Degeneration of Cervical Intervertebral DiscNCT05101057
A Retrospective Study to Examine the Effect of CMF Stimulation on Primary ACDF Patients
An observational study of Degeneration of Cervical Intervertebral Disc, run by Encore Medical, L.P. at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Degeneration of Cervical Intervertebral Disc
- What is being tested?
- SpinalogicTM Bone Graft Stimulator
- Type of treatment
- Medical device
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2021to 1 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
SIOSD
San Diego, California, 92120
Ramin Raiszadeh, MD, 619-265-7912, ramin@siosd.com
Josephine Turner
- Recruiting
BSSNY
White Plains, New York, 10604
John Abrahams, MD, 914-345-8111, jabrahams@bssny.com
Rami Elsabeh, 19143458111 ext. 7909, relsabeh@bssny.com
About this study
Official title: A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients
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.
- Being tested
- SpinalogicTM Bone Graft Stimulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpinalogicTM Bone Graft StimulatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Patients who underwent ACDF surgery and who received post surgical therapy with the SpinalogicTM Non-Invasive Bone Graft Stimulation Device. Receives: Device: SpinalogicTM Bone Graft Stimulator | |
| Control | Patients who underwent ACDF surgery and did not receive post surgical Bone Graft Stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to fusion
Comparison of the cervical fusion rate between treated and control group patients
Measured: 12 months
Secondary outcomes (3)
Patient Reported Outcome Measures VAS
VAS Pain Score
Measured: 12 months
Patient Reported Outcome Measures NDI
Neck Disability Index
Measured: 12 months
Patient Reported Outcome Measures OC
Odum's Criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start15 Nov 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Degeneration of Cervical Intervertebral DiscStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encore Medical, L.P.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Ruba Sarris, MPH, Study director, DJO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101057
- Sponsor's protocol ID
- PS-608
- Status last verified
- Oct 2021
- First submitted
- 19 Oct 2021
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24365907Eck 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.
PubMed 11482508Gruskay 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.
PubMed 24183750Veeravagu 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.
PubMed 24126076Leven 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.
PubMed 27559462Hilibrand 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.
PubMed 11379735Campbell 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.
PubMed 22035101
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study to Examine the Effect of Adjuvant Combined Magnetic Field Stimulation on Primary Anterior Cervical Discectomy and Fusion (ACDF) Patients
- ClinicalTrials.gov ID
- NCT05101057
- Acronym / sponsor ID
- PS-608
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Encore Medical, L.P.Industry (pharma, biotech, devices)
- Collaborators
- Medical Metrics Diagnostics, Inc
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 1 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treated | – | Device: SpinalogicTM Bone Graft StimulatorPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpinalogicTM Bone Graft StimulatorThe 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. | Device | Treated |
Primary outcome
Time to fusion
Time frame: 12 months
Comparison of the cervical fusion rate between treated and control group patients
3 secondary outcomes
Patient Reported Outcome Measures VAS
Time frame: 12 months
Patient Reported Outcome Measures NDI
Time frame: 12 months
Patient Reported Outcome Measures OC
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Background: PubMed 24365907Marquez-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.
- Background: PubMed 11482508Eck 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.
- Background: PubMed 24183750Gruskay 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.
- Background: PubMed 24126076Veeravagu 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.
- Background: PubMed 27559462Leven 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.
- Background: PubMed 11379735Hilibrand 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.
- Background: PubMed 22035101Campbell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruba Sarris, MPH study director
DJO
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration of Cervical Intervertebral Disc, run by Encore Medical, L.P. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CLAIRE D WILLIAMS, MA (19789964243, Claire.Willams8@djoglobal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to fusion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05101057, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2021.