Recruiting

CMF Stimulation

Sponsor:

Encore Medical, L.P.

Code:

NCT05101057

Conditions

Degeneration of Cervical Intervertebral Disc

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SpinalogicTM Bone Graft Stimulator

Study Details

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.

Conditions

Degeneration of Cervical Intervertebral Disc

Study ID

NCT05101057

Start date

Nov 15, 2021

Status verified date

Oct, 2021

Completion date

Jun 1, 2022

Anticipated

Primary completion date

Mar 1, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Treated

Patients who underwent ACDF surgery and who received post surgical therapy with the SpinalogicTM Non-Invasive Bone Graft Stimulation Device.

Control

Patients who underwent ACDF surgery and did not receive post surgical Bone Graft Stimulation.

Interventions

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.

Primary outcome measure

  • Time to fusion [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

CLAIRE D WILLIAMS, MA

19789964243Claire.Willams8@djoglobal.com

Locations

SIOSD

Recruiting

San Diego, California, United States, 92120

Contacts

Ramin Raiszadeh, MD

619-265-7912ramin@siosd.com

BSSNY

Recruiting

White Plains, New York, United States, 10604

Contacts

John Abrahams, MD

914-345-8111jabrahams@bssny.com

Rami Elsabeh

19143458111relsabeh@bssny.com

More Information

Sponsor

Encore Medical, L.P.

Last update posted

Dec 7, 2021

Last verified

Oct, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Encore Medical, L.P. on 2021-12-07.