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

NCT05101057 | Unknown FDA Device

• 1 other identifier: PS-608
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Time to fusion

  Comparison of the cervical fusion rate between treated and control group patients

  12 months

Secondary Outcomes (3)

• Patient Reported Outcome Measures VAS

  12 months

• Patient Reported Outcome Measures NDI

  12 months

• Patient Reported Outcome Measures OC

  12 months

Study Arms (2)

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

Control

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

Interventions

SpinalogicTM Bone Graft Stimulator DEVICE

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.

Treated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Encore Medical, L.P.: lead
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (2)

SIOSD

San Diego, California, 92120, United States

RECRUITING

BSSNY

White Plains, New York, 10604, United States

RECRUITING

Related Publications (7)

• Marquez-Lara A, Nandyala SV, Fineberg SJ, Singh K. Current trends in demographics, practice, and in-hospital outcomes in cervical spine surgery: a national database analysis between 2002 and 2011. Spine (Phila Pa 1976). 2014 Mar 15;39(6):476-81. doi: 10.1097/BRS.0000000000000165.

  PMID: 24365907 BACKGROUND

• Eck JC, Hodges SD, Humphreys SC. Techniques for stimulating spinal fusion: efficacy of electricity, ultrasound, and biologic factors in achieving fusion. Am J Orthop (Belle Mead NJ). 2001 Jul;30(7):535-41.

  PMID: 11482508 BACKGROUND

• Gruskay JA, Webb ML, Grauer JN. Methods of evaluating lumbar and cervical fusion. Spine J. 2014 Mar 1;14(3):531-9. doi: 10.1016/j.spinee.2013.07.459. Epub 2013 Oct 31.

  PMID: 24183750 BACKGROUND

• Veeravagu A, Cole T, Jiang B, Ratliff JK. Revision rates and complication incidence in single- and multilevel anterior cervical discectomy and fusion procedures: an administrative database study. Spine J. 2014 Jul 1;14(7):1125-31. doi: 10.1016/j.spinee.2013.07.474. Epub 2013 Oct 11.

  PMID: 24126076 BACKGROUND

• Leven D, Cho SK. Pseudarthrosis of the Cervical Spine: Risk Factors, Diagnosis and Management. Asian Spine J. 2016 Aug;10(4):776-86. doi: 10.4184/asj.2016.10.4.776. Epub 2016 Aug 16.

  PMID: 27559462 BACKGROUND

• Hilibrand AS, Fye MA, Emery SE, Palumbo MA, Bohlman HH. Impact of smoking on the outcome of anterior cervical arthrodesis with interbody or strut-grafting. J Bone Joint Surg Am. 2001 May;83(5):668-73. doi: 10.2106/00004623-200105000-00004.

  PMID: 11379735 BACKGROUND

• Campbell PG, Yadla S, Nasser R, Malone J, Maltenfort MG, Ratliff JK. Patient comorbidity score predicting the incidence of perioperative complications: assessing the impact of comorbidities on complications in spine surgery. J Neurosurg Spine. 2012 Jan;16(1):37-43. doi: 10.3171/2011.9.SPINE11283. Epub 2011 Oct 28.

  PMID: 22035101 BACKGROUND

Study Officials

• Ruba Sarris, MPH

  DJO

  STUDY DIRECTOR

Central Study Contacts

CLAIRE D WILLIAMS, MA

CONTACT

19789964243; Claire.Willams8@djoglobal.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: November 1, 2021
• Study Start: November 15, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 7, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)