Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05101057
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Encore Medical, L.P.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Ruba Sarris, MPH
Principal Investigator Affiliation DJO
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Degeneration of Cervical Intervertebral Disc
Arms & Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

SIOSD, San Diego, California

Status

Recruiting

Address

SIOSD

San Diego, California, 92120

Site Contact

Ramin Raiszadeh, MD

[email protected]

619-265-7912

BSSNY, White Plains, New York

Status

Recruiting

Address

BSSNY

White Plains, New York, 10604

Site Contact

John Abrahams, MD

[email protected]

914-345-8111

Powered By