SPSI Validity and Test-Retest Reliability Study

Lumbar Spinal Stenosis Clinical Trial

Official title:

Evaluating the Validity and Test-retest Reliability of the Sagittal Plane Shear Index (SPSI).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05633550
• Other study ID #: NL82684.091.22
• Status: Not yet recruiting
• Start date: August 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Rijnstate Hospital
• Contact: Joey FH Reijmer, Drs.
• Phone: 088 - 005 7744
• Email: jreijmer[@]rijnstate.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Orthopaedic surgeons are often faced with the clinical dilemma of whether or not to add fusion to a decompression procedure. To decide between these two surgical options, surgeons rely mostly on their experience to conclude if a level is unstable preoperatively or if a specific decompression procedure is likely to destabilize the spine. Recently, the Sagittal Plain Shear Index (SPSI) has been developed as a valid test for determining the degree of spinal (in)stability. The SPSI metric, which can be calculated using flexion-extension radiographs of the lumbar spine, informs the orthopaedic surgeon about whether the spine is stable in and of itself (necessitating decompression surgery only) or whether there is spinal instability (necessitating decompression and additional fusion surgery). The SPSI metric can be calculated using both the validated semi-automated QMA® and more recently developed fully automated Spine CAMP software platforms. The concurrent validity between these two software platforms, as well as the reliability of both of these objective diagnostic indicator for spinal instability have not yet been evaluated. This study will investigate if SPSI-metrics/values obtained with Spine CAMP are equivalent to measurements from QMA®, and will also investigate the repeatability of two measurements of the SPSI taken one hour apart ('test-retest reliability').

Description:

Lumbar spinal stenosis is a relatively common medical problem, but optimal treatment for the condition is poorly understood. Lumbar spinal stenosis is commonly treated with decompression surgery with or without additional fusion surgery. Orthopaedic surgeons are currently faced with the dilemma of whether or not to add fusion to a decompression procedure. To decide between these two surgical options, surgeons rely mostly on their experience to conclude if a level is unstable preoperatively or if a specific decompression procedure is likely to destabilize the spine. A valid and reliable test for spinal instability would facilitate research to determine whether spinal instability measurements can be used to choose the optimal surgical treatment for each level. Recently, an objective metric called the Sagittal Plane Shear Index (SPSI) has been developed and described in the scientific literature. SPSI quantifies the magnitude of sagittal plane translation-per-degree-of-rotation (TPDR) of the posterior-inferior corner of a vertebra in a direction defined by the superior endplate of the immediately inferior vertebra. The TPDR calculations are based on flexion-extension radiographs: one (flexion) radiograph during which a patient bends forward, and one (extension) radiograph during which a patient bends backwards. The TPDR is reported as the number of standard deviations from the average found at radiographically normal levels in asymptomatic volunteers. The resulting SPSI metric informs the orthopaedic surgeon about whether the spine is stable in and of itself (necessitating decompression surgery only) or whether there is spinal instability (necessitating decompression and additional fusion surgery). Because additional fusion procedures can add substantial expense and morbidity to the surgery, it is important to avoid fusion when possible. As such, knowledge about spinal (in)stability is critical for selecting the most appropriate surgical procedure for treatment of lumbar spinal stenosis. The SPSI metric can be obtained in routine clinical practice using translation and rotation measurements obtained with a validated computer-assisted method named Quantitative Motion Analysis (QMA®). Recently, a fully automated version of this method (Spine CAMP) has been developed, which provides the same SPSI metric analysis using neural networks and coded logic without any human intervention. SPSI metric values > 2 informs a clinician that the TPDR is > 2 standard deviations above the average TPDR in the radiographically normal, asymptomatic population. This provides for an objective diagnostic indicator for spinal instability defined as a specific, well-defined intervertebral motion metric that is outside the 95% confidence interval established for radiographically normal, asymptomatic volunteers. If SPSI is > 2 at a level where surgical treatment for stenosis is planned, then the clinician has objective evidence of abnormal motion and this may help to determine whether fusion should be added to the decompression surgery and what type of fusion surgery should be performed. SPSI is intended only to help with treatment planning and the clinician is required to interpret the metric in context of all other relevant clinical factors. The QMA® method has previously been validated to have the accuracy and reproducibility required for measuring the small translations that occur in a healthy spine. Spine CAMP has been documented to provide rotation and translation measurements equivalent to QMA®. A clinical investigation is also currently underway in The Netherlands to test the potential clinical efficacy of the SPSI in diagnosing abnormal motion, in order to use this diagnosis in the decision process on whether to add fusion to decompression of a stenotic lumbar level. However, evidence supporting the repeatability of SPSI measurements, and equivalence of SPSI from Spine CAMP versus QMA®, is lacking and therefore needed.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Lumbar Spinal Stenosis
• Spinal Instability
• Spinal Stenosis

Intervention

Diagnostic Test:
• Flexion-extension radiographs
Participants will undergo (regular) flexion-extension radiographs.

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Rijnstate Hospital	Medical Metrics Diagnostics, Inc

Country where clinical trial is conducted

Netherlands, 

References & Publications (18)

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Hipp, J., P. Newman, and O. Avila-Montes. Toward standardization of lumbar flexion-extension studies. in ISASS. 2018. Toronto

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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* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systematic differences between the participants' Sagittal Plane Shear Index values obtained with the QMA® and Spine CAMP software methods.	Concurrent validity between the two software methods.	One hour after taking both sets of the flexion-extension radiographs
Primary	Repeatability of the measurements of the participants' Sagittal Plane Shear Index values obtained with both the QMA® and Spine CAMP software methods.	Test-retest reliability of the two software methods.	One hour after taking both sets of the flexion-extension radiographs