Allogeinic Bone Paste

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Primary Purpose

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Cervical fusion

About this trial

This is an interventional treatment trial for Cervical Fusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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

Sites / Locations

Polyclinique Bordeaux Nord AquitaineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Allogeinic Bone Paste

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain and Self reported outcomes

Change from baseline neck and arm pain measured by Visual Analogue Scale (VAS): Patients will be evaluated preoperatively, at 3 months, 6 months, 12 and 24 months Change from baseline Health Survey measured by SF-12: Patients will be evaluated preoperatively, at 3 months, 6 months, 12 and 24 months Potential product benefits assessment by: Surgery time (from incision to wound closure) Product ease of use measured by Visual Analogue Scale (VAS) at immediate postoperative visit.

Full Information

NCT ID

NCT04605120

First Posted

October 22, 2020

Last Updated

October 22, 2020

Sponsor

Biobank

1. Study Identification

Unique Protocol Identification Number

NCT04605120

Brief Title

Allogeinic Bone Paste

Official Title

Prospective, Non-randomized, Single Center Clinical Study of Cervical Interbody Fusion Using a Viral-inactivated Allogeneic Graft

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 15, 2020 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biobank

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Non-randomized, Single centre

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Allogeinic Bone Paste

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Cervical fusion

Intervention Description

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

Primary Outcome Measure Information:

Title

Overall subject study success

Description

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.

Time Frame

3, 6,12 and 24 months

Secondary Outcome Measure Information:

Title

Pain and Self reported outcomes

Description

Change from baseline neck and arm pain measured by Visual Analogue Scale (VAS): Patients will be evaluated preoperatively, at 3 months, 6 months, 12 and 24 months Change from baseline Health Survey measured by SF-12: Patients will be evaluated preoperatively, at 3 months, 6 months, 12 and 24 months Potential product benefits assessment by: Surgery time (from incision to wound closure) Product ease of use measured by Visual Analogue Scale (VAS) at immediate postoperative visit.

Time Frame

3, 6, 12 and 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gregoire EDORH, PhD

Phone

+33164420075

Email

gedorh@biobank.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jean-Charles LE HUEC, M.D., Prof

Organizational Affiliation

Polyclinique Bordeaux Nord Aquitaine - BORDEAUX - FRANCE

Official's Role

Principal Investigator

Facility Information:

Facility Name

Polyclinique Bordeaux Nord Aquitaine

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Charles LE HUEC, M.D; Prof

Phone

+33564601547

Email

jclehuec1@aol.com

12. IPD Sharing Statement

Plan to Share IPD

No

Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial