Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-09-15
2023-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Allogeinic Bone Paste
Supercritical CO2 viral-inactivated allogeinic bone paste derived from human living donor femoral heads
Cervical fusion
1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft
Interventions
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Cervical fusion
1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft
Eligibility Criteria
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Inclusion Criteria
2. Patient eligible for anterior cervical fusion combined with bone graft after failure of well-conducted medical treatment.
3. Arthrodesis performed on up to 2 levels and fused by one or more plates with an interbody cage on at least one level
4. 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
5. 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
6. Ability and willingness to comply with project requirements
7. Written informed consent given by the subject or the subject's legally authorized representative
Exclusion Criteria
2. Women who are pregnant or in a desire to be pregnant or breast-feeding
3. Any contraindication to the proposed surgical procedure
4. Previous cervical surgery (either anterior or posterior)
5. Surgery performed over several operating times
6. Arthrodesis performed posteriorly or involving more than 2 levels or not requiring the use of a bone graft
7. Systemic disease, metabolic bone disease and autoimmune disease.
8. Use of any known drug to potentially interfere with the healing of bones and soft tissues (corticosteroids or immunosuppressive agents...)
9. Any other concomitant medical disease or treatment that could significantly alter the normal healing process as assessed by the investigator
10. Neoplasm of the spine
11. Severe mental or psychiatric disorders
12. Any other condition that, in the investigator's view, would adversely affect patient safety or would not meet the requirements of the protocol
18 Years
ALL
No
Sponsors
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Biobank
INDUSTRY
Responsible Party
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Principal Investigators
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Jean-Charles LE HUEC, M.D., Prof
Role: PRINCIPAL_INVESTIGATOR
Polyclinique Bordeaux Nord Aquitaine - BORDEAUX - FRANCE
Locations
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Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ID-RCB : 2019-A02979-48
Identifier Type: -
Identifier Source: org_study_id