Clinical trial NCT07023393: Proprio Spine Measurement Tool
Official title: Effectiveness of an Intraoperative Spine Measurement Tool and Outcomes Assessment From Its Use in Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Spinal Curvatures
Spinal Osteochondrosis
Spinal Osteophytosis
Spinal Stenosis
Spondylitis
Spondylosis
Keywords: Spine surgery
Proprio
Spine Measurement
Adults
Posterior Spine Surgery
Spine Fusion
Thoracic Spine Surgery
Lumbar Spine Surgery
Sacral Spine Surgery
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Proprio Vision, Inc.
First posted: 2025-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of times the adjustment tool failed to represent the POF within a margin of 3 degrees
timeFrame: Pre-operative planned state (enrollment), Postoperative final state (12 months)
Secondary outcomes:
measure: Patient Reported Outcomes as measured by the Oswestry Disability Index (ODI)
timeFrame: Enrollment to 24 months post-operatively
measure: Patient Reported Outcomes as measured by the 36-Item Short Form Survey (SF-36)
timeFrame: Enrollment to 24 months post-operatively
measure: Number of secondary surgeries
timeFrame: Enrollment to 24 months post-operatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke University
name: Brett Rocos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Finkelstein JA, Schwartz CE. Patient-reported outcomes in spine surgery: past, current, and future directions. J Neurosurg Spine. 2019 Aug 1;31(2):155-164. doi: 10.3171/2019.1.SPINE18770. Epub 2019 Aug 1.
citation: Beighley A, Zhang A, Huang B, Carr C, Mathkour M, Werner C, Scullen T, Kilgore MD, Maulucci CM, Dallapiazza RF, Kalyvas J. Patient-reported outcome measures in spine surgery: A systematic review. J Craniovertebr Junction Spine. 2022 Oct-Dec;13(4):378-389. doi: 10.4103/jcvjs.jcvjs_101_22. Epub 2022 Dec 7.
citation: Lau KKL, Samartzis D, To NSC, Harada GK, An HS, Wong AYL. Demographic, Surgical, and Radiographic Risk Factors for Symptomatic Adjacent Segment Disease After Lumbar Fusion: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. 2021 Aug 4;103(15):1438-1450. doi: 10.2106/JBJS.20.00408.
citation: Radcliff KE, Kepler CK, Jakoi A, Sidhu GS, Rihn J, Vaccaro AR, Albert TJ, Hilibrand AS. Adjacent segment disease in the lumbar spine following different treatment interventions. Spine J. 2013 Oct;13(10):1339-49. doi: 10.1016/j.spinee.2013.03.020. Epub 2013 Jun 15.
citation: Ikard RW. Methods and complications of anterior exposure of the thoracic and lumbar spine. Arch Surg. 2006 Oct;141(10):1025-34. doi: 10.1001/archsurg.141.10.1025.