SpineJack System Postmarket Registry

Stryker

Status: Completed

Conditions: Osteoporotic Vertebral Compression Fractures

Treatments: Procedure: Vertebroplasty; Procedure: SpineJack system; Procedure: Balloon kyphoplasty

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT04795765

SISSJS2019US

Details and patient eligibility

About

This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.

Full 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.

Enrollment: 261 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. Understand and sign the informed consent form (as applicable)
3. Exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (PRO) surveys following the procedure.
4. VCF diagnosis made and/or confirmed at participating site.

Exclusion criteria

Trial design

261 participants in 2 patient groups

Patients treated with SpineJack system

Description:

SpineJack system procedure

Treatment:

Procedure: SpineJack system

Patients treated with vertebral augmentation

Description:

Vertebral augmentation procedures may include either balloon kyphoplasty (BKP) or vertebroplasty (VP).

Treatment:

Procedure: Balloon kyphoplasty

Procedure: Vertebroplasty