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Bone Graft

P-15L Bone Graft for Degenerative Disc Disease

N/A
Waitlist Available
Research Sponsored by CeraPedics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Skeletally mature adults between 22 and 80 years old (inclusive)
Back pain with radicular symptoms as evidenced by leg pain, confirmed by history and physical exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing whether an investigational device is not worse than a control device in terms of effectiveness and safety for a type of back surgery. A sub-group analysis will be performed on people who are considered high-risk for complications from the surgery.

Who is the study for?
Adults aged 22-80 with degenerative disc disease causing back and leg pain, who have not had previous spinal fusion at the affected level (between L2 and S1) can join. They must score ≥35 on a specific back pain questionnaire. Those with significant metabolic diseases affecting bone growth, active cancer, or needing multiple-level fusions are excluded.Check my eligibility
What is being tested?
The trial is testing if P-15L Bone Graft is as effective and safe as local autologous bone for use in spinal fusion surgery (TLIF) with instrumentation in patients with degenerative disc disease. It will also look closely at results in high-risk groups like smokers, obese individuals, and diabetics.See study design
What are the potential side effects?
Potential side effects may include typical surgical risks such as infection, bleeding, nerve damage or persistent pain at the graft site. Specific to P-15L Bone Graft could be reactions related to bone growth or integration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 22 and 80 years old.
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I have back pain that spreads to my legs, confirmed by a doctor.
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My affected spinal discs are between L2 and S1.

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
Neurological deficit
No serious device-related adverse event
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: P-15L Bone GraftExperimental Treatment1 Intervention
The investigational group will be treated with P-15L Bone Graft in an instrumented TLIF
Group II: Local autologous boneActive Control1 Intervention
The active control group will be treated with local autologous bone in an instrumented TLIF

Find a Location

Who is running the clinical trial?

CeraPedics, IncLead Sponsor
5 Previous Clinical Trials
1,069 Total Patients Enrolled

Media Library

P-15L Bone Graft (Bone Graft) Clinical Trial Eligibility Overview. Trial Name: NCT03438747 — N/A
Degenerative Disc Disease Research Study Groups: P-15L Bone Graft, Local autologous bone
Degenerative Disc Disease Clinical Trial 2023: P-15L Bone Graft Highlights & Side Effects. Trial Name: NCT03438747 — N/A
P-15L Bone Graft (Bone Graft) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03438747 — N/A
Degenerative Disc Disease Patient Testimony for trial: Trial Name: NCT03438747 — N/A

Frequently Asked Questions

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

What are the eligibility requirements for participating in this research project?

"This medical trial is enrolling 290 individuals aged 22 to 80 who are suffering from intervertebral disc degeneration. To be eligible, patients must receive a score of at least 35 on the Oswestry Low Back pain Disability Questionnaire and display back pain with radicular symptoms evident through leg pain. The affected vertebrae should fall between L2 and S1, indicating skeletally mature adults only."

Answered by AI

Is the trial open to those who are 35 years old or younger?

"The age range for enrollees in this trial is between 22-80 years old. Other studies are available to minors and elderly patients, comprising two trials for those below the age of 18 and fifty-eight above 65."

Answered by AI

Are there multiple healthcare centers in Canada conducting this research endeavor?

"The trial is currently active in 35 different sites, such as Tampa, Charlottesville and West Hollywood. To limit the amount of travel necessary for participation it may be beneficial to select a study centre close by."

Answered by AI

Are they still accepting participants for this clinical investigation?

"According to the clinicaltrials.gov listings, this medical trial is not currently recruiting patients anymore; its initial posting was on April 24th 2018 and it has since been updated lastly on February 18th 2022. However, there are presently 62 other similar trials that require new participants."

Answered by AI

Who else is applying?

What state do they live in?
California
Indiana
Other
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
The University of Alabama at Birmingham
Center for Spine and Orthopedics
Northwestern University
Other

Why did patients apply to this trial?

I need relief. I am in a lot of pain and would love to be out of pain. Recently hurt my back at work. Getting the burning feeling again.
PatientReceived 2+ prior treatments
I experience this pain and nothing has worked to help ease the pain. I'm seeking something that will help relieve my back pain & sciatica.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
2018. "P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03438747.
All > Degenerative Disc Disease
~41 spots leftby Apr 2025
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