Rate of Bone Union After Surgery With Stand-alone Fibergraft

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Innovation Translation Center

About this trial

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

Eligibility criteria

Qualifiers

Adults ≥ 18 years old

Diagnosed with the following lumbar spine disorders: foraminal nerve root compression, isthmic spondylolisthesis, and short-segment (1-2 levels) deformity.

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.

Disqualifiers

Revision surgery

Standalone XLIF

Posterior lumbar interbody fusion

Diagnosis of fractures, malignancies, ankylosing spondylitis, or acute cauda equina syndrome

Trial design

Treatments tested in this trial

  • Questionnaires
  • Computer Tomography

Treatment groups

No treatment groups listed