Lumbar Spinal Stenosis Clinical Trial
Official title:
Evaluating the Validity and Test-retest Reliability of the Sagittal Plane Shear Index (SPSI).
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').
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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Rijnstate Hospital | Arnhem | Gelderland |
Lead Sponsor | Collaborator |
---|---|
Rijnstate Hospital | Medical Metrics Diagnostics, Inc |
Netherlands,
(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 all — Click here to view all references
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04795284 -
Biomechanical Parameters of Gait in Patients With Symptomatic Lumbar Spinal Stenosis and Healthy Elderly.
|
||
Recruiting |
NCT04066296 -
Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
|
Phase 2 | |
Active, not recruiting |
NCT05114135 -
TLIF Osteo3 ZP Putty Study (Also Known as the TOP Fusion Study)
|
N/A | |
Recruiting |
NCT06057428 -
Activity Levels Amongst Patients With Lumbar Spinal Stenosis
|
||
Recruiting |
NCT06075862 -
Balance Amongst Patients With Lumbar Spinal Stenosis
|
||
Recruiting |
NCT05527145 -
Spinal Stenosis and Listhesis Treated With Percutaneous Interspinous Spacer: a Non-surgical Trial
|
N/A | |
Recruiting |
NCT01902979 -
The Spinal Stenosis Pedometer and Nutrition e-Health Lifestyle Intervention (SSPANLI) Trial
|
N/A | |
Completed |
NCT00749073 -
The Vertos MILD™ Preliminary Patient Evaluation Study
|
N/A | |
Completed |
NCT00527527 -
Chiropractic Dosage for Lumbar Stenosis
|
Phase 2 | |
Completed |
NCT00405691 -
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
|
Phase 3 | |
Completed |
NCT03194607 -
Quantitative Evaluation of Motor Function Before and After Surgery for Degenerative Lumbar Spinal Stenosis
|
||
Recruiting |
NCT06034405 -
Analysis of Lumbar Spine Stenosis Specimens for Identification of Transthyretin Cardiac Amyloidosis
|
||
Completed |
NCT06079580 -
Patients With Lumbar Spinal Stenosis With Balance Disorder
|
||
Recruiting |
NCT05523388 -
Role of Spinal Load in the Pathophysiology of Lumbar Spinal Stenosis
|
||
Completed |
NCT04587401 -
The Effects of Anesthesia on Cerebral Perfusion in Patients With High Blood Pressure
|
N/A | |
Completed |
NCT04563793 -
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
|
||
Suspended |
NCT03381677 -
Pedicle Osteotomy for Stenosis Trial
|
N/A | |
Completed |
NCT02258672 -
Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis
|
N/A | |
Completed |
NCT02260401 -
Long Term Outcomes of Lumbar Epidural Steroid Injections for Spinal Stenosis
|
N/A | |
Completed |
NCT01994512 -
Swedish Spinal Stenosis Study
|
N/A |