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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05633550
Other study ID # NL82684.091.22
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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)

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

Auerbach JD, Namdari S, Milby AH, White AP, Reddy SC, Lonner BS, Balderston RA. The parallax effect in the evaluation of range of motion in lumbar total disc replacement. SAS J. 2008 Dec 1;2(4):184-8. doi: 10.1016/SASJ-2008-0020-RR. eCollection 2008. — View Citation

Bogduk, N., Instability, in Clinical and Radiological Anatomy of the Lumbar Spine, N. Bogduk, Editor. 2012, Elsevier Health Sciences. p. 207-216

Bolus NE. NCRP report 160 and what it means for medical imaging and nuclear medicine. J Nucl Med Technol. 2013 Dec;41(4):255-60. doi: 10.2967/jnmt.113.128728. Epub 2013 Oct 31. Erratum In: J Nucl Med Technol. 2014 Jun;42(2):160. — View Citation

Cardis E, Vrijheid M, Blettner M, Gilbert E, Hakama M, Hill C, Howe G, Kaldor J, Muirhead CR, Schubauer-Berigan M, Yoshimura T, Bermann F, Cowper G, Fix J, Hacker C, Heinmiller B, Marshall M, Thierry-Chef I, Utterback D, Ahn YO, Amoros E, Ashmore P, Auvinen A, Bae JM, Solano JB, Biau A, Combalot E, Deboodt P, Diez Sacristan A, Eklof M, Engels H, Engholm G, Gulis G, Habib R, Holan K, Hyvonen H, Kerekes A, Kurtinaitis J, Malker H, Martuzzi M, Mastauskas A, Monnet A, Moser M, Pearce MS, Richardson DB, Rodriguez-Artalejo F, Rogel A, Tardy H, Telle-Lamberton M, Turai I, Usel M, Veress K. Risk of cancer after low doses of ionising radiation: retrospective cohort study in 15 countries. BMJ. 2005 Jul 9;331(7508):77. doi: 10.1136/bmj.38499.599861.E0. Epub 2005 Jun 29. — View Citation

Environment, E.C.D.-G.f., Guidance on medical exposures in medical and biomedical research. 1999, European Commission Publications Office.

Hasegawa K, Shimoda H, Kitahara K, Sasaki K, Homma T. What are the reliable radiological indicators of lumbar segmental instability? J Bone Joint Surg Br. 2011 May;93(5):650-7. doi: 10.1302/0301-620X.93B5.25520. — View Citation

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. — View Citation

Hipp JA, Guyer RD, Zigler JE, Ohnmeiss DD, Wharton ND. Development of a novel radiographic measure of lumbar instability and validation using the facet fluid sign. Int J Spine Surg. 2015 Jul 17;9:37. doi: 10.14444/2037. eCollection 2015. — View Citation

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.

Patwardhan AG, Havey RM, Wharton ND, Tsitsopoulos PP, Newman P, Carandang G, Voronov LI. Asymmetric motion distribution between components of a mobile-core lumbar disc prosthesis: an explanation of unequal wear distribution in explanted CHARITE polyethylene cores. J Bone Joint Surg Am. 2012 May 2;94(9):846-54. doi: 10.2106/JBJS.J.00638. — View Citation

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. — View Citation

Staub BN, Holman PJ, Reitman CA, Hipp J. Sagittal plane lumbar intervertebral motion during seated flexion-extension radiographs of 658 asymptomatic nondegenerated levels. J Neurosurg Spine. 2015 Dec;23(6):731-8. doi: 10.3171/2015.3.SPINE14898. Epub 2015 Aug 21. — View Citation

Transport, E.C.D.-G.f.E.a., European guidance on estimating population doses from medical x-ray procedures. 2008.

Weiler PJ, King GJ, Gertzbein SD. Analysis of sagittal plane instability of the lumbar spine in vivo. Spine (Phila Pa 1976). 1990 Dec;15(12):1300-6. doi: 10.1097/00007632-199012000-00012. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 18 references in allClick 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
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