An observational study in Degenerative Disc Disease and Spinal Stenosis, sponsored by OssDsign. Recruiting at 16 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by OssDsign · Observational
The purpose of this multi-center, prospective, observational registry is to gather information on the clinical outcomes and real-world use of commercially available bone graft substitutes manufactured by OssDsign® AB, in patients who require spine fusion.
This multi-center study (up to 25 US study sites) is a post market, prospective, observational spine fusion registry. The outcomes of patients undergoing spine fusion with OssDsign® bone grafts will be documented and evaluated for the purposes of post market clinical follow up as part of OssDsign® post market surveillance activities. The length of study duration and number to be recruited is open-ended but initially a target of 750 subjects will be recruited and followed up for a period of 24 months ± 90 days after their index surgery in which an OssDsign® bone graft has been implanted.
462 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 450 is above the median of 119 across 170 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →OssDsign is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with as a candidate for spinal fusion surgery
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler
Rate of bone fusion
Assessment of the rate of bone fusion via Computerized Tomography (CT)/x-ray based on evidence of continuous bone bridging from the superior to the inferior vertebral body at the target level.
Time frame: 12 months ± 60 days post-operative examination
Quality of Life Questionnaire: Oswestry Disability Index
A questionnaire used to measure a patient's permanent functional disability scored 0-4, (no disability) to 35-50, (completely disabled).
Time frame: Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Neck Disability Index (NDI)
A self-reported questionnaire to determine how pain affects everyday life and assess the level of disability and scored from 0 (no disability) to 50 (complete disability).
Time frame: Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Visual Analog Scale (VAS)
A self rated pain scale from 0 (no pain) to 10 (worst imaginable pain)
Time frame: Up to 4 months, 6, 12 and 24 months
Quality of Life Questionnaire: Short Form 36 (SF-36)
A Questionnaire used to measure the impact of clinical and social interventions using eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability, higher scores = less disability
Time frame: Up to 4 months, 6, 12 and 24 months
Neurological Function
All subjects will be assessed for sensory, reflex, and muscle strength (motor) by the clinician
Time frame: Up to 4 months, 6, 12 and 24 months
Presence of bone fusion
All subjects will undergo x-ray evaluation to include AP and neutral lateral views pre-operatively. At post-operative visits AP and neutral lateral x-rays, plus flexion and extension x-rays (if standard care) taken with the subject standing up and/or a CT scan taken.
Time frame: 6, 12 and 24 months
Safety review of device related AE's
Review of Adverse Events
Time frame: Throughout study, 24 months
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Intervertebral Disc Degeneration →
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