KyphosisLOADPRONCT02768675
Intra-operative Assessment of the Intellirod LOADPRO Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
A study testing LOADPRO in people with Kyphosis and Spinal Fractures, run by Intellirod Spine at 2 sites in United States.
Trial summary
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kyphosis, Spinal Fractures
- What is being tested?
- LOADPRO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2016to Dec 2018
- Phase
- Interventional
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 18 and 65 years of age
- presenting with a confirmed diagnosis of kyphosis with deformity greater than 70 degrees requiring large segmental correction involving a minimum of six (6) levels
- failure of conservative therapy requiring surgical correction of sagittal imbalance
- sagittal imbalance due to loss of lumbar lordosis, and/or segmental kyphosis
- participated in the informed consent process and has signed an Institutional Review Board approved informed consent
Who cannot join
- women who are pregnant
- evidence of active (systemic or local) infection at time of surgery
- prisoner or transient
- history of known narcotic abuse
- psychological disturbance past or present that could impair the consent process or ability to complete subject self-report questionnaires
- ASA > 3
- osteoporosis diagnosed on DEXA defined as a T-score ≥ -2.0
- Unable or unwilling to provide a full informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
OhioHealth Neurological Physicians
Columbus, Ohio, 43215
Chris S Karas, MD, 614-566-9777, Chris.Karas@ohiohealth.com
Chris S Karas, MD
- Recruiting
Norton Leatherman Spine Center
Louisville, Kentucky, 40202
Jeffrey L Gum, MD, 502-584-7525, jlgum001@gmail.com
Jeffrey L Gum, MD
About this study
Official title: Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
Read the detailed description
The Intellirod LOADPRO™ sensor is an intra-operative titanium and ceramic, single use, disposable, strain sensing device, which includes hermetically sealed, micro electromechanical systems (MEMS) and radio-frequency identification (RFID) technology to enable measurement of intra-operative rod strain values. The transponder attaches to any commercially available 5.5mm diameter CoCr or Ti Alloy rod commonly used for posterior pedicle fixation systems. The transponder is used only to acquire rod strain values and a unique device identification code, which is obtained by a hand-held reader, providing real-time, objective measurement of the mechanical rod strain.
This non-significant risk case series is intended to assess the effectiveness of the Intellirod LOADPRO™ sensor methodology and the intra-operative measurement of spinal rod strain. The LOADPRO™ sensors will be removed from the spinal rods after obtaining load measurements.
- Conditions
- Kyphosis, Spinal Fractures
- Being tested
- LOADPRO
- Keywords
- Kyphotic, Corrective Surgery, Spinal fractures
- Medical subject headings
- Kyphosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LOADPRODevice
The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain.
| Study group | Role | What they receive |
|---|---|---|
| LOADPRO arm | Experimental | Participants will temporarily receive a LOADPRO device affixed to kyphotic corrective rods. The device will not be implanted and will be removed prior to surgery closure. Receives: Device: LOADPRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bilateral Rod Strain Readings
In this research study, the LOADPRO device will be used solely to monitor and record rod strain readings. The device is not intended, and won't be used, to control or make any rod adjustments by the operative surgeon. In order to provide assurance that the readings cannot be used to make adjustments intra-operatively, the surgeon investigators will be blinded to the rod strain measurement readings.
Measured: Intra-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2016 (estimated)
- Study startMay 2016
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KyphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intellirod Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard N Navarro, Study director, Intellirod Spine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02768675
- Sponsor's protocol ID
- LOADPRO EX-0029
- Acronym
- LOADPRO
- Status last verified
- Aug 2017
- First submitted
- 5 May 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Operative Assessment of the Intellirod LOADPRO Disposable Spinal Rod Strain Sensor for Use During Kyphotic Corrective Surgery
- ClinicalTrials.gov ID
- NCT02768675
- Acronym / sponsor ID
- LOADPRO / LOADPRO EX-0029
- Conditions
- Kyphosis, Spinal Fractures
- Keywords
- Kyphotic, Corrective Surgery, Spinal fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Intellirod SpineIndustry (pharma, biotech, devices)
- Study start
- May 2016
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 11 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The LOADPRO Study is an intra-operative, non-significant risk (NSR) case series feasibility assessment of the Intellirod LOADPRO™ System measuring spinal rod strain in long spinal kyphotic corrective constructs.
Detailed description
The Intellirod LOADPRO™ sensor is an intra-operative titanium and ceramic, single use, disposable, strain sensing device, which includes hermetically sealed, micro electromechanical systems (MEMS) and radio-frequency identification (RFID) technology to enable measurement of intra-operative rod strain values. The transponder attaches to any commercially available 5.5mm diameter CoCr or Ti Alloy rod commonly used for posterior pedicle fixation systems. The transponder is used only to acquire rod strain values and a unique device identification code, which is obtained by a hand-held reader, providing real-time, objective measurement of the mechanical rod strain.
This non-significant risk case series is intended to assess the effectiveness of the Intellirod LOADPRO™ sensor methodology and the intra-operative measurement of spinal rod strain. The LOADPRO™ sensors will be removed from the spinal rods after obtaining load measurements.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LOADPRO arm | Experimental | Device: LOADPROParticipants will temporarily receive a LOADPRO device affixed to kyphotic corrective rods. The device will not be implanted and will be removed prior to surgery closure. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between 18 and 65 years of age
- presenting with a confirmed diagnosis of kyphosis with deformity greater than 70 degrees requiring large segmental correction involving a minimum of six (6) levels
- failure of conservative therapy requiring surgical correction of sagittal imbalance
- sagittal imbalance due to loss of lumbar lordosis, and/or segmental kyphosis
- participated in the informed consent process and has signed an Institutional Review Board approved informed consent
Key exclusion criteria (8 listed)
- women who are pregnant
- evidence of active (systemic or local) infection at time of surgery
- prisoner or transient
- history of known narcotic abuse
- psychological disturbance past or present that could impair the consent process or ability to complete subject self-report questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LOADPROThe Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain. | Device | LOADPRO arm |
Primary outcome
Bilateral Rod Strain Readings
Time frame: Intra-operative
In this research study, the LOADPRO device will be used solely to monitor and record rod strain readings. The device is not intended, and won't be used, to control or make any rod adjustments by the operative surgeon. In order to provide assurance that the readings cannot be used to make adjustments intra-operatively, the surgeon investigators will be blinded to the rod strain measurement readings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard N Navarro study director
Intellirod Spine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LOADPRO in people with Kyphosis and Spinal Fractures, run by Intellirod Spine at 2 sites 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Richard N Navarro (234-678-8965, rnavarro@intellirodspine.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bilateral Rod Strain Readings (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2017.