NCT03177473

Brief Summary

This study examines the effect of adjunctive use of the CervicalStim bone growth stimulator on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery. All participants will wear the bone growth stimulator every day for 4 hours/day for 6 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
211

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
22 days until next milestone

Study Start

First participant enrolled

June 28, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2021

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

4.1 years

First QC Date

April 27, 2017

Last Update Submit

September 14, 2022

Conditions

Vertebral Cervical Fusion SyndromeDegenerative Disc Disease

Keywords

degenerative disc diseaseCervicalStim deviccervicalcervical fusion

Outcome Measures

Primary Outcomes (1)

  • cervical fusion rate

    fusion rate assessed via radiographic confirmation (Xray and CT)

    12 months

Secondary Outcomes (6)

  • Device Compliance

    6 months

  • revision rate

    12 months

  • SF-36

    12 months

  • Neck Disability Index (NDI)

    12 months

  • EQ-5D

    12 months

  • +1 more secondary outcomes

Study Arms (1)

CervicalStim PEMF group

all subjects will receive active CervicalStim bone growth stimulator

Device: CervicalStim bone growth stimulator

Interventions

CervicalStim bone growth stimulatorDEVICE

Orthofix CervicalStim bone growth stimulator

CervicalStim PEMF group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects from all over the United States will be 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 cervical fusion surgery within 30 days of Informed Consent signing.
  • a. Surgical approach is at the physician's discretion.
  • Subject has one or more high risk factors:
  • Is currently using nicotine
  • multi-level cervical fusion surgery planned
  • Prior failed fusion at any cervical 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 v.9.3 or later).
  • 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 Informed Consent Form (ICF).

You may not qualify if:

  • Current alcoholism and/or any known current addiction to pain medications.
  • 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.
  • Subject is a prisoner.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ClinTech Center for Spine Health

Johnstown, Colorado, 80534, United States

Location

MeSH Terms

Conditions

Klippel-Feil SyndromeIntervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

DysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSpinal Diseases

Study Officials

  • James T Ryaby, PhD

    Orthofix Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2017

First Posted

June 6, 2017

Study Start

June 28, 2017

Primary Completion

August 3, 2021

Study Completion

August 3, 2021

Last Updated

September 16, 2022

Record last verified: 2022-09

Locations

US(1)