ReActiv8 Post Market Surveillance Registry

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.

Completed

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Key information

Conditions

Chronic Low Back Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Orthopadisches Krankenhaus Schloss Werneck, Werneck, Balthasar-Neumann, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ReActiv8 Implantable Stimulation System

Device

Implantable electrical stimulation system.

Primary outcomes

Low Back Pain - Numeric Pain Rating (NRS) Scale

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

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.

Secondary outcomes

Serious Adverse Device Effects

Time frame: Through 2 years post Activation

All serious device- or procedure-related adverse events.

Sponsors and collaborators

Lead sponsor

Mainstay Medical

Industry

Registry information

Official study title

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

Acronym: ReActiv8-C

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Aug 21, 2017
Registry last updated: Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed