ReActiv8 Post Market Surveillance Registry

Completed

• Conditions: Chronic Low Back Pain

• Registration Number: NCT03255200
• Lead Sponsor: Mainstay Medical

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-17
• Study First Posted: 2017-08-21
• Study Start: 2017-10-09
• Primary Completion: 2023-03-20
• Study Completion: 2023-12-08
• Results First Submitted: 2024-05-30
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Results First Posted: 2024-10-16
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Low Back Pain - Numeric Pain Rating (NRS) Scale	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 Outcome Measures

Name	Time	Method
Serious Adverse Device Effects	Through 2 years post Activation	All serious device- or procedure-related adverse events.

Trial Locations

Locations (5)

Katholisches Klinikum Koblenz; 🇩🇪 Koblenz, Germany

Orthopadisches Krankenhaus Schloss Werneck; 🇩🇪 Werneck, Balthasar-Neumann, Germany

Klinikum Magdeburg; 🇩🇪 Magdeburg, Germany

Medizinisches Versorgungszentrum Steinburg gGmbH; 🇩🇪 Itzehoe, Germany

BG Klinikum Bergmannstrost; 🇩🇪 Halle, Germany