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New putty may help back surgery patients heal faster

NCT ID NCT07199075

Disease control Sponsor: AO Innovation Translation Center Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at a special putty called Fibergraft used in spine surgery to help bones grow together. About 80 adults with back pain or nerve problems from spine issues will get this putty during surgery. Doctors will check how well the bones heal using CT scans and ask patients about their recovery. The goal is to see if this material works well without needing extra bone from elsewhere.

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 80 people

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

Expected to start

Oct 2025

An estimate. Start dates often move.

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 with spinal degenerative deseases from the St Mateenskliniek

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: * Adults ≥ 18 years old * Diagnosed with the following lumbar spine disorders: foraminal nerve root compression, isthmic spondylolisthesis, and short-segment (1-2 levels) deformity. * Undergone primary surgery of ALIF or XLIF using titanium cages filled with standalone Fibergraft and with the following criteria fulfilled (ie, the index surgery): * ALIF (up to 2 levels) as either standalone (ie, no posterior procedure) or as an anterior first procedure with posterior procedure as a second procedure. * XLIF (up to 2 levels) as an anterior first procedure with posterior procedure as a second procedure. * Consenting to have CT scans taken to allow assessment of fusion status at 12-24 months post index surgery * This criterion is applicable to patients who have not undergone revision surgery. * For patients who have undergone revision surgery due to any reason other than nonunion, which typically occurs within 1 year of the index surgery, this criterion is only applicable if it is possible to obtain the CT scan within 12-24 months of the index surgery. If no CT scan can be taken during this window, the patient does not need to undergo the CT scan; in such cases, the CT scan that has been taken as part of the standard of care before the revision surgery will be retrospectively retrieved to assess the fusion status at the time of the revision surgery. * This criterion is not applicable to patients who underwent revision surgery due to nonunion, which typically occurs 1 year after the index surgery; these patients do not need to undergo the CT scan. In such cases, the CT scan that has been taken as part of the standard of care before the revision surgery will also be retrospectively retrieved to assess and grade the fusion status at the time of the revision surgery. * Ability to provide informed consent according to the IRB/EC defined and approved procedures Exclusion Criteria: * Revision surgery * Standalone XLIF * Posterior lumbar interbody fusion * Diagnosis of fractures, malignancies, ankylosing spondylitis, or acute cauda equina syndrome * Diagnosis of Parkinson's disease * Body mass index \> 35kg/m2

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Conditions

The condition(s) this trial relates to.

intervertebral disk degenerative disorder radiculopathy spondylolisthesis spondylosis vertebral column disorder vertebral disorder

As listed by the trial registrant

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

Nerve root compress;lumbosac Spine degeneration Spine disorder Spine fusion Spine fusion for degenerative spine disease Spine pain Spondylolisthesis

How to take part

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

  1. The places running it

    1 site. 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

  • St Mateenskliniek

    Ubbergen, 6574, Netherlands

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