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| Name | Class |
|---|---|
| Talosix | UNKNOWN |
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This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
The SpineJack System Registry will employ a prospective, multicenter, observational, consecutive enrollment design. The sample size for this Registry will include at least 400 patients treated for VCFs across approximately 10 sites. A total of 240 patients will be treated with the SpineJack system and 160 patients will be treated with other vertebral augmentation (VA) procedures, such as BKP or VP. Sites within the U.S. may include healthcare professionals (HCPs) that are surgeons, pain physicians and/or interventional radiologists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients treated with SpineJack system | SpineJack system procedure |
| |
| Patients treated with vertebral augmentation | Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpineJack system | Procedure | For use in the reduction of painful osteoporotic vertebral compression fractures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Back pain | The numeric rating scale consists of an eleven-point scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). | 12 months post-procedure |
| Radiological outcomes | Vertebral body height restoration | Immeditely post-procedure |
| Radiological outcomes | Adjacent level fractures | Immediately post-procedure |
| Adverse events |
| 12 months post-procedure |
| Quality of life indices - Roland Morris Disability Questionnaire (RMDQ) | 24-item self-report questionnaire used in patients with mild to moderate disability due to acute, sub-acute or chronic low back pain | 12 months post-procedure |
| Patient-Reported Outcomes Measurement Information System (PROMIS Global-10) | 10-item questionnaire that is used to assess general domains of health and functioning, including overall physical health, mental health, social health, pain, fatigue and overall perceived quality of life | 12 months post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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All eligible patients that meet inclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Diego Neurosurgery | Encinitas | California | 92024 | United States | ||
| California Orthopedics and Spine |
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| ID | Term |
|---|---|
| D058498 | Kyphoplasty |
| D054854 | Vertebroplasty |
| ID | Term |
|---|---|
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Balloon kyphoplasty | Procedure | Treatment of osteoporotic vertebral compression fractures. |
|
| Vertebroplasty | Procedure | Treatment of osteoporotic vertebral compression fractures. |
|
| Larkspur |
| California |
| 94939 |
| United States |
| Cleveland Clinic | Stuart | Florida | 34994 | United States |
| St. Luke's IntermountainResearch Center | Boise | Idaho | 83702 | United States |
| Dartmouth Hitchcock | Lebanon | New Hampshire | 03756 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| Clinical Investigations | Edmond | Oklahoma | 73013 | United States |
| Center for Diagnostic Imaging (CDI) | Puyallup | Washington | 98373 | United States |
| Rainier Orthopedic Institute | Puyallup | Washington | 98374 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |