Lumbar Spinal StenosisSPSINCT03754972
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
A study testing Sagittal plane shear index (SPSI) in people with Lumbar Spinal Stenosis and Spondylolisthesis, run by Medical Metrics Diagnostics, Inc at 3 sites in Netherlands.
Trial summary
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple treatment algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Spondylolisthesis
- What is being tested?
- Sagittal plane shear index (SPSI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesNetherlands
- Study dates
- 20 Feb 2019to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms consistent with single level lumbar spinal stenosis based on judgment and experience of the investigator
- Central and or foraminal stenosis confirmed by MRI as per the investigators clinical standards
- Grades 1 (10 to 25%) or 2 (26 to 50%) anterior or retro-spondylolisthesis using the Meyerding scale [43]
- Absence of lateral spondylolisthesis
- No prior lumbar spinal surgery
- Absence of American Society of Anesthesiologists (ASA) class IV or higher disease
Show all 13Show fewer
- The single level surgical technique planned (prior to viewing the spinal motion report) to decompress the level is not expected to destabilize the spine (fusion is not deemed necessary due to probable iatrogenic instability)
- Prior to viewing the spinal motion report, the surgical plan includes decompression or decompression and fusion of only one level
- Based on the investigators subjective assessment, the patient is able to flex and extend sufficiently to facilitate acceptable flexion and extension radiographs
- The fusion technique planned prior to viewing the spinal motion report is the following: Instrumented posterior (pedicle screws and rods) with / without postero-lateral interbody fusion cage
- Subject is able to understand and sign the study Informed Consent Form
- Subjects is at least 18 years of age.
- Subject has willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions
Who cannot join
- Lumbar stenosis without spondylolisthesis
- Severe lumbar stenosis that requires a wide decompression where the investigator believes (based on experience and available research studies) that the decompression will destabilize the spine and fusion surgery is required regardless of preoperative SPSI
- Pregnant women
- Scoliosis involving a lumbar curve greater than 10 degrees
- Stenosis at the level of a transitional vertebra
- Lateral spondylolisthesis (Coronal plane translational misalignment between vertebrae)
- Prior lumbar spinal surgery
- American Society of Anesthesiologists (ASA) class IV or higher disease
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
OLVG Oost
Amsterdam
Rijnstate Hospital
Arnhem
Isala
Zwolle
About this study
Official title: The Sagittal Plane Shear Index (SPSI) for Planning Whether to Fuse After Decompressing a Stenotic Lumbar Level
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple treatment algorithm. The objective spinal stability metric is calculated from flexion-extension radiographs using previously validated methods.
Read the detailed description
Patients with previously diagnosed lumbar spinal stenosis and spondylolisthesis, who have consented to surgical treatment consisting of either decompression alone or decompression plus fusion will be invited to participate in the study. The initial surgical plan will be recorded prior to reviewing the sagittal plane shear index (SPSI). The sagittal plane shear index will be calculated flexion-extension radiographs. The measurements required to calculate SPSI will be obtained using previously validated methods. SPSI greater than 2 indicates that the translation-per-degree of rotation (TPDR) is above the upper limit of the 95% confidence interval observed in several hundred asymptomatic and radiographically normal individuals. SPSI will be reported to the surgeon after recording the pre-SPSI surgical plan. The surgeon will then decide whether to change the surgical plan. For example, if the initial surgical plan was to only decompress a level, and SPSI is greater than 2, the surgeon may plan to add fusion to the decompression. Conversely, if the initial plan was decompression plus fusion, and the SPSI indicates that the level is objectively stable, the post-SPSI plan may be to only decompress the level. The proportion of surgical plans that change after reviewing the SPSI report will be determined. If the proportion of surgical plans that change is greater than 15%, further research will be undertaken to explore whether deciding, based on objective measurement of spinal stability, whether to add fusion to decompression of a stenotic lumbar level will have a significant effect on clinical outcomes.
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis
- Being tested
- Sagittal plane shear index (SPSI)
- Keywords
- lumbar, spondylolisthesis, instability, diagnosis, treatment planning, fusion, decompression
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagittal plane shear index (SPSI)Diagnostic test
Report SPSI to surgeon after surgeon records an initial surgical plan, and determine whether the objective spinal stability metric influences a change in the surgical plan.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar spinal stenosis surgery candidate | Experimental | Patients with lumbar spinal stenosis and spondylolisthesis that have previously consented to surgical treatment. After recording the initial surgical plan, the Sagittal plane shear index (SPSI) will be provided to the surgeon. The surgeon may change the initial surgical plan based on the stability metric. Receives: Diagnostic Test: Sagittal plane shear index (SPSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning
The surgeons will record their surgical plan (decompression alone or decompression plus fusion) prior to receiving the SPSI report. The surgeon will then integrate the data in the SPSI report into their surgical planning and record a post-SPSI report surgical plan. The proportion of lumbar spinal stenosis surgery plans that change after an objective metric for spinal stability is included in the surgical planning will be determined. If the proportion of plans that change after integration of the SPSI report is greater than expected due to subjectivity in surgical planning, then the SPSI report will be considered clinically effective and further research will be pursued.
Measured: Pre-surgery
Secondary outcomes (5)
Association Between the Preoperative SPSI and the Facet Fluid Sign Observed in a Preoperative MRI
Prior research has reported that SPSI is significantly higher at lumbar levels where a facet fluid sign is observed in a MRI exam. Outcome 2 is intended to test the hypothesis that this prior finding can be repeated. SPSI will be calculated for all levels in the lumbar spine from preoperative lumbar flexion-extension radiographs. The surgeons will record whether they observe the fluid sign in the facet joints based on review of a preoperative MRI exam. Statistical tests will be performed for an association between preoperative SPSI and the presence or absence of a facet fluid sign observed by the treating surgeon in a preoperative MRI exam of the lumbar spine.
Measured: Pre-surgery
The Proportion of Surgically Decompressed Levels Where SPSI Was at Least One Standard Deviation Higher at 12 Months Compared to Preoperatively.
Prior research has documented that decompression surgery may compromise the stability of the treated level. To test whether this phenomena can be documented using the SPSI metric, SPSI measured at 12 months will be compared to SPSI measured preoperatively. This will be assessed only in patients treated with decompression alone (patients treated with fusion in addition to decompression will not be included). Statistical tests will be used to determine the proportion of levels treated using decompression only where the SPSI at 12 months was at least 1 standard deviation greater than preoperatively.
Measured: One year after surgery
Reoperation Rate at 1 and 2 Years Following Surgery
Multiple prior studies have documented reoperation rates following surgery for lumbar spinal stenosis. To test whether the reoperation rate in the current study is comparable to prior studies, clinical records will be reviewed to determine whether additional surgery was performed at the treated and/or adjacent levels. Statistical tests will be used to compare the reoperation rates at 12 and 24 months after the index surgery to reoperation rates previously reported in the peer-reviewed literature.
Measured: 12 and 24 months
Are the ODI Scores at 12 Months Following Lumbar Fusion Surgery Dependent on Whether the Treated Level is Fused, With Fusion Defined as Intervertebral Rotation < 2 Degrees and an Absence of Radiographic Signs of a Non-union.
The existing peer-reviewed literature is inconsistent with respect to the hypothesis that the Oswestry Disability Index (ODI) is affected by a non-union of a lumbar level treated using fusion surgery. The ODI quantifies disability related to low back pain. The ODI is measured on a scale of 0 to 100, with higher scores indicating greater disability. The ODI will be recorded preoperatively and at 12 months following surgery. Each lumbar level will be classified as fused if intervertebral rotation between flexion and extension is < 2 degrees and there is an absence of a discontinuity in bone bridging between vertebrae. The ODI at 12 months, as well as the change in ODI relative to preoperative outcomes will be compared for subjects classified as fused versus not-fused. This test will only be performed for subjects where the stenotic lumbar level was treated using decompression and fusion.
Measured: 12 months
Is Leg Pain at 12 Months Following Lumbar Fusion Surgery Dependent on Whether the Treated Level is Fused, With Fusion Defined as Intervertebral Rotation < 2 Degrees and an Absence of Radiographic Signs of a Non-union
The existing peer-reviewed literature is inconsistent with respect to the hypothesis that leg pain assessed using a Numerical Rating Scale (NRS) is affected by a non-union of a lumbar level treated using fusion surgery. Leg pain is measured on a scale of 1 to 10, with higher scores indicating worse leg pain. Leg pain will be recorded preoperatively and at 12 months following surgery. Each lumbar level will be classified as fused if intervertebral rotation between flexion and extension is < 2 degrees and there is an absence of a discontinuity in bone bridging between vertebrae. The leg pain NRS data at 12 months, as well as the change in leg pain relative to preoperative outcomes will be compared for subjects classified as fused versus not-fused. This test will only be performed for subjects where the stenotic lumbar level was treated using decompression and fusion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start20 Feb 2019
- Primary completion1 Sep 2023
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Determine whether an objective metric for spinal stability will change the surgical treatment plan in a significant proportion of patients with lumbar spinal stenosis
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Metrics Diagnostics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
- Investigators
- John Hipp, PhD, Principal investigator, Medical Metrics Diagnostics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754972
- Sponsor's protocol ID
- SPSI-01
- Acronym
- SPSI
- Status last verified
- May 2025
- First submitted
- 14 Nov 2018
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: No current plan to share data from this pilot study
Publications
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.
PubMed 26296193Rihn JA, Lee JY, Khan M, Ulibarri JA, Tannoury C, Donaldson WF 3rd, Kang JD. Does lumbar facet fluid detected on magnetic resonance imaging correlate with radiographic instability in patients with degenerative lumbar disease? Spine (Phila Pa 1976). 2007 Jun 15;32(14):1555-60. doi: 10.1097/BRS.0b013e318067dc55.
PubMed 17572627Hipp 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 26273555Leone A, Guglielmi G, Cassar-Pullicino VN, Bonomo L. Lumbar intervertebral instability: a review. Radiology. 2007 Oct;245(1):62-77. doi: 10.1148/radiol.2451051359.
PubMed 17885181Zhao 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 21217439Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.
PubMed 27074066Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.
PubMed 27074067Machado GC, Ferreira PH, Yoo RI, Harris IA, Pinheiro MB, Koes BW, van Tulder MW, Rzewuska M, Maher CG, Ferreira ML. Surgical options for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016 Nov 1;11(11):CD012421. doi: 10.1002/14651858.CD012421.
PubMed 27801521Jansson KA, Nemeth G, Granath F, Blomqvist P. Spinal stenosis re-operation rate in Sweden is 11% at 10 years--a national analysis of 9,664 operations. Eur Spine J. 2005 Sep;14(7):659-63. doi: 10.1007/s00586-004-0851-9. Epub 2005 Mar 8.
PubMed 15754213Tsutsumimoto T, Shimogata M, Yoshimura Y, Misawa H. Union versus nonunion after posterolateral lumbar fusion: a comparison of long-term surgical outcomes in patients with degenerative lumbar spondylolisthesis. Eur Spine J. 2008 Aug;17(8):1107-12. doi: 10.1007/s00586-008-0695-9. Epub 2008 Jun 7.
PubMed 18536941Eliasberg CD, Kelly MP, Ajiboye RM, SooHoo NF. Complications and Rates of Subsequent Lumbar Surgery Following Lumbar Total Disc Arthroplasty and Lumbar Fusion. Spine (Phila Pa 1976). 2016 Jan;41(2):173-81. doi: 10.1097/BRS.0000000000001180.
PubMed 26751061Makino T, Kaito T, Fujiwara H, Ishii T, Iwasaki M, Yoshikawa H, Yonenobu K. Does fusion status after posterior lumbar interbody fusion affect patient-based QOL outcomes? An evaluation performed using a patient-based outcome measure. J Orthop Sci. 2014 Sep;19(5):707-12. doi: 10.1007/s00776-014-0591-6. Epub 2014 Jun 12.
PubMed 24916199
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sagittal Plane Shear Index (SPSI) for Planning Whether to Fuse After Decompressing a Stenotic Lumbar Level
- ClinicalTrials.gov ID
- NCT03754972
- Acronym / sponsor ID
- SPSI / SPSI-01
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis
- Keywords
- lumbar, spondylolisthesis, instability, diagnosis, treatment planning, fusion, decompression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medical Metrics Diagnostics, IncIndustry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 20 Feb 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Posted 31 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple treatment algorithm. The objective spinal stability metric is calculated from flexion-extension radiographs using previously validated methods.
Detailed description
Patients with previously diagnosed lumbar spinal stenosis and spondylolisthesis, who have consented to surgical treatment consisting of either decompression alone or decompression plus fusion will be invited to participate in the study. The initial surgical plan will be recorded prior to reviewing the sagittal plane shear index (SPSI). The sagittal plane shear index will be calculated flexion-extension radiographs. The measurements required to calculate SPSI will be obtained using previously validated methods. SPSI greater than 2 indicates that the translation-per-degree of rotation (TPDR) is above the upper limit of the 95% confidence interval observed in several hundred asymptomatic and radiographically normal individuals. SPSI will be reported to the surgeon after recording the pre-SPSI surgical plan. The surgeon will then decide whether to change the surgical plan. For example, if the initial surgical plan was to only decompress a level, and SPSI is greater than 2, the surgeon may plan to add fusion to the decompression. Conversely, if the initial plan was decompression plus fusion, and the SPSI indicates that the level is objectively stable, the post-SPSI plan may be to only decompress the level. The proportion of surgical plans that change after reviewing the SPSI report will be determined. If the proportion of surgical plans that change is greater than 15%, further research will be undertaken to explore whether deciding, based on objective measurement of spinal stability, whether to add fusion to decompression of a stenotic lumbar level will have a significant effect on clinical outcomes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Determine whether an objective metric for spinal stability will change the surgical treatment plan in a significant proportion of patients with lumbar spinal stenosis
| Arm | Type | Receives |
|---|---|---|
| Lumbar spinal stenosis surgery candidate | Experimental | Diagnostic Test: Sagittal plane shear index (SPSI)Patients with lumbar spinal stenosis and spondylolisthesis that have previously consented to surgical treatment. After recording the initial surgical plan, the Sagittal plane shear index (SPSI) will be provided to the surgeon. The surgeon may change the initial surgical plan based on the stability metric. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Symptoms consistent with single level lumbar spinal stenosis based on judgment and experience of the investigator
- Central and or foraminal stenosis confirmed by MRI as per the investigators clinical standards
- Grades 1 (10 to 25%) or 2 (26 to 50%) anterior or retro-spondylolisthesis using the Meyerding scale [43]
- Absence of lateral spondylolisthesis
- No prior lumbar spinal surgery
Key exclusion criteria (8 listed)
- Lumbar stenosis without spondylolisthesis
- Severe lumbar stenosis that requires a wide decompression where the investigator believes (based on experience and available research studies) that the decompression will destabilize the spine and fusion surgery is required regardless of preoperative SPSI
- Pregnant women
- Scoliosis involving a lumbar curve greater than 10 degrees
- Stenosis at the level of a transitional vertebra
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 |
|---|---|---|
| Sagittal plane shear index (SPSI)Report SPSI to surgeon after surgeon records an initial surgical plan, and determine whether the objective spinal stability metric influences a change in the surgical plan. | Diagnostic test | Lumbar spinal stenosis surgery candidate |
Primary outcome
Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning
Time frame: Pre-surgery
The surgeons will record their surgical plan (decompression alone or decompression plus fusion) prior to receiving the SPSI report. The surgeon will then integrate the data in the SPSI report into their surgical planning and record a post-SPSI report surgical plan. The proportion of lumbar spinal stenosis surgery plans that change after an objective metric for spinal stability is included in the surgical planning will be determined. If the proportion of plans that change after integration of the SPSI report is greater than expected due to subjectivity in surgical planning, then the SPSI report will be considered clinically effective and further research will be pursued.
5 secondary outcomes
Association Between the Preoperative SPSI and the Facet Fluid Sign Observed in a Preoperative MRI
Time frame: Pre-surgery
The Proportion of Surgically Decompressed Levels Where SPSI Was at Least One Standard Deviation Higher at 12 Months Compared to Preoperatively.
Time frame: One year after surgery
Reoperation Rate at 1 and 2 Years Following Surgery
Time frame: 12 and 24 months
Are the ODI Scores at 12 Months Following Lumbar Fusion Surgery Dependent on Whether the Treated Level is Fused, With Fusion Defined as Intervertebral Rotation < 2 Degrees and an Absence of Radiographic Signs of a Non-union.
Time frame: 12 months
Is Leg Pain at 12 Months Following Lumbar Fusion Surgery Dependent on Whether the Treated Level is Fused, With Fusion Defined as Intervertebral Rotation < 2 Degrees and an Absence of Radiographic Signs of a Non-union
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 17572627Rihn JA, Lee JY, Khan M, Ulibarri JA, Tannoury C, Donaldson WF 3rd, Kang JD. Does lumbar facet fluid detected on magnetic resonance imaging correlate with radiographic instability in patients with degenerative lumbar disease? Spine (Phila Pa 1976). 2007 Jun 15;32(14):1555-60. doi: 10.1097/BRS.0b013e318067dc55.
- 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 17885181Leone A, Guglielmi G, Cassar-Pullicino VN, Bonomo L. Lumbar intervertebral instability: a review. Radiology. 2007 Oct;245(1):62-77. doi: 10.1148/radiol.2451051359.
- 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 27074066Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.
- Background: PubMed 27074067Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.
- Background: PubMed 27801521Machado GC, Ferreira PH, Yoo RI, Harris IA, Pinheiro MB, Koes BW, van Tulder MW, Rzewuska M, Maher CG, Ferreira ML. Surgical options for lumbar spinal stenosis. Cochrane Database Syst Rev. 2016 Nov 1;11(11):CD012421. doi: 10.1002/14651858.CD012421.
- Background: PubMed 15754213Jansson KA, Nemeth G, Granath F, Blomqvist P. Spinal stenosis re-operation rate in Sweden is 11% at 10 years--a national analysis of 9,664 operations. Eur Spine J. 2005 Sep;14(7):659-63. doi: 10.1007/s00586-004-0851-9. Epub 2005 Mar 8.
- Background: PubMed 18536941Tsutsumimoto T, Shimogata M, Yoshimura Y, Misawa H. Union versus nonunion after posterolateral lumbar fusion: a comparison of long-term surgical outcomes in patients with degenerative lumbar spondylolisthesis. Eur Spine J. 2008 Aug;17(8):1107-12. doi: 10.1007/s00586-008-0695-9. Epub 2008 Jun 7.
- Background: PubMed 26751061Eliasberg CD, Kelly MP, Ajiboye RM, SooHoo NF. Complications and Rates of Subsequent Lumbar Surgery Following Lumbar Total Disc Arthroplasty and Lumbar Fusion. Spine (Phila Pa 1976). 2016 Jan;41(2):173-81. doi: 10.1097/BRS.0000000000001180.
- Individual participant dataSharing planned: Undecided. No current plan to share data from this pilot study
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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.
John Hipp, PhD principal investigator
Medical Metrics Diagnostics, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sagittal plane shear index (SPSI) in people with Lumbar Spinal Stenosis and Spondylolisthesis, run by Medical Metrics Diagnostics, Inc at 3 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 13 inclusion and 8 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 31 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning (time frame: Pre-surgery). 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 NCT03754972, which also lists 13 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 29 May 2025.