Cervical FusionNCT04605120
Allogeinic Bone Paste
A study testing Cervical fusion in people with Cervical Fusion and Cervical Disc Degeneration, run by Biobank at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion
- What is being tested?
- Cervical fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33000
Jean-Charles LE HUEC, M.D; Prof, +33564601547, jclehuec1@aol.com
About this study
Official title: Prospective, Non-randomized, Single Center Clinical Study of Cervical Interbody Fusion Using a Viral-inactivated Allogeneic Graft
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.
Read the 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.
- Conditions
- Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion
- Being tested
- Cervical fusion
- Medical subject headings
- Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical fusionProcedure or surgery
1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft
| Study group | Role | What they receive |
|---|---|---|
| Allogeinic Bone Paste | Experimental | Supercritical CO2 viral-inactivated allogeinic bone paste derived from human living donor femoral heads Receives: Procedure: Cervical fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3, 6,12 and 24 months
Secondary outcomes (1)
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.
Measured: 3, 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start15 Sep 2020
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non-randomized, Single centre
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biobank
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Charles LE HUEC, M.D., Prof, Principal investigator, Polyclinique Bordeaux Nord Aquitaine - BORDEAUX - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605120
- Sponsor's protocol ID
- ID-RCB : 2019-A02979-48
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-randomized, Single Center Clinical Study of Cervical Interbody Fusion Using a Viral-inactivated Allogeneic Graft
- ClinicalTrials.gov ID
- NCT04605120
- Acronym / sponsor ID
- ID-RCB : 2019-A02979-48
- Conditions
- Cervical Fusion, Cervical Disc Degeneration, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- BiobankIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non-randomized, Single centre
| Arm | Type | Receives |
|---|---|---|
| Allogeinic Bone Paste | Experimental | Procedure: Cervical fusionSupercritical CO2 viral-inactivated allogeinic bone paste derived from human living donor femoral heads |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervical fusion1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft | Procedure or surgery | Allogeinic Bone Paste |
Primary outcome
Overall subject study success
Time frame: 3, 6,12 and 24 months
* 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.
1 secondary outcome
Pain and Self reported outcomes
Time frame: 3, 6, 12 and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Charles LE HUEC, M.D., Prof principal investigator
Polyclinique Bordeaux Nord Aquitaine - BORDEAUX - FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervical fusion in people with Cervical Fusion and Cervical Disc Degeneration, run by Biobank at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gregoire EDORH, PhD (+33164420075, gedorh@biobank.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall subject study success (time frame: 3, 6,12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020; AzTrials last refreshed its copy on 27 Oct 2026.