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Posterior Compression Distraction Reduction Technique System in the Treatment of BI-AAD (PCDR-BIAAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070743
Recruitment Status : Unknown
Verified October 2016 by Xuanwu Hospital, Beijing.
Recruitment status was:  Recruiting
First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Collaborators:
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Zhengzhou University
Southern Medical University, China
Information provided by (Responsible Party):
Xuanwu Hospital, Beijing

Brief Summary:
Posterior compression distraction reduction technique (PCDR) in the treatment of Basilar invagination associated with atlantoaxial dislocation

Condition or disease Intervention/treatment
Basilar Invagination Associated With Atlantoaxial Dislocation Procedure: Posterior Approach Compression Distraction Reduction Surgery

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2015
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations

Group/Cohort Intervention/treatment
PCDR surgery
Posterior Approach Compression Distraction Reduction Surgery is performed.All of patients received this procedure routinely in the department of neurosurgery at Xuanwu Hospital.
Procedure: Posterior Approach Compression Distraction Reduction Surgery
Posterior Approach Compression Distraction Reduction Surgery is performed.All of patients received this procedure routinely in the department of neurosurgery at Xuanwu Hospital.




Primary Outcome Measures :
  1. Storiation of dislocation confirmed by CT and MRI [ Time Frame: 1 yr ]
  2. Firmed bone graft fusion identified by CT [ Time Frame: 1 yr ]
  3. all cause mortality [ Time Frame: 1 yr ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Admitted to the hospital Diagnosed of basilar invagination accompanied with atlantooccipital dislocation.
Criteria

Inclusion Criteria:

  • CT indicated C0-C1 fusion, ADI>=3mm, CL>=3MM
  • 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
  • Accompanied with Chiari malformation needed to be decompression
  • Perinatal stage
  • With mortal diseases
  • Without ability to sign papers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070743


Contacts
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Contact: ZAN CHEN, MD +8613911712120 chenzan66@163.com
Contact: Wanru Duan, MD 13581803400 moored@qq.com

Locations
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China, Beijing
BEIJING Recruiting
Beijing, Beijing, China
Contact: Zan Chen, MD    13911712120 ext +86    13911712120@163.COM   
Sponsors and Collaborators
Xuanwu Hospital, Beijing
The Second Hospital of Hebei Medical University
The First Affiliated Hospital of Zhengzhou University
Southern Medical University, China
Investigators
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Study Chair: Zan Chen, MD Neurosurgery department, Xuanwu Hospital
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Responsible Party: Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03070743    
Other Study ID Numbers: XW-NS-PCDR
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Xuanwu Hospital, Beijing:
basilar invagination
atlantoaxial dislocation
surgery
restoration technique
Additional relevant MeSH terms:
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Joint Dislocations
Intussusception
Joint Diseases
Musculoskeletal Diseases
Wounds and Injuries
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases