New spine plate shows promise in fusion surgery study
NCT ID NCT04689880
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new plate system used during spine fusion surgery in 75 adults with conditions like degenerative disc disease or scoliosis. The goal was to see if the plate is safe and helps bones fuse together properly. Researchers measured pain relief and fusion success over 24 months.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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75 people
The number who actually took part.
- Started
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Apr 2021
- Finished
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Apr 2023
- 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 Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who: * Satisfied the inclusion and exclusion criteria * Signed the informed consent * Underwent the surgical procedure, as defined in this protocol Subjects not meeting any of these criteria will not be considered enrolled in the study, and therefore not included in any study population or analysis.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients who are ≥18 years of age at the time of consent 2. Planned interbody fusion surgery using the Decade Plate System in conjunction with an interbody implant to treat one or two levels in the thoracic and/or lumbar spine for 1. degenerative disc disease 2. spondylolisthesis 3. scoliosis, kyphosis, lordosis 4. spinal stenosis 5. spondylolysis 6. pseudoarthrosis or failed previous spine surgery 3. Able to undergo surgery based on physical exam, medical history, and surgeon judgment 4. Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study Exclusion Criteria: 1. Use of posterior fixation for the scheduled surgery Note: Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study 2. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested) 3. Use of bone growth stimulators postoperatively 4. Active smoking within 6 weeks before surgery 5. Patient has known sensitivity to materials implanted 6. Systemic or local infection (latent or active) or signs of local inflammation 7. Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment 8. Pregnant, or plans to become pregnant during the study 9. Patient is a prisoner 10. Patient is participating in another clinical study 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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Loma Linda University
Loma Linda, California, 92350, 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?