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Basilar Invagination Associated With Atlantoaxial DislocationPCDR-BIAADNCT03070743

Posterior Compression Distraction Reduction Technique System in the Treatment of BI-AAD

An observational study of Basilar Invagination Associated With Atlantoaxial Dislocation, run by Xuanwu Hospital, Beijing at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Posterior compression distraction reduction technique (PCDR) in the treatment of Basilar invagination associated with atlantoaxial dislocation Read more about this study

Who is it for?
Ages 18 to 72 years
What is being tested?
Posterior Approach Compression Distraction Reduction Surgery
Type of treatment
Surgery or procedure
How many people
20 participants
Where
1 siteChina
Study dates
Jul 2015to Aug 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 72 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Admitted to the hospital Diagnosed of basilar invagination accompanied with atlantooccipital dislocation.

Who may be able to join

  • CT indicated C0-C1 fusion, ADI>=3mm, CL>=3MM
  • Agree with the operation plan
  • Agree to be followed up

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Wanru Duan, MD contact

13581803400

moored@qq.com

China1 site, 1 recruiting
  • BEIJING

    Beijing, Beijing Municipality

    Zan Chen, MD, 13911712120 ext. +86, 13911712120@163.COM

    Recruiting

Other trials in China

About this study

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

Read the detailed description

Basilar invagination (BI) refers to the skull base into the direction of cervical spine, mainly to the odontoid process into the foramen magnum is a major change of congenital cranial vertebral junction malformation. Different from trauma or inflammatory lesions, there exists not only in horizontal but also vertical direction dislocation between atlas and axis,At present there is no satisfactory and widely accepted operation method. At present, the main treatment strategy is adopt skull traction to patients preoperative or intraoperative and make vertebra X-ray observation. If the skull traction restored the atlanto-axial dislocation, This case belongs to restorable atlanto-axial dislocation. If the skull traction cannot restore the dislocation, that is non-restorable atlanto-axial dislocation. For the restorable type, posterior occipital cervical internal fixation and fusion should be performed. For the non restorable cases, the main theories is that various ligaments and scars is formed between the anterior arch of atlas and the odontoid process lead to the causes of the longitudinal traction, so transoral anterior atlanto-axial joint lysis is needed first, and then adopt posterior occipital-cervical internal fixation and interbody fusion after the atlanto-axial dislocation is restored. Because the anterior trans-oral atlanto-axial joint lysis has weakness of difficult and high risk, it has limit the popularization of the treatment of atlanto-axial dislocation. Currently only a few several spinal surgery centers have the ability to carry out. Another problem of this treatment strategy is that the function of posterior operation confined to occipital-cervical fixation in situ but not considered the try to adopt the posterior open reduction, this is mainly due to the current clinical application of occipital cervical posterior fixation system be lack of the pressure reduction effect.

Abumi proposed posterior operation incision, atlanto-axial restore intraoperative technique in 1999, and designed the first compression screw that has a restore function in the operation. But it hasn't been widely used because of the intraoperative reposition and internal fixation instrument design is not reasonable and the restore technique has a lot of deficiencies In 2006 Wangchao reported another posterior atlanto-axial dislocation reduction technology. The restore direction of this technology is more reasonable than Abumi's, but the occipital titanium plate adopted in this kind of restore technique is still evolved the occipital-cervical internal fixation system designed by Abumi, just have the mechanical properties of restore level atlanto-axial dislocation. but for atlanto-axial dislocation caused by the Basilar invagination is still need to adopt restore by skull traction. And in many cases also need to perform anterior transoral atlanto-axial joint lysis in order to achieve expected reduction effect.

Wangchao adopt the same occipital-cervical internal fixation system as Abumi technique to perform pressure reduction of atlanto-axial dislocation. This technology is more reasonable in the pressing direction. Using the occipital-cervical internal fixation system was same as Abumi technique it doesn't own the function of Distraction reduction. Therefore for the vertical dislocation of atlanto-axial Still need to restore by skull traction, some patients need the anterior transoral atlanto-axial joint lysis to restore by traction.

In 2010 the members of the project group reported the atlanto-axial dislocation restore by simple posterior screw internal fixation technique and has achieved effect. The investigator can restore vertical dislocation between the atlanto-axial effectively by applying distraction force between occipital screws and axis pedicle screws. For those Basilar Invagination (BI) complicated with Atlanto-axial dislocation(AAD), the rate of Atlanto-axial reduction100% reached 65%. But due to the use of internal fixation system is ordinary occipital cervical internal fixation system (Summit system,DePuy Co) lacking of the function pressure reduction, therefore the effect of level reduction of atlanto-axial dislocation is poor. In some cases it induct atlanto-axial joint rearward opening angle increases, odontoid falling backwards aggregately, the medulla spinal cord angle narrowed further.Furthermore, Part of the reasons why atlanto occipital complex malformation patients failed to achieve 100% reduction is that atlanto-axial lateral is deformities seriously, utual locking, it is difficulty to restore by this technology.

The technology divided intraoperative reduction process into two operating. First of all, restore the level of dislocation between atlanto-axial through pressure, and then restore the vertical dislocation between atlanto-axial through distraction. The investigator designed the compression occipital plate (COP) owned functions both compression and distraction reduction in order to make it convenient in intraoperative technical operation. The investigation report of Patent Bureau indicated that the design of this type of titanium plate is creative and novel.

The clinical application of this technique has achieved initial success in the treatment of basilar invagination complicated with atlanto-axial dislocation patients. This technology so far is the most reasonable posterior reduction technology in the treatment of basilar invagination complicated with atlanto-axial dislocation mechanics mechanism.

Although the compression distraction reduction technology has obvious advantages analyzed from the mechanical properties of angle application of pressurized occipital titanium plate, but if the application of this technology can be safely effective cure basilar invagination and atlanto-axial dislocation patients, improve neurological function, still need further prospective clinical study.

Being tested
Posterior Approach Compression Distraction Reduction Surgery
Keywords
basilar invagination, atlantoaxial dislocation, surgery, restoration technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Posterior Approach Compression Distraction Reduction SurgeryProcedure or surgery

    Posterior Approach Compression Distraction Reduction Surgery is performed.All of patients received this procedure routinely in the department of neurosurgery at Xuanwu Hospital.

Study groups in NCT03070743
Study groupRoleWhat they receive
PCDR surgeryPosterior Approach Compression Distraction Reduction Surgery is performed.All of patients received this procedure routinely in the department of neurosurgery at Xuanwu Hospital.
Receives: Procedure: Posterior Approach Compression Distraction Reduction Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Storiation of dislocation confirmed by CT and MRI

    Measured: 1 yr

  2. Firmed bone graft fusion identified by CT

    Measured: 1 yr

  3. all cause mortality

    Measured: 1 yr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2017
  2. Study startJul 2015
  3. Primary completionJul 2017 (estimated)
  4. Study completionAug 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03070743
Sponsor's protocol ID
XW-NS-PCDR
Acronym
PCDR-BIAAD
Status last verified
Oct 2016
First submitted
25 Oct 2016
Last updated
6 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Basilar Invagination Associated With Atlantoaxial Dislocation, run by Xuanwu Hospital, Beijing at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact ZAN CHEN, MD (+8613911712120, chenzan66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Storiation of dislocation confirmed by CT and MRI (time frame: 1 yr). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.

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