Allogeinic Bone Paste

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    50
  • sponsor
    Biobank
Updated on 26 January 2021

Summary

This is a prospective, single arm, single center clinical study to evaluate efficacy and safety of a Supercritical CO2 viral-inactivated allogenic bone paste in cervical interbody fusion. Patient eligible for 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft after failure of well-conducted medical treatment will be screened for the study.

Description

Cervical and lumbar fusion are often the best option for various degenerative conditions that do not respond to conservative treatment. Historically, the reference technique for cervical fusion was the use of iliac crest autogenic bone graft (ICBG). However, the use of ICBG has several drawbacks, including the morbidity of the donor site, the increase in operating time and the variable quality of autograft. Alternatives to ICBG for cervical fusion include the use of allografts, graft extensions and osteobiological materials to improve fusion rates.

This is a prospective, single arm, single center clinical study to evaluate efficacy and safety of a Supercritical CO2 viral-inactivated allogenic bone paste in cervical interbody fusion. Patient eligible for 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft after failure of well-conducted medical treatment will be screened for the study.

Subjects will be followed up postoperatively per standard of care at 3 months, 6 months, 12 and 24 months at the clinic. The following outcomes will be measured: overall success, Neck Disability Index (NDI), VAS neck and arm pain, SF-12 health survey, major complications, subsequent surgery rate, and fusion rate on radiological examinations. The primary endpoint is a FDA composite definition of success comprising clinical improvement and absence of major complications and secondary surgery events.

Details
Condition Spinal Fusion, Cervical Disc Degeneration, Cervical Fusion, cervical arthrodesis, cervical spine fusion, spinal fusions
Treatment Cervical fusion, Cervical fusion
Clinical Study IdentifierNCT04605120
SponsorBiobank
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged 18 years old
Patient eligible for anterior cervical fusion combined with bone graft after failure of well-conducted medical treatment
Arthrodesis performed on up to 2 levels and fused by one or more plates with an interbody cage on at least one level
Radicular signs and symptoms in one or both arms (i.e., pain, paresthesia, or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy
X-ray diagnosis of cervical herniated disc and/or osteophyte at 1 or 2 levels depending on clinical signs and symptoms, disc degeneration, trauma without neurological damage
Ability and willingness to comply with project requirements
Written informed consent given by the subject or the subject's legally authorized representative

Exclusion Criteria

Acute local or systemic infection
Women who are pregnant or in a desire to be pregnant or breast-feeding
Any contraindication to the proposed surgical procedure
Previous cervical surgery (either anterior or posterior)
Surgery performed over several operating times
Arthrodesis performed posteriorly or involving more than 2 levels or not requiring the use of a bone graft
Systemic disease, metabolic bone disease and autoimmune disease
Use of any known drug to potentially interfere with the healing of bones and soft tissues (corticosteroids or immunosuppressive agents...)
Any other concomitant medical disease or treatment that could significantly alter the normal healing process as assessed by the investigator
Neoplasm of the spine
Severe mental or psychiatric disorders
Any other condition that, in the investigator's view, would adversely affect patient safety or would not meet the requirements of the protocol
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note