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

December 6, 2021 updated by: Encore Medical, L.P.

A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92120
        • Recruiting
        • SIOSD
        • Contact:
        • Contact:
          • Josephine Turner
    • New York
      • White Plains, New York, United States, 10604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects underwent primary anterior cervical discectomy and fusion (ACDF) and required two- level cervical spine fusions. OR were active smokers and required either single or two-level cervical spine fusions.

Description

Inclusion Criteria

  • Male or Female aged 18-75 years.
  • Primary anterior cervical discectomy fusion (ACDF) and required two level spinal fusion or were active smokers and required either single or two level spinal fusion.
  • Pain VAS score >5 and/or extreme weakness at target operative level(s).
  • At least one post operative clinical outcome assessment (VAS pain/ NDI/OC score) at each follow up interval.
  • Completed 6 month follow up visit or time to fusion assessment, whichever is sooner.

Exclusion Criteria

  • Treated with a bone growth stimulator device other than the SpinalogicTM CMF device.
  • Previous cervical vertebrae fusion surgery at any level (posterior or anterior approach)
  • Systemic administration of any type of corticosteroid, antineoplastic, immune- stimulating or immunosuppressive agents within 30 days of primary ACDF surgery and/or within 12 weeks post-operatively.
  • Active history of systemic malignancy at pre-operative assessment or during 12- month follow up period.
  • Untreated malignant neoplasm(s) or underwent radiotherapy or chemotherapy at pre- operative assessment or during 12-month follow up period.
  • Implanted with cardiac pacemaker or implantable cardioverter defibrillator at pre- operative assessment or during 12-month follow up period.
  • Pregnant at pre-operative assessment or during 12-month follow up period.
  • Mental or physical condition that would interfere with post-treatment assessments and/or care (e.g., neuromuscular disease, psychiatric disease,
  • Paraplegia, quadriplegia, etc.) at pre-operative assessment or during 12-month follow up period.
  • Prescribed non-steroidal anti-inflammatory, calcium channel blockers and/or diphosphonate therapy within 12-weeks of surgery period.
  • Prescribed bone morphogenic protein (BMP) during 12-month follow up period.
  • Implanted with a Titanium cage during the primary ACDF that precludes an outcome determination via plain radiographs.
  • Osseous or ligamentous spinal trauma at pre-operative assessment or during 12- month follow up period.
  • Paget's disease at pre-operative assessment or during 12-month follow up period.
  • Absence of X-ray fusion assessment documentation at 6 months follow-up visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treated
Patients who underwent ACDF surgery and who received post surgical therapy with the SpinalogicTM Non-Invasive Bone Graft Stimulation Device.
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.
Control
Patients who underwent ACDF surgery and did not receive post surgical Bone Graft Stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to fusion
Time Frame: 12 months
Comparison of the cervical fusion rate between treated and control group patients
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Reported Outcome Measures VAS
Time Frame: 12 months
VAS Pain Score
12 months
Patient Reported Outcome Measures NDI
Time Frame: 12 months
Neck Disability Index
12 months
Patient Reported Outcome Measures OC
Time Frame: 12 months
Odum's Criteria
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Encore Medical, L.P.

Collaborators

Medical Metrics Diagnostics, Inc

Investigators

  • Study Director: Ruba Sarris, MPH, DJO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 15, 2021

Primary Completion (ANTICIPATED)

March 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (ACTUAL)

November 1, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 7, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS-608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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