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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05101057
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : December 7, 2021
Sponsor:
Collaborator:
Medical Metrics Diagnostics, Inc
Information provided by (Responsible Party):
Encore Medical, L.P.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Degeneration of Cervical Intervertebral Disc Device: SpinalogicTM Bone Graft Stimulator

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients
Actual Study Start Date : November 15, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : June 1, 2022
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to fusion [ Time Frame: 12 months ]
    Comparison of the cervical fusion rate between treated and control group patients


Secondary Outcome Measures :
  1. Patient Reported Outcome Measures VAS [ Time Frame: 12 months ]
    VAS Pain Score

  2. Patient Reported Outcome Measures NDI [ Time Frame: 12 months ]
    Neck Disability Index

  3. Patient Reported Outcome Measures OC [ Time Frame: 12 months ]
    Odum's Criteria


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05101057


Contacts
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Contact: CLAIRE D WILLIAMS, MA 19789964243 Claire.Willams8@djoglobal.com

Locations
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United States, California
SIOSD Recruiting
San Diego, California, United States, 92120
Contact: Ramin Raiszadeh, MD    619-265-7912    ramin@siosd.com   
Contact: Josephine Turner         
United States, New York
BSSNY Recruiting
White Plains, New York, United States, 10604
Contact: John Abrahams, MD    914-345-8111    jabrahams@bssny.com   
Contact: Rami Elsabeh    19143458111 ext 7909    relsabeh@bssny.com   
Sponsors and Collaborators
Encore Medical, L.P.
Medical Metrics Diagnostics, Inc
Investigators
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Study Director: Ruba Sarris, MPH DJO
More Information
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Publications:

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Responsible Party: Encore Medical, L.P.
ClinicalTrials.gov Identifier: NCT05101057    
Other Study ID Numbers: PS-608
First Posted: November 1, 2021    Key Record Dates
Last Update Posted: December 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Spinal Diseases
Bone Diseases
Musculoskeletal Diseases