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A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients

NCT05101057 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2021-12-07

No results posted yet for this study

Summary

A retrospective parallel group comparison study to support expansion of the indication of the company's FDA approved Spinalogic™ device to include the cervical spine. The SpinalogicTM device was initially approved by FDA as an adjunct to one- or two-level lumbar fusion (P910066/S011). It is a non-invasive bone growth stimulator (BGS) that generates a combined magnetic field (CMF) that has been proven to accelerate bone healing and fusion in the lumbar spine.

Conditions

  • Degeneration of Cervical Intervertebral Disc

Interventions

DEVICE

SpinalogicTM Bone Graft Stimulator

The SpinalogicTM is a portable, battery-powered, microprocessor-controlled, non-invasive bone growth stimulator. The device is currently approved and commercially indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels.

Sponsors & Collaborators

  • Medical Metrics Diagnostics, Inc

    collaborator INDUSTRY

  • Encore Medical, L.P.

    lead INDUSTRY

Principal Investigators

  • Ruba Sarris, MPH · DJO

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-15
Primary Completion
2022-03-01
Completion
2022-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05101057 on ClinicalTrials.gov