Study Using the SpinalStim Device Following Lumbar Fusion Surgery

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.

Study Overview

• Status: Completed
• Conditions: Lumbar Spine Degeneration
• Intervention / Treatment: Device: SpinalStim

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.

• Study Type: Observational
• Enrollment (Actual): 206

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Johnstown, Colorado, United States, 80534
      • ClinTech Center for Spine Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

1. Male or female, ≥ 18 years of age at the time of Informed Consent

2. Requires a lumbar fusion surgery within 30 days of signing Informed Consent.

   a. Surgical approach is according to physician's discretion.

3. Subject has one or more risk factors:

   • Is currently using nicotine
   • multi-level lumbar fusion surgery planned
   • Prior failed fusion at any lumbar level
   • Subject reported diabetes
   • Subject reported osteoporosis
4. Body mass index ≤ 45 kg/m2 at the time of consent.
5. 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.
6. Able and willing to complete electronic questionnaires and able to read and understand study instructions in English
7. Able and willing to comply with the study plan and able to understand and sign the study-specific ICF.

Exclusion Criteria:

1. Scoliosis greater than 30 degrees
2. Current alcoholism or drug abuse, and/or any known current addiction to pain medications or medical marijuana
3. Any active malignancy or prior history of malignancy within last 5 years prior to fusion (except basal cell carcinoma of the skin).
4. 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
5. Any psychiatric illness that prevents subject from completing the assessments accurately, in the opinion of the Investigator
6. Prisoners.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulsed Electromagnetic Field; one group all of whom will be treated with the PEMF device	Device: SpinalStim; PEMF osteogenesis stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
fusion rate	number of subjects with fused lumbar vertebrae, determined by X-rays and CT scans	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device compliance	actual minutes per day device was used compared with prescribed treatment time	6 months
revision rate	how many subjects had to be reoperated (revised) at the same level(s) during the course of the study	12 months
SF-36	used to assess the effect of PEMF treatment on subject quality of life	12 months
Oswestry Disability Index	used to examine the effect of PEMF treatment on subject disability	12 months
VAS pain	used to assess the effect of PEMF treatment on reduction of pain	12 months
EQ-5D	used to assess the effect of PEMF treatment on quality of life and economic impact	12 months

Collaborators and Investigators

• Sponsor: Orthofix Inc.
• Investigators: Principal Investigator: James T Ryaby, Ph.D., Orthofix Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 28, 2017
• Primary Completion (ACTUAL): July 12, 2021
• Study Completion (ACTUAL): July 12, 2021

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: June 2, 2017
• First Posted (ACTUAL): June 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 16, 2022
• Last Update Submitted That Met QC Criteria: September 14, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CP-1702SSPM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: if we decide to share, we will only share deidentified summary data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• product manufactured in and exported from the U.S.: No