Lumbar Spinal StenosisNCT05633550
Flexion-Extension Radiograph Imaging Protocol Reliability Study
An observational study of Lumbar Spinal Stenosis and Spinal Instability, run by Rijnstate Hospital at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spinal Stenosis, Spinal Instability
- What is being tested?
- Flexion-extension radiographs
- How many people
- 50 participants
- Where
- 2 sitesNetherlands
- Study dates
- 27 Nov 2024to 1 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A non-probability purposive sample of 45 patients will be recruited.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
OLVG
Amsterdam
Rijnstate Hospital
Arnhem, Gelderland, 6800 WC
About this study
Official title: Evaluating the Test-retest Reliability of a Standardized Flexion - Extension Radiograph Imaging Protocol for the Lumbar Spine.
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.
Read the detailed description
Lumbar spinal stenosis, a narrowing of the spinal canal in the lower part of the back, is a relatively common medical problem, but optimal treatment for the condition is poorly understood. Lumbar spinal stenosis is commonly treated with decompression surgery (providing more space for the compressed nerve roots) with or without additional lumbar fusion surgery (connecting two or more vertebrae to eliminate instability). 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 personal experience. They have to subjectively gauge whether 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.
A reliable diagnostic assessment for spinal instability would ideally be validated using an existing "gold standard" test. Such a test should have a very high sensitivity and specificity and must be supported by clearly developed rationale and high-quality evidence. Unfortunately, such a test does not currently exist for spinal instability. However, abnormalities in intervertebral motion are often a hallmark for spinal instability. A commonly accepted way to examine intervertebral motion is by analyzing the patient's flexion-extension radiographs. Using these two radiographs, the spine's sagittal plane intervertebral motion can be measured. The relative motion between the two images can be measured at all relevant levels either through manual measurement or computer assisted methods. Ideally, a standardized flexion-extension radiograph imaging protocol accomplishes the following: the patient sufficiently stresses the spine in order to assess the integrity of intervertebral motion restraints (ligaments, annulus, facet capsule, etc.), it is easily implemented into the clinical work flow, and it is reliable and repeatable across subjects and clinicians.
A myriad of patient positioning protocols for the flexion-extension radiograph imaging procedure have been tested and deployed, although generally without well-validated success criteria. Despite the large amount of studies on the topic, no one flexion-extension radiograph imaging protocol has been widely accepted. This suggests that 1) the studies were not appropriately powered to influence change, 2) some protocols (methods, equipment, instructions, etc.) are not easily implemented or practical in routine clinical workflows, 3) acquiring radiograph images of the lumbar spine in sufficiently stressed positions is not widely accepted as clinically important, or 4) most ordering clinicians do not realize how often a patient fails to adequately stress the spine while undergoing a standard of care flexion-extension radiograph. One factor that can often cast doubt on the efficacy of the flexion-extension radiograph procedure is the level of patient effort or range of spinal motion achieved by the patient. For standing flexion-extension radiographs, more patient effort leads to more intervertebral motion. This is a fairly simple and intuitive concept. However, achieving maximum patient effort is not a simple task. It could be argued that symptomatic patients should not be expected to exert maximum effort because it can be painful or uncomfortable. This argument can be supplemented with evidence that fear avoidance can limit motion and intervertertebral motion is substantially increased after analgesic injections.
Despite some of the arguments that can be used against the implementation of standardized flexion-extension radiograph imaging protocols in assessing spinal instability, there is ample data that good patient effort can be obtained in symptomatic patients. In one large multi-site study of lumbar stenosis with the exact same patient inclusion/exclusion criteria, a large amount of variance can be seen in the average level of intervertebral rotation. This suggests that differences in the flexion-extension radiograph protocol could be the driving factor in this high amount of variance seen between sites. It is also possible that the physician and/or radiology technician helped to quell patient's fear of motion by explaining that the maximum flexion and extension will not injure their back and will provide the best data for a reliable diagnosis.
With this in mind, the need for a standardized flexion-extension radiograph imaging protocol to assess for spinal instability is evident. Such standardized protocols can influence the amount of intervertebral motion, both translational and rotational. Since intervertebral motion is often used as evidence for spinal instability, inadequate effort likely leads to false negatives for spinal instability. Thus, developing a standardized imaging protocol to reliably measure intervertebral motion during a flexion-extension exam is clinically significant, as it often influences the diagnosis of a patient.
- Conditions
- Lumbar Spinal Stenosis, Spinal Instability
- Being tested
- Flexion-extension radiographs
- Keywords
- Diagnostic Imaging, Decision Support Systems, Clinical, Radiographic Image Interpretation, Computer-Assisted, Surgical Decompression
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexion-extension radiographsDiagnostic test
Participants will undergo (regular) flexion-extension radiographs.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One hour after taking both sets of the flexion-extension radiographs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start27 Nov 2024
- Primary completion25 Aug 2025
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Metrics Diagnostics, Inc
- Responsible party
- Sponsor
- Investigators
- Job LC van Susante, Dr. PhD., Principal investigator, Department of orthopedics, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633550
- Sponsor's protocol ID
- NL82684.091.22
- Status last verified
- Aug 2026
- First submitted
- 10 Nov 2022
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26273555Zhao 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.
PubMed 16023484Pearson 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.
PubMed 21217439Patwardhan 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.
PubMed 22552675Auerbach 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.
PubMed 25802620Zhao 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.
PubMed 26974192Weiler 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.
PubMed 2149207Staub 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.
PubMed 26296193Hasegawa 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.
PubMed 21511932Bogduk, N., Instability, in Clinical and Radiological Anatomy of the Lumbar Spine, N. Bogduk, Editor. 2012, Elsevier Health Sciences. p. 207-216
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.
PubMed 29034136Cardis 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.
PubMed 15987704Bolus 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.
PubMed 24179182Transport, E.C.D.-G.f.E.a., European guidance on estimating population doses from medical x-ray procedures. 2008.
Environment, E.C.D.-G.f., Guidance on medical exposures in medical and biomedical research. 1999, European Commission Publications Office.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Test-retest Reliability of a Standardized Flexion - Extension Radiograph Imaging Protocol for the Lumbar Spine.
- ClinicalTrials.gov ID
- NCT05633550
- Acronym / sponsor ID
- NL82684.091.22
- Conditions
- Lumbar Spinal Stenosis, Spinal Instability
- Keywords
- Diagnostic Imaging, Decision Support Systems, Clinical, Radiographic Image Interpretation, Computer-Assisted, Surgical Decompression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Medical Metrics Diagnostics, Inc
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 25 Aug 2025 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Lumbar spinal stenosis, a narrowing of the spinal canal in the lower part of the back, is a relatively common medical problem, but optimal treatment for the condition is poorly understood. Lumbar spinal stenosis is commonly treated with decompression surgery (providing more space for the compressed nerve roots) with or without additional lumbar fusion surgery (connecting two or more vertebrae to eliminate instability). 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 personal experience. They have to subjectively gauge whether 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.
A reliable diagnostic assessment for spinal instability would ideally be validated using an existing "gold standard" test. Such a test should have a very high sensitivity and specificity and must be supported by clearly developed rationale and high-quality evidence. Unfortunately, such a test does not currently exist for spinal instability. However, abnormalities in intervertebral motion are often a hallmark for spinal instability. A commonly accepted way to examine intervertebral motion is by analyzing the patient's flexion-extension radiographs. Using these two radiographs, the spine's sagittal plane intervertebral motion can be measured. The relative motion between the two images can be measured at all relevant levels either through manual measurement or computer assisted methods. Ideally, a standardized flexion-extension radiograph imaging protocol accomplishes the following: the patient sufficiently stresses the spine in order to assess the integrity of intervertebral motion restraints (ligaments, annulus, facet capsule, etc.), it is easily implemented into the clinical work flow, and it is reliable and repeatable across subjects and clinicians.
A myriad of patient positioning protocols for the flexion-extension radiograph imaging procedure have been tested and deployed, although generally without well-validated success criteria. Despite the large amount of studies on the topic, no one flexion-extension radiograph imaging protocol has been widely accepted. This suggests that 1) the studies were not appropriately powered to influence change, 2) some protocols (methods, equipment, instructions, etc.) are not easily implemented or practical in routine clinical workflows, 3) acquiring radiograph images of the lumbar spine in sufficiently stressed positions is not widely accepted as clinically important, or 4) most ordering clinicians do not realize how often a patient fails to adequately stress the spine while undergoing a standard of care flexion-extension radiograph. One factor that can often cast doubt on the efficacy of the flexion-extension radiograph procedure is the level of patient effort or range of spinal motion achieved by the patient. For standing flexion-extension radiographs, more patient effort leads to more intervertebral motion. This is a fairly simple and intuitive concept. However, achieving maximum patient effort is not a simple task. It could be argued that symptomatic patients should not be expected to exert maximum effort because it can be painful or uncomfortable. This argument can be supplemented with evidence that fear avoidance can limit motion and intervertertebral motion is substantially increased after analgesic injections.
Despite some of the arguments that can be used against the implementation of standardized flexion-extension radiograph imaging protocols in assessing spinal instability, there is ample data that good patient effort can be obtained in symptomatic patients. In one large multi-site study of lumbar stenosis with the exact same patient inclusion/exclusion criteria, a large amount of variance can be seen in the average level of intervertebral rotation. This suggests that differences in the flexion-extension radiograph protocol could be the driving factor in this high amount of variance seen between sites. It is also possible that the physician and/or radiology technician helped to quell patient's fear of motion by explaining that the maximum flexion and extension will not injure their back and will provide the best data for a reliable diagnosis.
With this in mind, the need for a standardized flexion-extension radiograph imaging protocol to assess for spinal instability is evident. Such standardized protocols can influence the amount of intervertebral motion, both translational and rotational. Since intervertebral motion is often used as evidence for spinal instability, inadequate effort likely leads to false negatives for spinal instability. Thus, developing a standardized imaging protocol to reliably measure intervertebral motion during a flexion-extension exam is clinically significant, as it often influences the diagnosis of a patient.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A non-probability purposive sample of 45 patients will be recruited.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flexion-extension radiographsParticipants will undergo (regular) flexion-extension radiographs. | Diagnostic test | – |
Primary outcome
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.
Time frame: One hour after taking both sets of the flexion-extension radiographs
Test-retest reliability.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 26273555Hipp 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.
- Background: PubMed 16023484Zhao 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.
- Background: PubMed 21217439Pearson 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.
- Background: PubMed 22552675Patwardhan 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.
- Background: PubMed 25802620Auerbach 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.
- Background: PubMed 26974192Zhao 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.
- Background: PubMed 2149207Weiler 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.
- Background: PubMed 26296193Staub 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.
- Background: PubMed 21511932Hasegawa 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.
- BackgroundBogduk, N., Instability, in Clinical and Radiological Anatomy of the Lumbar Spine, N. Bogduk, Editor. 2012, Elsevier Health Sciences. p. 207-216
- Background: PubMed 29034136Hipp 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.
- Background: PubMed 15987704Cardis 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.
- Individual participant dataSharing planned: Undecided
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LUMBAR STENOSIS
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Job LC van Susante, Dr. PhD. principal investigator
Department of orthopedics, Rijnstate Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis and Spinal Instability, run by Rijnstate Hospital at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: One hour after taking both sets of the flexion-extension radiographs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05633550, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.