Rate of Bone Union After Surgery With Stand-alone Fibergraft (NCT07199075) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Rate of Bone Union After Surgery With Stand-alone Fibergraft
Netherlands80 participantsStarted 2025-10-31
Plain-language summary
Some people have back problems caused by degenerative conditions or instability of the spine (eg. Spondylolisthesis). These problems can lead to pain, nerve issues, or difficulties in walking. A common treatment is a type of back surgery called lumbar interbody fusion, which helps stabilize the spine.
At the St. Maartenskliniek in the Netherlands, doctors have been using a special material called Fibergraft Bioactive Glass Putty for such surgeries since 2023. This material helps bones grow and heal, and it's placed inside the spine without needing extra bone from another part of the body.
This study will look at how well this material works by evaluating how many patients' bones successfully healed after surgery using this material. It will also look at how patients feel and recover after the procedure
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Interbody fusion status
Timeframe: 12months to 24th months after index surgery