NCT07023393

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.

Trial Health

50
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
36mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

June 10, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
10 months until next milestone

Study Start

First participant enrolled

April 20, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2027

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2029

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

June 10, 2025

Last Update Submit

April 20, 2026

Conditions

Intervertebral Disc DegenerationIntervertebral Disc DisplacementSpinal CurvaturesSpinal OsteochondrosisSpinal OsteophytosisSpinal StenosisSpondylitisSpondylosis

Keywords

Spine surgeryProprioSpine MeasurementAdultsPosterior Spine SurgerySpine FusionThoracic Spine SurgeryLumbar Spine SurgerySacral Spine Surgery

Outcome Measures

Primary Outcomes (1)

  • Number of times the adjustment tool failed to represent the POF within a margin of 3 degrees

    Effectiveness of the intraoperative spinal measurement tool will be assessed

    Pre-operative planned state (enrollment), Postoperative final state (12 months)

Secondary Outcomes (3)

  • Patient Reported Outcomes as measured by the Oswestry Disability Index (ODI)

    Enrollment to 24 months post-operatively

  • Patient Reported Outcomes as measured by the 36-Item Short Form Survey (SF-36)

    Enrollment to 24 months post-operatively

  • Number of secondary surgeries

    Enrollment to 24 months post-operatively

Study Arms (1)

Thoracolumbosacral posterior spine surgery using intraoperative measurement system

EXPERIMENTAL

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.

Device: Intraoperative spinal measurement system

Interventions

Intraoperative spinal measurement systemDEVICE

The design is a prospective study to evaluate the effectiveness of a novel intraoperative spinal measurement tool to assist the surgeon with achieving preoperatively planned alignment-related parameters during surgery.

Also known as: Paradigm TM System by Proprio
Thoracolumbosacral posterior spine surgery using intraoperative measurement system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

  • 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.

    PMID: 31370009BACKGROUND

  • 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.

    PMID: 36777909BACKGROUND

  • 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.

    PMID: 34166276BACKGROUND

  • 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.

    PMID: 23773433BACKGROUND

  • 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.

    PMID: 17043282BACKGROUND

MeSH Terms

Conditions

Intervertebral Disc DegenerationIntervertebral Disc DisplacementSpinal CurvaturesSpinal OsteochondrosisSpinal OsteophytosisSpinal StenosisSpondylitisSpondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsOsteochondrosisBone Diseases, InfectiousInfections

Study Officials

  • Brett Rocos, MD

    Duke University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 17, 2025

Study Start

April 20, 2026

Primary Completion (Estimated)

April 20, 2027

Study Completion (Estimated)

April 20, 2029

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)