New spinal implant shows promise in back surgery study
NCT ID NCT05566704
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how safe and well a new spinal implant (Modulus ALIF System) works in 123 adults having back surgery. The patients had conditions like worn-out discs or slipped vertebrae. The main goals were to check for complications and see if the bones fused properly after at least 6 months.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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123 people
The number who actually took part.
- Started
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Aug 2022
- Finished
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May 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The analysis population will include all subjects who meet the criteria for enrollment, specifically, those subjects who: * Satisfied the inclusion and exclusion criteria * Previously underwent the surgical procedure as defined in this protocol
- Ages
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18 years and older
- Sex
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Anyone
Show the full entry requirements Hide 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: 1. Availability of progress notes and radiographic information preoperatively and a minimum of 6 months following surgery 2. Male or female patients who are ≥18 years of age at the time of surgery 3. Had undergone a regiment of at least six (6) months of nonoperative care treatment prior to being treated with the Modulus ALIF system, except in patients with progressive neurological deficits, neurogenic claudication causing significant disability, or developed cauda equine syndrome 4. Treated with ALIF procedure with the Modulus ALIF System at: * One or two adjacent lumbar and/or lumbosacral levels for degenerative disc disease (DDD), degenerative spondylolisthesis, or spinal stenosis, or * Any number of lumbar and/or lumbosacral levels for degenerative scoliosis (defined as \>10º coronal curve) or sagittal deformity 5. Supplemental fixation cleared by the applicable regulatory body for use in the thoracolumbar spine unless the procedure meets all of the following criteria: * 1-2 levels treated for DDD, and * 3 or 4 interfixated screws placed, and * Implant lordosis is ≤20° Exclusion Criteria: 1. Patient was a prisoner at the time of Modulus ALIF treatment 2. Patient was participating in another clinical study during treatment that would confound study data
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Atlantic Brain and Spine
Wilmington, North Carolina, 28401, United States
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Georgia Spine & Neurosurgery Center
Atlanta, Georgia, 30342, United States
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Girard Orthopedic Surgeons
San Diego, California, 92121, United States
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Hoag Orthopedics
Orange, California, 92868, United States
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OrthoCarolina
Charlotte, North Carolina, 28207, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can keyhole spine fusion ease chronic back pain?
- Can ultrasound dye reveal spinal cord damage Mid-Surgery?
- A conversation before spine surgery could change how patients recover
- Can a new bone graft match the gold standard for spinal fusion?
- Can a nanotube surface help spinal bones fuse faster?
- Can a growth factor from donor bone improve spinal fusion?