Lumbar Spine DiseaseSELECTNCT05405374
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
A study testing OSTEOAMP and Infuse in people with Lumbar Spine Disease and Lumbar Spondylolisthesis, run by Bioventus LLC at 9 sites in United States.
Trial summary
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Lumbar Spine Disease, Lumbar Spondylolisthesis, Lumbar Spine Instability
- What is being tested?
- OSTEOAMP and Infuse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 9 sitesUnited States
- Study dates
- 6 May 2022to Oct 2025
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletally mature male or female patient, at least 21 years of age and no more than 80 years of age, inclusive, at the time of surgery;
- Has symptomatic degenerative disc disease (DDD) of the lumbosacral spine in two levels (L2 to S1). Lumbar DDD is defined as discogenic back pain with or without radicular symptoms confirmed by patient history and radiographic studies
- Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including instability up to and including Grade 1 spondylolisthesis at the involved level(s)
- Requires fusion (i.e., symptomatic) at 2 adjacent or non-adjacent levels from L2 to S1;
- Non-responsive to non-operative treatment (e.g., bed rest, physical therapy, medication,spinal injection, manipulation, and/or TENS) for at least 6 months;
- Willing and able to comply with the study protocol (including post-operative clinical and radiographic evaluations and required rehabilitation plan) and able to understand and sign the Informed Consent.
Who cannot join
- Previous lumbar spine surgery with the exception of discectomy and/or laminectomy at the target levels.
- Lumbar scoliosis >30 degrees.
- Documented history of osteoporosis, osteomalacia, Paget's disease or metabolic bone disease
- Morbidly obese, as defined by a Body Mass Index (BMI) >40 kg/m2.
- Documented history of uncontrolled diabetes mellitus
- Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin is allowed).
Show all 19Show fewer
- Overt or active bacterial infection, either local to surgical space or systemic.
- Chronic use of steroids (defined as more than 6 weeks of steroid use within 12 months of surgery, other than episodic use or inhaled corticosteroids)
- Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.
- Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid arthritis, Graves' disease, Hashimoto's thyroiditis).
- Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers- Danlos syndrome, or osteogenesis imperfecta).
- History of hypersensitivity and/or allergy to any of the agents used to process OSTEOAMP SELECT, including bacitracin, polymyxin B sulfate, and gentamicin.
- Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen; protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy, cobalt chrome,cobalt chrome alloy, or PEEK).
- Is a prisoner.
- Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.
- Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for the duration of the study.
- A history of alcohol and/or drug abuse within 6 months prior to screening or exhibits evidence, in the investigator's opinion, of alcohol/drug abuse at screening.
- Current history of heavy nicotine use (e.g. more than 20 cigarettes per day).
- Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data interpretation.
Trial locations and contacts
9 sites in 1 country.
Adam Waksman, DVM contact
9 sites in 1 country
United States9 sites, 8 recruiting
- Recruiting
Austin Neurosurgeons
Austin, Texas, 78746
Kelly Van Schouwen, MS, ACRP-CP, 737-249-0275, kelly@researchtex.com
Daniel Peterson, MD
- Recruiting
New England Baptist Hospital
Boston, Massachusetts, 02120
Lauren Schoeller, 617-754-6609, lschoell@nebh.org
Ruijia Niu, 617-754-6609, rniu@nebh.org
- Recruiting
West Virginia University
Morgantown, West Virginia, 26506
Jennifer Eicher, 304-293-1074, jeicher@hsc.wvu.edu
Scott Daffner, MD
- Recruiting
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37209
Erika Frazier, FrazierEE@TOA.COM
Ryan Snowden, MD
- Recruiting
Yale University
New Haven, Connecticut, 06510
Edgar Benitez, edgar.benitez@yale.edu
Daniel Rubio, MD
- Recruiting
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
Rebekah Vinson, 270-442-9461 ext. 2142, rvinson@oiwky.com
K. Brandon Strenge, MD
- Recruiting
OrthoVirginia
Richmond, Virginia, 23235
Erin Brown, LPN, 804-806-3903, Erin.Brown@orthovirginia.com
Joshua Herzog, MD
- Active, not recruiting
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
- Recruiting
Kansas Joint and Spine Specialists
Wichita, Kansas, 67226
Collin Nevil, MD, cnevil2@kumc.edu
Jaden Hutfles, NP, jhutfles@ksjointspine.com
About this study
Official title: A Prospective, Randomized, Intra-Patient Controlled, Multi-Center Clinical Investigation Evaluating OSTEOAMP SELECT Fibers Versus Infuse Bone Graft as Autograft Substitute in Lumbar Fusion Procedures
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.
Read the detailed description
The current study will collect clinical evidence for OSTEOAMP SELECT in spinal fusion procedures. In particular, the study will explore the use of OSTEOAMP SELECT as part of a lumbar interbody fusion (LIF) procedure of two lumbar motion segments between L2 to S1 in patients suffering from symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or mild degenerative scoliosis.
Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months.
Safety will be evaluated by documenting the number and nature of all (serious) adverse events that may in any way be related to the surgical procedure or product. The complication rate will be compared to the rate in control populations from literature.
- Conditions
- Lumbar Spine Disease, Lumbar Spondylolisthesis, Lumbar Spine Instability, Lumbar Spondylosis, Degenerative Disc Disease
- Being tested
- OSTEOAMP, Infuse
- Keywords
- Lumbar Interbody Fusion
- Medical subject headings
- Spinal Diseases, Spondylolisthesis, Spondylosis, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OSTEOAMPOther
OSTEOAMP SELECT Fibers (derived from human bone allograft) rehydrated with bone marrow aspirate (BMA) and combined with local autogenous graft for use in lumbar interbody fusion of the lumbar spine.
InfuseDevice
The Infuse Bone Graft/Medtronic Interbody Fusion Device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). rhBMP-2 is the active agent in the Infuse Bone Graft component. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2.
| Study group | Role | What they receive |
|---|---|---|
| OSTEOAMP | Active comparator | OSTEOAMP SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures Receives: Other: OSTEOAMP |
| Infuse | Active comparator | The Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures Receives: Device: Infuse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fusion Status
Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.
Measured: 12 Months
Secondary outcomes (1)
Fusion Status
Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.
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 posted6 Jun 2022
- Study start6 May 2022
- Primary completionOct 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spine DiseaseStudies 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
- Model description
- In this study, all subjects will be treated at 2 levels of the anterior lumbar spine. One of the levels will be grafted with OSTEOAMP SELECT and the other with Infuse housed within the same type of interbody cage. The assignment of the bone graft product to each treated motion segment will be randomized in a 1:1 ratio. Every subject will serve as his/her own control.
- Masking
- None (open label)
- Enrolment
- 101 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioventus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405374
- Sponsor's protocol ID
- BGS-21-01
- Acronym
- SELECT
- Status last verified
- Aug 2023
- First submitted
- 9 Dec 2021
- Last updated
- 28 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Intra-Patient Controlled, Multi-Center Clinical Investigation Evaluating OSTEOAMP SELECT Fibers Versus Infuse Bone Graft as Autograft Substitute in Lumbar Fusion Procedures
- ClinicalTrials.gov ID
- NCT05405374
- Acronym / sponsor ID
- SELECT / BGS-21-01
- Conditions
- Lumbar Spine Disease, Lumbar Spondylolisthesis, Lumbar Spine Instability, Lumbar Spondylosis, Degenerative Disc Disease
- Keywords
- Lumbar Interbody Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 101 participants (estimated)
- Lead sponsor
- Bioventus LLCIndustry (pharma, biotech, devices)
- Study start
- 6 May 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 Jun 2022 (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.
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.
Detailed description
The current study will collect clinical evidence for OSTEOAMP SELECT in spinal fusion procedures. In particular, the study will explore the use of OSTEOAMP SELECT as part of a lumbar interbody fusion (LIF) procedure of two lumbar motion segments between L2 to S1 in patients suffering from symptomatic degenerative disc disease (DDD), degenerative spondylolisthesis, and/or mild degenerative scoliosis.
Effectiveness will be based on the lumbar interbody fusion rate at the index levels assessed by a treatment-blinded independent reviewer at 12 months and 24 months.
Safety will be evaluated by documenting the number and nature of all (serious) adverse events that may in any way be related to the surgical procedure or product. The complication rate will be compared to the rate in control populations from literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this study, all subjects will be treated at 2 levels of the anterior lumbar spine. One of the levels will be grafted with OSTEOAMP SELECT and the other with Infuse housed within the same type of interbody cage. The assignment of the bone graft product to each treated motion segment will be randomized in a 1:1 ratio. Every subject will serve as his/her own control.
| Arm | Type | Receives |
|---|---|---|
| OSTEOAMP | Active comparator | Other: OSTEOAMPOSTEOAMP SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures |
| Infuse | Active comparator | Device: InfuseThe Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Skeletally mature male or female patient, at least 21 years of age and no more than 80 years of age, inclusive, at the time of surgery;
- Has symptomatic degenerative disc disease (DDD) of the lumbosacral spine in two levels (L2 to S1). Lumbar DDD is defined as discogenic back pain with or without radicular symptoms confirmed by patient history and radiographic studies
- Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including instability up to and including Grade 1 spondylolisthesis at the involved level(s)
- Requires fusion (i.e., symptomatic) at 2 adjacent or non-adjacent levels from L2 to S1;
- Non-responsive to non-operative treatment (e.g., bed rest, physical therapy, medication,spinal injection, manipulation, and/or TENS) for at least 6 months;
Key exclusion criteria (19 listed)
- Previous lumbar spine surgery with the exception of discectomy and/or laminectomy at the target levels.
- Lumbar scoliosis >30 degrees.
- Documented history of osteoporosis, osteomalacia, Paget's disease or metabolic bone disease
- Morbidly obese, as defined by a Body Mass Index (BMI) >40 kg/m2.
- Documented history of uncontrolled diabetes mellitus
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 |
|---|---|---|
| OSTEOAMPOSTEOAMP SELECT Fibers (derived from human bone allograft) rehydrated with bone marrow aspirate (BMA) and combined with local autogenous graft for use in lumbar interbody fusion of the lumbar spine. | Other | OSTEOAMP |
| InfuseThe Infuse Bone Graft/Medtronic Interbody Fusion Device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2, known as dibotermin alfa) placed on an absorbable collagen sponge (ACS). rhBMP-2 is the active agent in the Infuse Bone Graft component. The ACS is a soft, white, pliable, absorbent implantable matrix for rhBMP-2. | Device | Infuse |
Primary outcome
Fusion Status
Time frame: 12 Months
Radiographic fusion as defined by the Image Review Charter and assessed by an independent core laboratory.
1 secondary outcome
Fusion Status
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 28 Aug 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.
Adam Waksman, DVM contact
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OSTEOAMP and Infuse in people with Lumbar Spine Disease and Lumbar Spondylolisthesis, run by Bioventus LLC at 9 sites 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 6 inclusion and 19 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 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Contact Amanda Doan ((901) 341-2976, amanda.doan@bioventus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fusion Status (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 28 Aug 2023; AzTrials last refreshed its copy on 4 Nov 2026.