Allogeinic Bone Paste

NCT04605120 | Unknown

• 1 other identifier: ID-RCB : 2019-A02979-48
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Overall subject study success

  * Change from baseline Neck Disability Index (NDI): Patients will be evaluated preoperatively, at 3 months, 6 months, 12 and 24 months * Rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) and reoperations during Follow-up visits * Interbody fusion rate measured by CT scans and standard radiographs at 3 months, 6 months, 12 and 24 months 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

Secondary Outcomes (1)

• Pain and Self reported outcomes

  3, 6, 12 and 24 months

Study Arms (1)

Allogeinic Bone Paste

EXPERIMENTAL

Supercritical CO2 viral-inactivated allogeinic bone paste derived from human living donor femoral heads

Procedure: Cervical fusion

Interventions

Cervical fusion PROCEDURE

1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft

Allogeinic Bone Paste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biobank: lead

Study Sites (1)

Polyclinique Bordeaux Nord Aquitaine

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Klippel-Feil Syndrome

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jean-Charles LE HUEC, M.D., Prof

  Polyclinique Bordeaux Nord Aquitaine - BORDEAUX - FRANCE

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregoire EDORH, PhD

CONTACT

+33164420075; gedorh@biobank.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non-randomized, Single centre

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 27, 2020
• Study Start: September 15, 2020
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: October 27, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)