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Lumbar Spine DegenerationNCT03176303

Study Using the SpinalStim Device Following Lumbar Fusion Surgery

An observational study of Lumbar Spine Degeneration, run by Orthofix Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study examines the effect of adjunctive use of the SpinalStim bone growth stimulator on lumbar fusion rate in high risk subjects who have had lumbar fusion surgery. All participants will wear the bone growth stimulator for a minimum of 2 hours/day for 6 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lumbar Spine Degeneration
What is being tested?
SpinalStim
Type of treatment
Medical device
How many people
206 participants
Where
1 siteUnited States
Study dates
28 Jun 2017to 12 Jul 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: subjects from all over the United States are eligible for enrollment as long as they meet the inclusion/exclusion criteria.

Who may be able to join

  • Male or female, ≥ 18 years of age at the time of Informed Consent
  • Requires a lumbar fusion surgery within 30 days of signing Informed Consent.
  • Surgical approach is according to physician's discretion.
  • Subject has one or more risk factors:
  • Is currently using nicotine
  • multi-level lumbar fusion surgery planned
Show all 13Show fewer
  • Prior failed fusion at any lumbar level
  • Subject reported diabetes
  • Subject reported osteoporosis
  • Body mass index ≤ 45 kg/m2 at the time of consent.
  • Must have reliable access to an iPhone or an iPad with Wi-Fi access for downloading the free device-specific app (iPhone 5S or higher, iPad, iPad Pro, iPad mini or iTouch using iOS v9.3 or later). When the android version of the mobile app for the SpinalStim becomes available (estimated to be Dec. 2017), subjects who have reliable access to devices using android operating systems will be eligible for study inclusion.
  • Able and willing to complete electronic questionnaires and able to read and understand study instructions in English
  • Able and willing to comply with the study plan and able to understand and sign the study-specific ICF.

Who cannot join

  • Scoliosis greater than 30 degrees
  • Current alcoholism or drug abuse, and/or any known current addiction to pain medications or medical marijuana
  • Any active malignancy or prior history of malignancy within last 5 years prior to fusion (except basal cell carcinoma of the skin).
  • Any clinically significant finding that places the subject at health risk, impacts the study, or affects completion of the study, in the opinion of the Investigator
  • Any psychiatric illness that prevents subject from completing the assessments accurately, in the opinion of the Investigator
  • Prisoners.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • ClinTech Center for Spine Health

    Johnstown, Colorado, 80534

Other trials in United States

About this study

Official title: A Multi-Center, Open-Label, Prospective Study of SpinalStim™ (MOP-SS) as Adjunctive Care Following Lumbar Fusion Surgery

This study examines the effect of adjunctive use of the SpinalStim bone growth stimulator on lumbar fusion rate in high risk subjects who have had lumbar fusion surgery. All participants will wear the bone growth stimulator for a minimum of 2 hours/day for 6 months.

Read the detailed description

The purpose of this post market prospective study is to examine the effect of the adjunctive use of the Orthofix SpinalStim™ device on lumbar fusion rate in high risk subjects who have undergone lumbar fusion surgery. High risk subjects are those who are currently using nicotine, who are having a multi-level fusion, who have had a prior failed fusion at any lumbar level, who are diabetic or who are osteoporotic. Because this is a post market prospective study, subjects who are enrolled in this study will be identified by the Investigator as needing lumbar fusion surgery and asked if they would like to participate in a study looking at the efficacy of lumbar fusion with adjunctive use of the SpinalStim bone growth simulator. The type of lumbar fusion surgery performed (lateral lumbar interbody fusion [XLIF], posterior lumbar interbody fusion [PLIF], anterior lumbar interbody fusion [ALIF], posterolateral fusion) is up to the Investigator; the subjects in the study must be agreeable to using the bone growth stimulator daily for 6 months post surgery.

Being tested
SpinalStim

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpinalStimDevice

    PEMF osteogenesis stimulator

Study groups in NCT03176303
Study groupRoleWhat they receive
Pulsed Electromagnetic Fieldone group all of whom will be treated with the PEMF device
Receives: Device: SpinalStim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fusion rate

    number of subjects with fused lumbar vertebrae, determined by X-rays and CT scans

    Measured: 12 months

Secondary outcomes (6)

  1. Device compliance

    actual minutes per day device was used compared with prescribed treatment time

    Measured: 6 months

  2. revision rate

    how many subjects had to be reoperated (revised) at the same level(s) during the course of the study

    Measured: 12 months

  3. SF-36

    used to assess the effect of PEMF treatment on subject quality of life

    Measured: 12 months

  4. Oswestry Disability Index

    used to examine the effect of PEMF treatment on subject disability

    Measured: 12 months

  5. VAS pain

    used to assess the effect of PEMF treatment on reduction of pain

    Measured: 12 months

  6. EQ-5D

    used to assess the effect of PEMF treatment on quality of life and economic impact

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start28 Jun 2017
  3. Primary completion12 Jul 2021
  4. Study completion12 Jul 2021

Resources

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
Prospective
Enrolment
206 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03176303
Sponsor's protocol ID
CP-1702SSPM
Status last verified
Sep 2022
First submitted
27 Apr 2017
Last updated
16 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
Individual data sharing
Undecided: if we decide to share, we will only share deidentified summary data

Publications

  • Weinstein MA, Beaumont A, Campbell P, Hassanzadeh H, Patel V, Vokshoor A, Wind J, Radcliff K, Aleem I, Coric D. Pulsed Electromagnetic Field Stimulation in Lumbar Spine Fusion for Patients With Risk Factors for Pseudarthrosis. Int J Spine Surg. 2023 Dec 26;17(6):816-823. doi: 10.14444/8549.

    PubMed 37884337

Questions about this trial

What is this clinical trial studying?

An observational study of Lumbar Spine Degeneration, run by Orthofix Inc. at 1 site 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 13 inclusion and 6 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: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fusion rate (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 NCT03176303, which also lists 1 linked publication.

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 16 Sep 2022.

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