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 range18 Years

SexALL

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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…

What they're measuring

Interbody fusion status

Timeframe: 12months to 24th months after index surgery

Trial details

NCT IDNCT07199075

SponsorAO Innovation Translation Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-30

Contact for this trial

Marco Minoia

+41 (0)79 612 09 67 marco.minoia@aofoundation.org