Flexion-Extension Radiograph Imaging Protocol Reliability Study

NCT05633550 | Active Not Recruiting

• 1 other identifier: NL82684.091.22
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

Orthopedic surgeons often face the dilemma of whether to add fusion to a decompression procedure of the spine. Their decision mainly relies on personal experience to determine if a level is unstable preoperatively or if a specific decompression procedure might destabilize the spine. Lumbar spine flexion-extension radiographs aim to provide clinicians with images to assess the dynamism of a vertebral level, which crucial for evaluating spinal instability. However, the lack of a standardized imaging protocol for taking such flexion-extension radiographs leads to wide variability in their quality. This impacts the efficacy of radiographic measurements of angular and translational motion used for diagnosis. To effectively and reliably diagnose instability, it is crucial to control and standardize the flexion-extension radiograph protocols to promote the repeatability of intervertebral motion that characterizes a patient's full range of motion. The objective of this study is to evaluate the test-retest reliability of a standardized flexion - extension radiograph imaging protocol for the lumbar spine. This is an exploratory reliability study. A non-probability purposive sample of 45 patients with back pain from two tertiary care hospitals in The Netherlands is used. There is bo intervention. The main study parameter/endpoint is the agreement between the participants' first ("test") and second ("retest") kinematic results from their lumbar flexion-extension radiographs.

Conditions

Lumbar Spinal Stenosis; Spinal Instability

Keywords

Diagnostic Imaging; Decision Support Systems, Clinical; Radiographic Image Interpretation, Computer-Assisted; Surgical Decompression

Outcome Measures

Primary Outcomes (1)

• Agreement between the participants' first ("test") and second ("retest") kinematic results: intervertebral translation, intervertebral rotation and a value derived form the latter: translation-per-degree-of-rotation.

  Test-retest reliability.

  One hour after taking both sets of the flexion-extension radiographs

Interventions

Flexion-extension radiographs DIAGNOSTIC_TEST

Participants will undergo (regular) flexion-extension radiographs.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A non-probability purposive sample of 45 patients will be recruited.

You may qualify if:

• referral to the orthopaedic surgeon because of pain in the back or leg and requiring lumbar spine radiographs so the orthopaedic surgeon is able to diagnose the probable cause of the pain.
• over the age of 18 years
• ability to flex and extend the spine sufficiently to facilitate acceptable flexion and extension radiographs.

You may not qualify if:

• any form of spine-related traumatic injury
• prior lumbar spinal surgery
• lateral spondylolisthesis or coronal plane curvature in the lumbar spine of \>10°
• the presence of involuntary back muscle spasms
• the presence of significant changes in pain during the day
• inability to understand and sign the study Informed Consent form
• inability to follow oral instructions

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (2)

Rijnstate Hospital

Arnhem, Gelderland, 6800 WC, Netherlands

Location

OLVG

Amsterdam, Netherlands

Location

Related Publications (18)

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  PMID: 26273555 BACKGROUND

• Zhao K, Yang C, Zhao C, An KN. Assessment of non-invasive intervertebral motion measurements in the lumbar spine. J Biomech. 2005 Sep;38(9):1943-6. doi: 10.1016/j.jbiomech.2004.07.029.

  PMID: 16023484 BACKGROUND

• Pearson AM, Spratt KF, Genuario J, McGough W, Kosman K, Lurie J, Sengupta DK. Precision of lumbar intervertebral measurements: does a computer-assisted technique improve reliability? Spine (Phila Pa 1976). 2011 Apr 1;36(7):572-80. doi: 10.1097/BRS.0b013e3181e11c13.

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  PMID: 25802620 BACKGROUND

• Zhao KD, Ben-Abraham EI, Magnuson DJ, Camp JJ, Berglund LJ, An KN, Bronfort G, Gay RE. Effect of Off-Axis Fluoroscopy Imaging on Two-Dimensional Kinematics in the Lumbar Spine: A Dynamic In Vitro Validation Study. J Biomech Eng. 2016 May;138(5):054502. doi: 10.1115/1.4032995.

  PMID: 26974192 BACKGROUND

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  PMID: 26296193 BACKGROUND

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• Hipp JA, Chan EF. Threshold Limit Graphical Approach to Understanding Outcome Predictive Metrics: Data from the Osteoarthritis Initiative. Cureus. 2017 Jul 8;9(7):e1447. doi: 10.7759/cureus.1447.

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• (NFU), N.F.v.U.M.C., Richtlijn Kwaliteitsborging Mensgebonden Onderzoek. 2020, Nederlandse Federatie van Universitair Medische Centra (NFU)

  BACKGROUND

• JA, H., et al., A new method correlating an objective radiographic metric for lumbar spine instability and the facet fluid sign on MRI, in International Society of the Advancement of Spine Surgery. 2015: San Diego.

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  BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Job LC van Susante, Dr. PhD.

  Department of orthopedics, Rijnstate Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: December 1, 2022
• Study Start: November 27, 2024
• Primary Completion: August 25, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

NL (2)