction and fixation.

Exclusion Criteria:

Atlantoaxial dislocation without surgical treatment
Patients who refuse to participate in this project

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wang Shenglin, Clinical Professor, Peking University Third Hospital

ClinicalTrials.gov Identifier:

NCT05847270

Other Study ID Numbers:

M2023203

First Posted:

May 6, 2023

Last Update Posted:

May 10, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Joint Dislocations

Study Results

No Results Posted as of May 10, 2023