ReActiv8 Post Market Surveillance Registry (ReActiv8-C)

ReActiv8 Post Market Surveillance Registry for the ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

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 Overview

• Status: Completed
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: ReActiv8 Implantable Stimulation System

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• Germany
  • Halle, Germany
    • BG Klinikum Bergmannstrost
  • Itzehoe, Germany
    • Medizinisches Versorgungszentrum Steinburg gGmbH
  • Koblenz, Germany
    • Katholisches Klinikum Koblenz
  • Magdeburg, Germany
    • Klinikum Magdeburg
  • Balthasar-Neumann
    • Werneck, Balthasar-Neumann, Germany, 97440
      • Orthopadisches Krankenhaus Schloss Werneck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population for this registry is persons with chronic low back pain who are indicated for ReActiv8.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	90 days, 180 days, 1 year, 2 years post Activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serious Adverse Device Effects	All serious device- or procedure-related adverse events.	Through 2 years post Activation

Collaborators and Investigators

• Sponsor: Mainstay Medical
• Investigators: Principal Investigator: Stefan Schu, MD, SANA Klinikum Duisburg

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): March 20, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 16, 2024
• Last Update Submitted That Met QC Criteria: October 14, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 950066