OssDsign® Spine Registry Study (Propel)

Study Overview
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Brief Summary
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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.

Detailed Description
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This multi-center study (up to 10 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 300 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.

Official Title
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PROSPECTIVE OBSERVATIONAL SPINE FUSION REGISTRY FOR OssDsign® BONE GRAFT SUBSTITUTES IN REAL WORLD CLINICAL PRACTICE

Conditions
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Degenerative Disc Disease, Spinal Stenosis

Intervention / Treatment
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* Device: OssDsign® Catalyst


Participation Criteria
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Eligibility Criteria
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The patient has been diagnosed as a candidate for spinal fusion surgery for which the surgeon has decided an OssDsign® bone graft is appropriate. The patient is ≥21 years old. The patient is, in the investigator's opinion, psychosocially, mentally, and physically able to fully comply with this protocol, including the post-operative regimen, required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent The patient is willing and able to participate in post- operative clinical and radiographic follow up evaluations for 2 years. Exclusion Criteria: Patients not meeting all of the inclusion criteria

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OssDsign® Catalyst|An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months ± 60 days post-operative examination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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) | 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 | 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 | 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. | 6, 12 and 24 months | 
| Safety review of device related AE's | Review of Adverse Events | Throughout study, 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Synthetic bone grafts, Degenerative Disc Disease, Bone fusion