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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

SELECT Trial 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.Check my eligibility
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.See study design
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.

SELECT Trial 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.
Select...
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.
Select...
I have back pain from disc disease in my lower spine.

SELECT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Fusion Status
Other outcome measures
Back Pain
Functional Impairment
Leg Pain

SELECT 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
15,147 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment quota for this research project?

"To operate this clinical trial, a total of 101 compliant participants are necessary. Bioventus LLC is responsible for running the study and has selected Austin Neurosurgeons in Austin, Texas and Indiana Spine Group in Carmel, Indiana as two primary locations."

Answered by AI

What are the extant sites for this experiment?

"A total of 8 facilities are participating, such as Austin Neurosurgeons in Austin, Indiana Spine Group in Carmel and OrthoVirginia in Richmond."

Answered by AI

Does this experimental research include participants aged 55 and over?

"Patients who are of legal age and have not exceeded 80 years old can participate in this trial."

Answered by AI

Is this clinical trial currently open to accepting new participants?

"Affirmative, the information on clinicaltrials.gov confirms that this medical study is actively recruiting patients. This trial was first posted on May 6th 2022 and has recently been updated on November 30th of the same year. Subsequently, 101 participants have to be recruited from 8 different sites."

Answered by AI

Are there eligibility requirements to join this medical experiment?

"This medical trial aims to recruit a population of 101 skeletally mature people, aged between 21 and 80, who suffer from intervertebral disc degeneration. The participants must also fulfill the following criteria: have chronic back pain with or without neuralgic components confirmed by physical examination and imaging; show signs of lumbar DDD in radiographs (e.g., CT scan, MRI, X-ray); evidence Grade 1 spondylolisthesis at affected level(s), require fusion surgery for two adjacent or nonadjacent levels from L2 to S1; had no response to conservative treatments such as bed rest,"

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
Kansas
Texas
What site did they apply to?
Orthopaedic Institute of Western Kentucky
Other
Spine Institute of Louisiana
Austin Neurosurgeons
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Tired of being in pain daily. For relief of pain so I can move and be able to live life a little.
PatientReceived 2+ prior treatments
So many Dx and so many treatments... None of which really seem to have helped.
PatientReceived 1 prior treatment
I have tried more than 5 medications and I continue to have pain, even with surgeries, spinal cord stimulator, tens unit, injections and chiropractic care.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

How long does each visit require and does trial pay for travel expenses?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
2022. "OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05405374.
All > Degenerative Disc Disease
~18 spots leftby Oct 2024
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