Spinal FusionNCT04629794
The OsteoStrand Plus Deformity Study
A study testing Posterolateral Lumbar Fusion with Demineralized Bone Fibers and Posterolateral Lumbar Fusion with Bone Morphogenic Protein in people with Spinal Fusion, run by SeaSpine, Inc. at 1 site in United States.
Trial summary
A clinical study evaluating outcomes for patients with spinal deformity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- Posterolateral Lumbar Fusion with Demineralized Bone Fibers and Posterolateral Lumbar Fusion with Bone Morphogenic Protein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2020to 30 Jun 2024
- 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
- Indicated for deformity correction surgery
- Require spinal fusion at four or more levels
- Are willing to return for follow-up visits
- Willing to sign the Informed Consent Forms
Who cannot join
- Uncontrolled diabetes
- Morbid obesity
- history of alcohol or drug abuse
- Corticosteroid use
- Fever or leukocytosis
- Systemic infection
Show all 20Show fewer
- Active malignancy
- Elevation of white blood cell count
- Osteoporosis
- Disease of bone metabolism
- Unsuitable or insufficient bone support
- Skeletal immaturity
- Prior fusion
- Use of steroids, immune suppressants, osteoporosis medications
- Use of internal bone stimulators
- Institutionalized or a prisoner
- Undergoing (Undergone) a worker's compensation case
- Pregnancy (includes women who are currently pregnant, lactating or wishing to become pregnant during the study duration)
- Participation in another research study involving another implant, product or drug that may affect the outcomes of this clinical study within the last 30 days, or planned during 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
A clinical study evaluating outcomes for patients with spinal deformity.
Read the detailed description
A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.
- Conditions
- Spinal Fusion
- Being tested
- Posterolateral Lumbar Fusion with Demineralized Bone Fibers, Posterolateral Lumbar Fusion with Bone Morphogenic Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterolateral Lumbar Fusion with Demineralized Bone FibersProcedure or surgery
Posterolateral Lumbar Fusion with Demimeralized Bone Fibers
Posterolateral Lumbar Fusion with Bone Morphogenic ProteinProcedure or surgery
Posterolateral Lumbar Fusion with Bone Morphogenic Protein
| Study group | Role | What they receive |
|---|---|---|
| Demineralized Bone Matrix | Active comparator | Prospective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM). Receives: Procedure: Posterolateral Lumbar Fusion with Demineralized Bone Fibers |
| Bone Morphogenic Protein | Active comparator | Retrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP). Receives: Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic Protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion.
Measured: 12 Months
Secondary outcomes (1)
Clinical outcomes
Oswestry Disability Index (ODI)
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 start5 Mar 2020
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- SeaSpine, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Chang, MD, Principal investigator, Sonoran Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629794
- Sponsor's protocol ID
- SS-OS-1802
- 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
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 OsteoStrand Plus Deformity Study
- ClinicalTrials.gov ID
- NCT04629794
- Acronym / sponsor ID
- SS-OS-1802
- Conditions
- Spinal Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (actual)
- Lead sponsor
- SeaSpine, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (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 outcomes for patients with spinal deformity.
Detailed description
A clinical study evaluating deformity patients treated with Demineralized Bone Matrix as compared to patients treated with Bone Morphogenetic Protein.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Demineralized Bone Matrix | Active comparator | Procedure: Posterolateral Lumbar Fusion with Demineralized Bone FibersProspective cohort subjects undergoing deformity correction surgery that receive Demineralized Bone Matrix (DBM). |
| Bone Morphogenic Protein | Active comparator | Procedure: Posterolateral Lumbar Fusion with Bone Morphogenic ProteinRetrospective cohort subjects that underwent deformity correction surgery and received Bone Morphogenic Protein (BMP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- -≥18 years of age
- Indicated for deformity correction surgery
- Require spinal fusion at four or more levels
- Are willing to return for follow-up visits
- Willing to sign the Informed Consent Forms
Key exclusion criteria (20 listed)
- Uncontrolled diabetes
- Morbid obesity
- history of alcohol or drug abuse
- Corticosteroid use
- Fever or leukocytosis
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 |
|---|---|---|
| Posterolateral Lumbar Fusion with Demineralized Bone FibersPosterolateral Lumbar Fusion with Demimeralized Bone Fibers | Procedure or surgery | Demineralized Bone Matrix |
| Posterolateral Lumbar Fusion with Bone Morphogenic ProteinPosterolateral Lumbar Fusion with Bone Morphogenic Protein | Procedure or surgery | Bone Morphogenic Protein |
Primary outcome
Assessment of fusion for the demineralized bone matrix cohort vs bone morphogenic protein cohort
Time frame: 12 Months
Proportion of spinal levels in the demineralized bone matrix cohort vs bone morphogenic protein cohort achieving fusion.
1 secondary outcome
Clinical outcomes
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.
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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.
Michael Chang, MD principal investigator
Sonoran Spine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterolateral Lumbar Fusion with Demineralized Bone Fibers and Posterolateral Lumbar Fusion with Bone Morphogenic Protein in people with Spinal 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 5 inclusion and 20 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 demineralized bone matrix cohort vs bone morphogenic protein cohort (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.