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Intervertebral Disc DegenerationNCT07023393

Proprio Spine Measurement Tool

A study testing Intraoperative spinal measurement system in people with Intervertebral Disc Degeneration and Intervertebral Disc Displacement, run by Duke University at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Intraoperative spinal measurement system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
20 Apr 2026to 20 Apr 2029
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Duke University Health System

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Effectiveness of an Intraoperative Spine Measurement Tool and Outcomes Assessment From Its Use in Spinal Fusion Surgery

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

Read more

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.

Read the 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).

Being tested
Intraoperative spinal measurement system
Keywords
Spine surgery, Proprio, Spine Measurement, Adults, Posterior Spine Surgery, Spine Fusion, Thoracic Spine Surgery, Lumbar Spine Surgery, Sacral Spine Surgery
Medical subject headings
Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Osteochondrosis, Spinal Osteophytosis, Spinal Stenosis, Spondylitis, Spondylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intraoperative spinal measurement systemDevice

    Also called Paradigm TM System by Proprio

    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.

Study groups in NCT07023393
Study groupRoleWhat they receive
Thoracolumbosacral posterior spine surgery using intraoperative measurement systemExperimentalTo 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.
Receives: Device: Intraoperative spinal measurement system

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (3)

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

    The Oswestry Disability Index (ODI) measures disability in daily living associated with low back pain. The total score is calculated as a percentage, with 0% indicating no disability and 100% indicating the highest level of disability.

    Measured: Enrollment to 24 months post-operatively

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

    The SF-36 measures health-related quality of life across eight domains, each scored 0-100 (higher = better health). Two summary scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived.

    Measured: Enrollment to 24 months post-operatively

  3. Number of secondary surgeries

    Number of secondary surgeries will be collected through the electronic health record and from the patient to capture any surgery performed outside Duke.

    Measured: Enrollment to 24 months post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start20 Apr 2026 (estimated)
  3. Primary completion20 Apr 2027 (estimated)
  4. Study completion20 Apr 2029 (estimated)

Why it stopped: Budgeting Concerns

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07023393
Sponsor's protocol ID
Pro00118206
Status last verified
Apr 2026
First submitted
10 Jun 2025
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 31370009

  • 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.

    PubMed 36777909

  • 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.

    PubMed 34166276

  • 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.

    PubMed 23773433

  • 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.

    PubMed 17043282

Questions about this trial

What is this clinical trial studying?

A study testing Intraoperative spinal measurement system in people with Intervertebral Disc Degeneration and Intervertebral Disc Displacement, run by Duke University at 1 site 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of times the adjustment tool failed to represent the POF within a margin of 3 degrees (time frame: Pre-operative planned state (enrollment), Postoperative final state (12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07023393, which also lists 5 linked publications.

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 23 Apr 2026.

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