A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients
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|ClinicalTrials.gov Identifier: NCT05101057|
Recruitment Status : Recruiting
First Posted : November 1, 2021
Last Update Posted : December 7, 2021
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|Condition or disease||Intervention/treatment|
|Degeneration of Cervical Intervertebral Disc||Device: SpinalogicTM Bone Graft Stimulator|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|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|
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.
Patients who underwent ACDF surgery and did not receive post surgical Bone Graft Stimulation.
- Time to fusion [ Time Frame: 12 months ]Comparison of the cervical fusion rate between treated and control group patients
- Patient Reported Outcome Measures VAS [ Time Frame: 12 months ]VAS Pain Score
- Patient Reported Outcome Measures NDI [ Time Frame: 12 months ]Neck Disability Index
- Patient Reported Outcome Measures OC [ Time Frame: 12 months ]Odum's 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|
- 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.
- 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.
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
|Contact: CLAIRE D WILLIAMS, MA||19789964243||Claire.Willams8@djoglobal.com|
|United States, California|
|San Diego, California, United States, 92120|
|Contact: Ramin Raiszadeh, MD 619-265-7912 email@example.com|
|Contact: Josephine Turner|
|United States, New York|
|White Plains, New York, United States, 10604|
|Contact: John Abrahams, MD 914-345-8111 firstname.lastname@example.org|
|Contact: Rami Elsabeh 19143458111 ext 7909 email@example.com|
|Study Director:||Ruba Sarris, MPH||DJO|
|Responsible Party:||Encore Medical, L.P.|
|Other Study ID Numbers:||
|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|
|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|