Trials / Completed
CompletedNCT04795765
SpineJack System Postmarket Registry
Prospective SpineJack System Registry
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 261 (actual)
- Sponsor
- Stryker Instruments · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | SpineJack system | For use in the reduction of painful osteoporotic vertebral compression fractures. |
| PROCEDURE | Balloon kyphoplasty | Treatment of osteoporotic vertebral compression fractures. |
| PROCEDURE | Vertebroplasty | Treatment of osteoporotic vertebral compression fractures. |
Timeline
- Start date
- 2019-08-19
- Primary completion
- 2024-11-11
- Completion
- 2024-11-11
- First posted
- 2021-03-12
- Last updated
- 2024-12-10
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04795765. Inclusion in this directory is not an endorsement.