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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OssDsign® Catalyst | Device | An osteoconductive, resorbable, porous, 100 % nano synthetic calcium phosphate bone void filler |
| 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 |
| 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) |
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Exclusion Criteria:
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Patients diagnosed with as a candidate for spinal fusion surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jeff Feldhaus | Contact | 13476694903 | jfeldhaus@msquaredassociates.com | |
| Pete weiman | Contact | 13479540542 | pete.weiman@propharmagroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Melanie Marshall | OssDsign | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Health Partners Neuroscience | Recruiting | Fresno | California | 93720 | United States |
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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 |
| Memorial Orthopaedic Surgical Group | Recruiting | Long Beach | California | 90806 | United States |
|
| San Diego Neurosurgery | Terminated | San Diego | California | 92024 | United States |
| Orthopedic Associates of Hartford | Active, not recruiting | Hartford | Connecticut | 06102 | United States |
| Central Connecticut Neurosurgery and Spine | Recruiting | New Britian | Connecticut | 06051 | United States |
|
| Yale Center for Clinical Investigation, Yale School of Medicine | Recruiting | New Haven | Connecticut | 06519 | United States |
|
| Minimally Invasive Spine Center of South Florida | Recruiting | Miami | Florida | 33133 | United States |
|
| Foundation for Orthopaedic Research and Education | Recruiting | Tampa | Florida | 33607 | United States |
|
| Northeast Georgia Medical Center | Active, not recruiting | Gainesville | Georgia | 30501 | United States |
| Carle Foundation Hospital, NeuroScience Institute | Completed | Urbana | Illinois | 61801 | United States |
| Orthopaedic Institute of Western Kentucky | Completed | Paducah | Kentucky | 42001 | United States |
| OrthoBethesda Research Foundation | Active, not recruiting | Bethesda | Maryland | 20817 | United States |
| Twin Cities Orthopedics | Active, not recruiting | Edina | Minnesota | 55435 | United States |
| University Orthopedics Center | Recruiting | State College | Pennsylvania | 16801 | United States |
|
| Texas Spine Consultants | Not yet recruiting | Addison | Texas | 75001 | United States |
|
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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