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

Status unconfirmed

Conditions studied: Degeneration of Cervical Intervertebral Disc

In brief

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.

Key facts

Study ID

NCT05101057

Run by

Encore Medical, L.P.

People needed

400

Starts

2021-11-15

Expected to finish

2022-06-01

Last updated by the study team

2021-12-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• SIOSD — San Diego, California, United States (enrolling)
• BSSNY — White Plains, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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