Spine FusionNCT04629807
Anterior Gen Plus Study
A study testing Anterior Lumbar Interbody Fusion (ALIF) in people with Spine Fusion, run by SeaSpine, Inc. at 1 site in United States.
Trial summary
A clinical study evaluating patients treated with the Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM) in anterior lumbar interbody fusion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spine Fusion
- What is being tested?
- Anterior Lumbar Interbody Fusion (ALIF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 30 Apr 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
- ≥18 years of age
- Requires anterior lumbar interbody (ALIF) fusion
- Are physically and mentally able and willing to return for the scheduled follow up visits, follow post-operative instructions
- Willing and able to sign study specific Informed Consent Form
Who cannot join
- Signs of acute infection
- Active malignancy and/or current chemotherapy
- Prior fusion at operative or adjacent level
- Institutionalized or a prisoner
- Documented history of alcohol or drug abuse
- Undergoing a worker's compensation case
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- Pregnancy
- Participation in another research study involving another implant or drug that may affect the outcomes of this clinical study
- Any other condition that the Investigator determines is unacceptable for enrollment into this clinical study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Anterior Gen Plus Study
A clinical study evaluating patients treated with the Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM) in anterior lumbar interbody fusion.
Read the detailed description
A prospective, single-center, clinical study evaluating patients undergoing primary, contiguous 2-level ALIF without supplemental fixation treated with Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM).
- Conditions
- Spine Fusion
- Being tested
- Anterior Lumbar Interbody Fusion (ALIF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anterior Lumbar Interbody Fusion (ALIF)Procedure or surgery
Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
| Study group | Role | What they receive |
|---|---|---|
| Demineralized Bone Matrix (DBM) | Active comparator | All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Study Implant (one-level) implanted with Demineralized Bone Matrix (DBM). Receives: Procedure: Anterior Lumbar Interbody Fusion (ALIF) |
| Cellular Bone Matrix (CBM) | Active comparator | All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Control Implant (one-level) implanted with Cellular Bone Matrix (CBM). Receives: Procedure: Anterior Lumbar Interbody Fusion (ALIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of fusion for the DBM versus CBM cohorts
Proportion of levels exhibiting fusion for the DBM cohort versus the CBM cohort
Measured: 12 months
Secondary outcomes (1)
Serious Adverse Events (SAEs)
SAEs at 24 months
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start15 Sep 2020
- Primary completion16 Dec 2022
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaSpine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muwaffak Abdulhak, MD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629807
- Sponsor's protocol ID
- SS-OS-1901
- Status last verified
- Mar 2023
- First submitted
- 5 Nov 2020
- Last updated
- 4 Apr 2023
- 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Anterior Gen Plus Study
- ClinicalTrials.gov ID
- NCT04629807
- Acronym / sponsor ID
- SS-OS-1901
- Conditions
- Spine Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- SeaSpine, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 16 Dec 2022 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 16 Nov 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.
A clinical study evaluating patients treated with the Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM) in anterior lumbar interbody fusion.
Detailed description
A prospective, single-center, clinical study evaluating patients undergoing primary, contiguous 2-level ALIF without supplemental fixation treated with Demineralized Bone Matrix (DBM) as compared to a Cellular Bone Matrix (CBM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Demineralized Bone Matrix (DBM) | Active comparator | Procedure: Anterior Lumbar Interbody Fusion (ALIF)All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Study Implant (one-level) implanted with Demineralized Bone Matrix (DBM). |
| Cellular Bone Matrix (CBM) | Active comparator | Procedure: Anterior Lumbar Interbody Fusion (ALIF)All enrolled subjects will undergo primary, contiguous 2-level ALIF without supplemental fixation. Control Implant (one-level) implanted with Cellular Bone Matrix (CBM). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 years of age
- Requires anterior lumbar interbody (ALIF) fusion
- Are physically and mentally able and willing to return for the scheduled follow up visits, follow post-operative instructions
- Willing and able to sign study specific Informed Consent Form
Key exclusion criteria (9 listed)
- Signs of acute infection
- Active malignancy and/or current chemotherapy
- Prior fusion at operative or adjacent level
- Institutionalized or a prisoner
- Documented history of alcohol or drug abuse
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 |
|---|---|---|
| Anterior Lumbar Interbody Fusion (ALIF)Intra-Operative Anterior Lumbar Interbody Fusion (ALIF) | Procedure or surgery | Cellular Bone Matrix (CBM), Demineralized Bone Matrix (DBM) |
Primary outcome
Assessment of fusion for the DBM versus CBM cohorts
Time frame: 12 months
Proportion of levels exhibiting fusion for the DBM cohort versus the CBM cohort
1 secondary outcome
Serious Adverse Events (SAEs)
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- 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.
Muwaffak Abdulhak, MD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anterior Lumbar Interbody Fusion (ALIF) in people with Spine Fusion, run by SeaSpine, Inc. at 1 site in United States.
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 4 inclusion and 9 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 4 Apr 2023. 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 United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of fusion for the DBM versus CBM cohorts (time frame: 12 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 4 Apr 2023.