An observational study in Lumbar Spine Degeneration, sponsored by Orthofix Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-16.
Sponsored by Orthofix Inc. · Observational
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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.
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.
Orthofix Inc. is the lead sponsor of 17 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
subjects from all over the United States are eligible for enrollment as long as they meet the inclusion/exclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
one group all of whom will be treated with the PEMF device
Device: SpinalStim
PEMF osteogenesis stimulator
fusion rate
number of subjects with fused lumbar vertebrae, determined by X-rays and CT scans
Time frame: 12 months
Device compliance
actual minutes per day device was used compared with prescribed treatment time
Time frame: 6 months
revision rate
how many subjects had to be reoperated (revised) at the same level(s) during the course of the study
Time frame: 12 months
SF-36
used to assess the effect of PEMF treatment on subject quality of life
Time frame: 12 months
Oswestry Disability Index
used to examine the effect of PEMF treatment on subject disability
Time frame: 12 months
VAS pain
used to assess the effect of PEMF treatment on reduction of pain
Time frame: 12 months
EQ-5D
used to assess the effect of PEMF treatment on quality of life and economic impact
Time frame: 12 months
Plan to share: Undecided — if we decide to share, we will only share deidentified summary data
Ran from Jun 2017 to primary completion in Jul 2021, 48 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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