Proprio Spine Measurement Tool

Duke University

Status: Not yet enrolling

Conditions: Spinal Curvatures; Intervertebral Disc Degeneration; Spondylitis; Spinal Stenosis; Spinal Osteophytosis; Spondylosis; Spinal Osteochondrosis; Intervertebral Disc Displacement

Treatments: Device: Intraoperative spinal measurement system

Study type: Interventional

Funder types: Other

Identifiers

NCT07023393

Pro00118206

Details and patient eligibility

About

This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the patient's spine. The study will also collect outcomes data to determine if achievement of these spinal alignment-related parameters result in satisfactory outcomes and if it reduces the rate of secondary surgeries.

Objectives

Primary: To evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with achieving the surgeon's preplanned alignment-related parameters intraoperatively.

Secondary: To determine if there is a correlation between 1) achievement of preoperative planned alignment-related parameters intraoperatively, and 2) outcomes.

Hypothesis

The application of the intraoperative spinal measurement tool for patients undergoing spinal fusion surgery will improve the surgeon's ability to achieve pre-planned alignment-related parameters intraoperatively and doing so will provide improved outcomes.

Full description

Patient reported outcomes data will be collected on two separate forms- the Oswestry Disability Index (ODI) and the SF-36. The ODI has been widely used since its development in 1980 and has been viewed as effective for measuring disability in daily living associated with low back pain4. The SF-36 is the most used patient reported outcomes measure used both generically as well as specifically for low back pain, and it consists of both a mental as well as physical assessment5. Study data will be compared to historical literature data.

The intraoperative spinal measurement system to be used is the Paradigm TM System by Proprio.

Patients will fill out ODI and SF-36 and will have a postoperative standing long x-ray or EOS at regular follow-up intervals (typically 6w, 3m, 6m, 12m, 24m).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients aged 18 years or older at the time of surgery
• Type of Surgery: Consecutively scheduled patients where the measurement system will be used who will have thoracolumbosacral posterior spine surgery that includes spinal instrumentation and fusion and that consent to the study

Exclusion criteria

• Patients treated for traumatic injury (penetrating injuries, etc.)
• Incarcerated persons
• Pregnant females
• Any patient current in another trial for a new implant or technique
• Non-Spine Related Surgeries: Patients who had surgeries for reasons other than spine-related conditions (even if they incidentally involved the spine)
• Patients having additional surgery occurring concurrently with spine surgery
• Patients ineligible for surgery

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Thoracolumbosacral posterior spine surgery using intraoperative measurement system

Experimental group

Description:

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.

Treatment:

Device: Intraoperative spinal measurement system