CompletedNot Applicable

SpineJack System Postmarket Registry

United States261 participantsStarted 2019-08-19

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Back pain

Timeframe: 12 months post-procedure

Radiological outcomes

Timeframe: Immeditely post-procedure

Radiological outcomes

Timeframe: Immediately post-procedure

Adverse events

Timeframe: 12 months post-procedure

Quality of life indices - Roland Morris Disability Questionnaire (RMDQ)

Timeframe: 12 months post-procedure

Patient-Reported Outcomes Measurement Information System (PROMIS Global-10)

Timeframe: 12 months post-procedure

NCT IDNCT04795765

SponsorStryker Instruments

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-11-11