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New bone graft could improve spinal fusion outcomes

NCT ID NCT03438747

Disease control Sponsor: CeraPedics, Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new bone graft material (P-15L) for spinal fusion surgery in people with degenerative disc disease. The goal is to see if it works as well as the standard bone graft in helping bones fuse together and reducing pain. About 290 adults aged 22-80 will take part, and the study will also look at how well it works in people who smoke, are obese, or have diabetes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

290 people

The number who actually took part.

Started

Apr 2018

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria (abbreviated): 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; Oswestry Low Back Pain Disability Questionnaire score of ≥ 35; Involved disc(s) between L2 and S1; Exclusion Criteria (abbreviated): Significant metabolic disease that in the surgeon's opinion might compromise bone growth such as osteoporosis, osteopenia, or osteomalacia; Active malignancy; Nondiscogenic source of symptoms (e.g. tumor, etc.); Multiple level symptomatic degenerative disc disease where more than one level requires fusion; Previous spinal instrumentation or a previous interbody fusion procedure at the involved level; More than one level to be fused

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Degenerative disc disease

Contacts and locations

Locations

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212, United States

  • Austin Neurosurgeons

    Austin, Texas, 78746, United States

  • Carle Foundation Hospital

    Urbana, Illinois, 61801, United States

  • Cedars-Sinai

    West Hollywood, California, 90069, United States

  • Center for Spine and Orthopedics

    Thornton, Colorado, 80229, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Florida Orthopaedic Institute

    Tampa, Florida, 33637, United States

  • Glendale Adventist Medical Center

    Glendale, California, 91206, United States

  • Indiana Spine Group

    Carmel, Indiana, 46032, United States

  • Keck School of Medicine USC

    Los Angeles, California, 90033, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Norton Leatherman Spine Center

    Louisville, Kentucky, 40202, United States

  • OrthoIndy

    Indianapolis, Indiana, 46278, United States

  • Orthopaedic Institute of Western Kentucky

    Paducah, Kentucky, 42001, United States

  • Rothman Institute

    Philadelphia, Pennsylvania, 19107, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210, United States

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • Texas Back Institute

    Plano, Texas, 73509, United States

  • The Orthopedic Center at Mount Sinai West

    New York, New York, 10029, United States

  • The University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UC Davis Spine Center

    Sacramento, California, 95816, United States

  • UC Irvine Medical Center

    Orange, California, 92868, United States

  • UConn Health

    Farmington, Connecticut, 06030, United States

  • University Of Buffalo

    Buffalo, New York, 14203, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pittsburgh Medical Canter

    Pittsburgh, Pennsylvania, 15213, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.