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Bone Graft Substitute

OSTEOAMP vs. Infuse for Degenerative Disc Disease (SELECT Trial)

N/A
Recruiting
Research Sponsored by Bioventus LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 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)
Must not have
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)
Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin is allowed)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the effectiveness and safety of OSTEOAMP SELECT Fibers to Infuse Bone Graft to a control group when used as a bone graft substitute in skeletally mature patients undergoing lumbar interbody fusion surgery.

Who is the study for?
Adults aged 21-80 with degenerative spinal conditions, specifically at two levels between L2 to S1, who haven't improved after 6 months of non-surgical treatments. Candidates must be able to follow the study's procedures and not have uncontrolled diabetes, active cancer, infections, severe allergies to treatment components, or a history of heavy smoking or substance abuse.
What is being tested?
The trial is testing OSTEOAMP SELECT Fibers against Infuse Bone Graft for safety and effectiveness as bone graft substitutes in lumbar interbody fusion surgery. Each patient serves as their own control by receiving both treatments at different affected spine levels.
What are the potential side effects?
Potential side effects may include reactions related to bone grafting materials such as inflammation at the site, infection risk increase due to surgical intervention, allergic responses if sensitive to treatment components like bovine collagen products or BMPs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 80 years old and my bones have stopped growing.
Select...
I have proof of lower back disease, including slight spine misalignment, from scans.
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I need surgery for back pain at two levels between L2 and S1.
Select...
My condition hasn't improved after 6 months of non-surgical treatments.
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I have back pain from disc disease in my lower spine.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not allergic to any study treatment components like BMPs, collagen, or certain metals.
Select...
I have or had cancer, but skin basal cell carcinoma is okay.
Select...
My diabetes is not well-controlled.
Select...
I am allergic to bacitracin, polymyxin B sulfate, or gentamicin.
Select...
My spine curves more than 30 degrees.
Select...
I have a history of bone conditions like osteoporosis or Paget's disease.
Select...
I do not have any current bacterial infections.
Select...
My BMI is over 40.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Fusion Status
Other study objectives
Back Pain
Functional Impairment
Leg Pain

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: InfuseActive Control1 Intervention
The Infuse Bone Graft as an autograft substitute in lumbar interbody fusion procedures
Group II: OSTEOAMPActive Control1 Intervention
OSTEOAMP SELECT Fibers as an autograft substitute in lumbar interbody fusion procedures

Find a Location

Who is running the clinical trial?

Bioventus LLCLead Sponsor
16 Previous Clinical Trials
15,130 Total Patients Enrolled

Media Library

OSTEOAMP (Bone Graft Substitute) Clinical Trial Eligibility Overview. Trial Name: NCT05405374 — N/A
Lumbar Spine Disease Research Study Groups: Infuse, OSTEOAMP
Lumbar Spine Disease Clinical Trial 2023: OSTEOAMP Highlights & Side Effects. Trial Name: NCT05405374 — N/A
OSTEOAMP (Bone Graft Substitute) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405374 — N/A
Lumbar Spine Disease Patient Testimony for trial: Trial Name: NCT05405374 — N/A
~28 spots leftby Dec 2025
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