Study Using the SpinalStim Device Following Lumbar Fusion Surgery

NCT03176303 | Completed

• 1 other identifier: CP-1702SSPM
• Study Type: observational
• Target: 206
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lumbar Spine Degeneration

Outcome Measures

Primary Outcomes (1)

• fusion rate

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

  12 months

Secondary Outcomes (6)

• Device compliance

  6 months

• revision rate

  12 months

• SF-36

  12 months

• Oswestry Disability Index

  12 months

• VAS pain

  12 months

Study Arms (1)

Pulsed Electromagnetic Field

one group all of whom will be treated with the PEMF device

Device: SpinalStim

Interventions

SpinalStim DEVICE

PEMF osteogenesis stimulator

Pulsed Electromagnetic Field

Eligibility Criteria

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

You may qualify if:

• 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.
• a. 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
• Prior failed fusion at any lumbar level
• Subject reported diabetes
• Subject reported osteoporosis
• Body mass index ≤ 45 kg/m2 at the time of consent.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Orthofix Inc.: lead

Study Sites (1)

ClinTech Center for Spine Health

Johnstown, Colorado, 80534, United States

Location

Related Publications (1)

• 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.

  PMID: 37884337 DERIVED

Study Officials

• James T Ryaby, Ph.D.

  Orthofix Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: June 5, 2017
• Study Start: June 28, 2017
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

US (1)