ReActiv8 Post Market Surveillance Registry

Mainstay Medical87 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Low Back Pain

Interventions

ReActiv8 Implantable Stimulation SystemDEVICE

Implantable electrical stimulation system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Meet the Indications for ReActiv8 2. Willing to sign the Informed Consent for the Registry 3. Age ≥ 18 years Exclusion Criteria: 1\. Subjects will be excluded from the Registry if they are contraindicated for ReActiv8.

Locations (5)

Orthopadisches Krankenhaus Schloss Werneck

Werneck, Balthasar-Neumann, Germany

BG Klinikum Bergmannstrost

Halle, Germany

Medizinisches Versorgungszentrum Steinburg gGmbH

Itzehoe, Germany

Katholisches Klinikum Koblenz

Koblenz, Germany

Outcomes

Primary Outcomes

Low Back Pain - Numeric Pain Rating (NRS) Scale

Change in low back pain Numerical Rating Scale (NRS) compared to Baseline. The NRS is an 11-point scale where 0 means no pain at all and 10 means worst imaginable pain. Patients were asked to rate their average low back pain in the last 24 hours. Lower scores or reduction in score means an improvement or reduction in pain.

Time frame: 90 days, 180 days, 1 year, 2 years post Activation

Secondary Outcomes

Serious Adverse Device Effects

All serious device- or procedure-related adverse events.

Time frame: Through 2 years post Activation

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.