Allogeinic Bone Paste (NCT04605120) | Clinical Trial Compass
UnknownNot Applicable
Allogeinic Bone Paste
France50 participantsStarted 2020-09-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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