An observational study in Spinal Disease and Degenerative Disc Disease, sponsored by Collagen Matrix. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-16.
Sponsored by Collagen Matrix · Observational
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material. The primary endpoints are radiographic evidence of fusion and the absence of serious adverse events attributable to OssiMend Bioactive Moldable. The secondary objective is to evaluate the clinical outcomes over a period of 1 year (2 years, if possible).
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 120 is close to the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →Collagen Matrix is the lead sponsor of 7 studies on the registry; 5 are open to participants now.
Compared within Intervertebral Disc Degeneration, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Subjects must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject must be 18 years of age or older at the time of consent and must have a documented diagnosis of degenerative disc disease (DDD) that has failed to respond to nonoperative treatment for at least 6 months. DDD is defined by back and/or radicular pain with degeneration of the disc as confirmed by medical history, physical examination, and radiographic studies that may include CT, MRI, plain X-ray film, discography, myelography, etc. with one or more of the following findings:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing Lumber Spine Fusion
Device: OssiMend™ Bioactive Moldable
Lumbar Spine fusion with OssiMend™ Bioactive Moldable
Fusion Success
Fusion will be assessed with A/P and Lateral radiographs taken and scored with Lenke's classification of posterolateral fusion success
Time frame: 12 months
Visual analog scale (VAS) of back and leg (left and right)
Improvement of pain as defined by the Visual analog scale (VAS) of back and leg (left and right)
Time frame: 12 months
Oswestry Lower Back Pain Questionnaire
Pain/Disability as measured by Oswestry Lower Back Pain Questionnaire
Time frame: 12 months
SF36
Pain and function as measured by the Short - Form 36
Time frame: 12 months
Not enrolling at this site.
Plan to share: No
Started Jan 2021 (actual). Primary completion is estimated for Dec 2026, 71 months after the start.
Of 80 observational studies under Intervertebral Disc Degeneration, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 45 and three quarters within 84. This study's planned 71 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Intervertebral Disc Degeneration →
Collagen Matrix