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Moldable bone putty could improve spine surgery outcomes

NCT ID NCT04775537

Disease control Sponsor: Collagen Matrix 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a moldable bone graft material called OssiMend Bioactive Moldable in people having lumbar spine fusion surgery for degenerative disc disease. The goal is to see if it helps the bones fuse together successfully and reduces pain and disability. About 120 adults who have not improved with other treatments will be enrolled and followed for 12 months.

What this could mean

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

Active substance
OssiMend Bioactive Moldable (a moldable bone graft material used during spine surgery)
What this could lead to
If successful, this could provide a better option for spinal fusion, potentially improving bone healing and reducing pain for people with degenerative disc disease.
What could go wrong
This is a relatively small study (120 people) and results may not apply to everyone. The device is already used, but this trial is testing it in a specific surgical context, so benefits may be modest or not seen at all.

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 120 people

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

Started

Jan 2021

Expected to finish

Jan 2027

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

Subjects must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months

Ages

18 years and older

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: * Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings: * Instability as defined by \>3mm translation or \>5 degrees angulation * Osteophyte formation of facet joints or vertebral endplates * Decreased disc height, on average by \>2mm, but dependent upon the spinal level * Herniated nucleus pulposus * Facet joint degeneration/changes Exclusion Criteria: 1. Subject is under 18 years of age at the time of consent 2. Subject has had prior lumbar spine fusion surgery at any level 3. Subject is currently undergoing treatment for malignancy or has undergone treatment for malignancy 4. Subject is pregnant or nursing or planning to become pregnant during the two years (24 months) following arthrodesis 5. Subject has an active (local or systemic) infection or is undergoing adjunctive treatment for infection 6. Subjects under workers compensation or active litigation

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder lumbar disk degenerative disorder vertebral column disorder

As listed by the trial registrant

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

Degenerative disc disease Spinal disease

How to take part

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

  1. The places running it

    3 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

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06102, United States

  • McKenzie-willamette Medical Center

    COMPLETED

    Eugene, Oregon, 97401, United States

  • San Diego Neurosurgery

    NOT_YET_RECRUITING

    Encinitas, California, 92024, United States

  • University Orthopaedic Associates, Division of OrthoNJ

    NOT_YET_RECRUITING

    Somerset, New Jersey, 08873, United States

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