Degenerative Disc Disease, Spinal Stenosis
Conditions
Keywords
Synthetic bone grafts, Degenerative Disc Disease, Bone fusion
Brief summary
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
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.
Interventions
DEVICEOssDsign® Catalyst
An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler
Sponsors
OssDsign
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of bone fusion | 12 months ± 60 days post-operative examination | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Questionnaire: Oswestry Disability Index | Up to 4 months, 6, 12 and 24 months | A questionnaire used to measure a patient's permanent functional disability scored 0-4, (no disability) to 35-50, (completely disabled). |
| Quality of Life Questionnaire: Neck Disability Index (NDI) | Up to 4 months, 6, 12 and 24 months | 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). |
| Quality of Life Questionnaire: Visual Analog Scale (VAS) | Up to 4 months, 6, 12 and 24 months | A self rated pain scale from 0 (no pain) to 10 (worst imaginable pain) |
| Quality of Life Questionnaire: Short Form 36 (SF-36) | Up to 4 months, 6, 12 and 24 months | 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 |
| Neurological Function | Up to 4 months, 6, 12 and 24 months | All subjects will be assessed for sensory, reflex, and muscle strength (motor) by the clinician |
| Presence of bone fusion | 6, 12 and 24 months | 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. |
| Safety review of device related AE's | Throughout study, 24 months | Review of Adverse Events |
Countries
United States
Contacts
CONTACTjeff Feldhaus
CONTACTPete weiman
STUDY_DIRECTORMelanie Marshall
OssDsign
Outcome results
None listed