Spinal Measurement Tool for Spinal Conditions

Overseen By Brett Rocos, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Traumatic injury, Pregnant, Incarcerated, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool used during spine surgeries to help surgeons align the spine to pre-planned positions more accurately. The goal is to determine if this tool leads to better surgical outcomes and fewer follow-up surgeries. It is suitable for individuals scheduled for specific spine surgeries requiring fusion who wish to help test this new technology, the Intraoperative Spinal Measurement System. As an unphased trial, this study allows patients to contribute to innovative surgical advancements and potentially improve their own surgical outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this spinal measurement tool is safe?

Research has shown that systems like the one in this trial are often used during spinal surgeries. They provide surgeons with real-time feedback, which can improve spine alignment and reduce the need for additional surgeries later.

In a study with 30 patients, these systems were tested during surgeries on the lower and middle back. The results indicated that patients tolerated them well, and no major safety issues emerged. Many surgeons use similar systems to lower the risk of nerve problems after surgery.

Overall, evidence suggests that these systems are safe for patients. They assist surgeons in performing more precise operations, leading to better recovery and fewer complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Intraoperative Spinal Measurement System because it offers a novel way to improve surgical precision during spine surgeries. Unlike current methods that rely heavily on visual assessment and existing navigation systems, this tool provides real-time measurements to help surgeons better achieve alignment-related parameters planned before surgery. This system may enhance the accuracy of implant placement, potentially leading to better surgical outcomes and faster recovery times for patients.

What evidence suggests that this spinal measurement system is effective for spinal conditions?

Research has shown that special tools used during spinal surgery, such as the intraoperative spinal measurement system studied in this trial, help surgeons align the spine more accurately. This system provides real-time feedback, enabling surgeons to adjust spinal implant placement during the procedure. Increased precision is expected to improve surgical outcomes and reduce the need for additional surgeries. Early findings suggest that these systems help surgeons achieve their surgical goals more frequently. By improving accuracy, this tool aims to enhance patient safety and accelerate recovery. ^{2 5 6 7 8}

Who Is on the Research Team?

Brett Rocos, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for individuals with various spinal conditions like disc degeneration, spondylosis, and herniated discs. Participants should be undergoing spinal fusion surgery and are willing to have their spine alignment measured intraoperatively.

Inclusion Criteria

I am 18 years or older.

I am scheduled for back surgery that includes spinal fusion and instrumentation.

Exclusion Criteria

I cannot have surgery for my condition.

Incarcerated persons

Any patient current in another trial for a new implant or technique

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo thoracolumbosacral posterior spine surgery using the intraoperative measurement system

1 day

1 visit (in-person)

Postoperative Follow-up

Participants are monitored for outcomes and secondary surgeries with regular follow-up intervals

24 months

Regular visits at 6 weeks, 3 months, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Intraoperative Spinal Measurement System

Trial Overview The study tests a new tool that helps surgeons measure spine alignment during surgery. The goal is to see if using this tool matches pre-surgery plans and improves patient outcomes, potentially reducing the need for more surgeries.

How Is the Trial Designed?

Group I: Thoracolumbosacral posterior spine surgery using intraoperative measurement system Experimental Treatment 1 Intervention

To evaluate the effectiveness of a novel intraoperative spinal measurement tool to assist the surgeon with achieving preoperatively planned alignment-related parameters during surgery. Patients may also be included when the surgeon uses another system or method for placement of the implants (i.e., other navigation system, robot, fluoroscopy, etc.) but also wants to utilize the measurement system. The data will be analyzed as a pool and stratified according to level and # of levels and other demographic and operative data to determine if there are differences.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Proprio Vision, Inc.

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07023393

NCT07023393 | Proprio Spine Measurement Tool This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12293856/

A Systematic Review of Clinical Outcomes and Cost ... Conclusions: IONM significantly improves neurological outcomes in spinal surgery and is cost-effective in most clinical scenarios, particularly ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT07023393

Proprio Spine Measurement Tool - Clinical Trial Finder Study Purpose. This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666548425001970

The future of intraoperative neuromonitoring (IONM) in ... IONM is used during hundreds of thousands of spinal procedures each year to enhance patient safety via real-time neurodiagnostic feedback.

5. propriovision.com propriovision.com/news/proprios-groundbreaking-research-demonstrates-the-potential-for-a-new-standard-of-care-in-surgery-using-volumetric-intelligence-tm

Proprio's Groundbreaking Research Demonstrates the ... This AI technology will enable intraoperative real-time accurate measurements of progress during spine surgery without radiation – an industry first.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560639/

A Prospective Clinical Study to Evaluate Safety and ... The current study provided such data, including outcome data of 30 patients undergoing lumbar and thoracic spinal surgeries with application of ...

7. mdpi.com mdpi.com/2076-3425/15/7/768

A Systematic Review of Clinical Outcomes and Cost ... IONM significantly improves neurological outcomes in spinal surgery and is cost-effective in most clinical scenarios, particularly in high-risk procedures.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4568525/

Intraoperative neurophysiological monitoring in spinal ... Many surgeons have used intraoperative monitoring (IOM) in spinal surgery to reduce the incidence of postoperative neurological complications.