Status:
NOT_YET_RECRUITING
Rate of Bone Union After Surgery With Stand-alone Fibergraft
Lead Sponsor:
AO Innovation Translation Center
Conditions:
Spine Degeneration
Spine Disorder
Eligibility:
All Genders
18+ years
Brief 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 commo...
Detailed Description
Lumbar interbody fusion is an established procedure for patients with lumbar degenerative conditions and spondylolisthesis, with symptoms of pain, radiculopathy, and/or myelopathy. Completion of fusio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07199075
Start Date
October 31 2025
End Date
May 30 2026
Last Update
September 30 2025
Active Locations (1)
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1
St Mateenskliniek
Ubbergen, Netherlands, 6574