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New registry tracks Real-World success of synthetic bone grafts for back surgery

NCT ID NCT05329129

Knowledge-focused Sponsor: OssDsign Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry is following 450 adults undergoing spine fusion surgery who receive an OssDsign bone graft substitute. The goal is to see how well the bones fuse together and how patients' quality of life changes over time. It is an observational study, meaning no new treatment is being tested—just real-world data collected.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OssDsign Catalyst (synthetic calcium phosphate bone graft substitute)
What this could lead to
If successful, this registry could provide real-world evidence on how well these bone grafts work for spine fusion, potentially guiding better surgical choices.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove cause and effect. Results may vary across patients and surgeons.

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.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Apr 2030

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.

Who is studied

Patients diagnosed with as a candidate for spinal fusion surgery

Ages

21 years and older

Sex

Anyone

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.

* The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate. * The patient is ≥21 years old. * The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent * The patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years. Exclusion Criteria: * Patients not meeting all of the inclusion criteria

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder spinal stenosis

As listed by the trial registrant

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

Degenerative disc disease Spinal stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Carle Foundation Hospital, NeuroScience Institute

    COMPLETED

    Urbana, Illinois, 61801, United States

  • Central Connecticut Neurosurgery and Spine

    RECRUITING

    New Britian, Connecticut, 06051, United States

  • Community Health Partners Neuroscience

    RECRUITING

    Fresno, California, 93720, United States

  • Foundation for Orthopaedic Research and Education

    RECRUITING

    Tampa, Florida, 33607, United States

  • Memorial Orthopaedic Surgical Group

    RECRUITING

    Long Beach, California, 90806, United States

  • Minimally Invasive Spine Center of South Florida

    RECRUITING

    Miami, Florida, 33133, United States

  • Northeast Georgia Medical Center

    ACTIVE_NOT_RECRUITING

    Gainesville, Georgia, 30501, United States

  • OrthoBethesda Research Foundation

    ACTIVE_NOT_RECRUITING

    Bethesda, Maryland, 20817, United States

  • Orthopaedic Institute of Western Kentucky

    COMPLETED

    Paducah, Kentucky, 42001, United States

  • Orthopedic Associates of Hartford

    ACTIVE_NOT_RECRUITING

    Hartford, Connecticut, 06102, United States

  • San Diego Neurosurgery

    TERMINATED

    San Diego, California, 92024, United States

  • Texas Spine Consultants

    NOT_YET_RECRUITING

    Addison, Texas, 75001, United States

  • Twin Cities Orthopedics

    ACTIVE_NOT_RECRUITING

    Edina, Minnesota, 55435, United States

  • University Orthopedics Center

    RECRUITING

    State College, Pennsylvania, 16801, United States

  • Yale Center for Clinical Investigation, Yale School of Medicine

    RECRUITING

    New Haven, Connecticut, 06519, United States

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