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Bone Graft

Infuse™ Bone Graft for Spinal Fusion (TLIF Trial)

N/A
Recruiting
Research Sponsored by Medtronic Spinal and Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has preoperative back and leg pain scores of (back pain ≥ 1 and leg pain ≥ 4) based on the Preoperative Back and Leg Pain Questionnaire.
History of radiating leg or buttock pain, paresthesia, numbness or weakness, or History of neurogenic claudication.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

TLIF Trial Summary

This trial will compare the safety and effectiveness of Infuse™ Bone Graft to iliac crest autograft (ICA) in subjects undergoing a TLIF procedure.

Who is the study for?
This trial is for adults with degenerative spine disease causing back pain, leg or buttock pain, numbness, or weakness. They must have tried non-surgical treatments for six months without success and have certain levels of disability and pain. Excluded are those with previous major spine surgeries, severe osteoporosis, morbid obesity, active cancer, infections, metabolic disorders affecting bone growth, allergies to study materials, mental incompetence, substance abuse issues or other conditions that might affect results.Check my eligibility
What is being tested?
The trial tests the safety and effectiveness of Infuse™ Bone Graft in spinal fusion surgery (TLIF) on patients with lumbosacral spine disease. It's a global study where participants will be randomly assigned to receive either the new treatment or a control intervention and monitored over 24 months postoperatively.See study design
What are the potential side effects?
Potential side effects may include reactions at the graft site such as inflammation or infection; allergic reactions to materials used; complications related to bone growth like abnormal fusion; general surgical risks like bleeding and nerve damage; plus any specific adverse events associated with Infuse™ Bone Graft.

TLIF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My back pain score is at least 1 and my leg pain score is 4 or more.
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I have had leg, buttock pain, numbness, or weakness, or I've experienced pain when walking that improves with rest.
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I am 18 or older and my bones have stopped growing.
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I have a confirmed spine condition from scans showing issues like slippage or narrowing.
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I have back pain due to nerve issues in my lower spine affecting my legs or buttocks.
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I am 18 or older and my bones have stopped growing.
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I have back pain due to nerve issues in my lower spine affecting my legs or buttocks.
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My condition didn't improve after 6 months of non-surgical treatments.
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My back pain significantly limits my daily activities.

TLIF 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.
Primary outcome measures
Fusion success at 24 months
Overall success at 24 months
Secondary outcome measures
Back pain success
Leg pain success
Neurological success
+4 more

TLIF Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group #2Experimental Treatment2 Interventions
Investigational Infuse™ 4.2 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Group II: Group #1Experimental Treatment2 Interventions
Investigational Infuse™ 2.1 mg/level with available local bone autograft and supplemented with cancellous allograft as needed
Group III: ControlActive Control1 Intervention
Local bone autograft and supplemented with cancellous allograft as needed.

Find a Location

Who is running the clinical trial?

Medtronic Spinal and BiologicsLead Sponsor
55 Previous Clinical Trials
9,571 Total Patients Enrolled

Media Library

Degenerative Lumbosacral Spine Disease Research Study Groups: Group #1, Control, Group #2
TLIF (Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04073563 — N/A
Degenerative Lumbosacral Spine Disease Patient Testimony for trial: Trial Name: NCT04073563 — N/A

Frequently Asked Questions

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

How many participants are being recruited to this research endeavor?

"Affirmative, according to the clinicaltrials.gov listing this trial is in need of participants. The initial post date was December 19th 2019 and it has been revised on November 30th 2022. 1017 individuals should be enrolled from 35 different sites for completion of the study."

Answered by AI

How many sites are providing participants with access to this experimental trial?

"35 clinical trial sites are taking part in this research project, including the University of California Davis Medical Center (Sacramento), Montefiore Medical Center (Bronx) and Saint Thomas for Specialty Surgery (Nashville). Other participating locations can be found on our website."

Answered by AI

Could you explain the objectives of this trial?

"The primary objective of this clinical trial, which will be monitored over a two-year span is to ascertain the success rate with regards to fusion. Secondary outcomes include determining how much back and leg pain has been ameliorated; an NRS score of 0 indicating no discomfort while 10 representing maximum distress must have decreased by at least 20% from preoperative readings. Furthermore, any Serious Adverse Events connected to TLIF grafting material or interbody device within 24 months are also being evaluated."

Answered by AI

Are there any remaining openings for participants in this research?

"According to the data published on clinicaltrials.gov, this study is presently in search of participants. It was uploaded onto the website on December 19th 2019 and last modified November 30th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Northwestern Medicine
William Beaumont Hospital
American Neurospine Institute
Other
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Tired of the lower back pain. Drugs and the injections don’t help anymore.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Transforaminal Lumbar Interbody Fusion (TLIF)
2019. "Transforaminal Lumbar Interbody Fusion (TLIF)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04073563.
~312 spots leftby Apr 2026
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