N/A
Completed N=87
ReActiv8 Post Market Surveillance Registry
Source: ClinicalTrials.gov NCT03255200 ↗Enrolled (actual)
87
Serious AEs
24.1%
Results posted
Oct 2024
Primary outcomePrimary: Low Back Pain - Numeric Pain Rating (NRS) Scale — 4.5; 4.3; 3.8; 3.4 units on a scale
Summary
To gather data on the long-term safety of ReActiv8 and identify any residual risks by reporting all Serious Adverse Device Effects as well as performance and health care utilization through two years post-implant.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low Back Pain - Numeric Pain Rating (NRS) Scale |
4.5; 4.3; 3.8; 3.4 | — |
| SECONDARY Serious Adverse Device Effects |
— | — |
Eligibility Criteria
Inclusion Criteria
- Meet the Indications for ReActiv8
- Willing to sign the Informed Consent for the Registry
- Age ≥ 18 years
Exclusion Criteria
- Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.
Data sourced from ClinicalTrials.gov (NCT03255200). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.