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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeinic Bone Paste | Experimental | Supercritical CO2 viral-inactivated allogeinic bone paste derived from human living donor femoral heads |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical fusion | Procedure | 1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall subject study success |
Overall subject study success is defined as (1) no device or implantation procedure related SAEs; (2) no additional surgical intervention at the operative level, including supplemental fixation, revision, and/or device removal; and (3) minimum 15-point improvement in NDI scores. | 3, 6,12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain and Self reported outcomes |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gregoire EDORH, PhD | Contact | +33164420075 | gedorh@biobank.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jean-Charles LE HUEC, M.D., Prof | Polyclinique Bordeaux Nord Aquitaine - BORDEAUX - FRANCE | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinique Bordeaux Nord Aquitaine | Recruiting | Bordeaux | 33000 | France |
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| ID | Term |
|---|---|
| D007714 | Klippel-Feil Syndrome |
| ID | Term |
|---|---|
| D004413 | Dysostoses |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Non-randomized, Single centre
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| 3, 6, 12 and 24 months |
| D009139 |
| Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |