Allogeinic Bone Paste
NCT04605120 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2020-10-27
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.
Conditions
- Cervical Fusion
- Cervical Disc Degeneration
- Spinal Fusion
Interventions
- PROCEDURE
-
Cervical fusion
1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft
Sponsors & Collaborators
-
Biobank
lead INDUSTRY
Principal Investigators
-
Jean-Charles LE HUEC, M.D., Prof · Polyclinique Bordeaux Nord Aquitaine - BORDEAUX - FRANCE
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-15
- Primary Completion
- 2023-06-30
- Completion
- 2023-09-30
Countries
- France
Study Locations
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