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ACTIVE NOT RECRUITING
NCT05633550

Flexion-Extension Radiograph Imaging Protocol Reliability Study

Sponsor: Rijnstate Hospital

View on ClinicalTrials.gov

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.

Official title: Evaluating the Test-retest Reliability of a Standardized Flexion - Extension Radiograph Imaging Protocol for the Lumbar Spine.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

45

Start Date

2024-11-27

Completion Date

2026-07-01

Last Updated

2025-09-11

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Flexion-extension radiographs

Participants will undergo (regular) flexion-extension radiographs.

Locations (2)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

OLVG

Amsterdam, Netherlands