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Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery (SPSI)

Primary Purpose

Lumbar Spinal Stenosis

Status

Active

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Sagittal plane shear index (SPSI)

About this trial

This is an interventional diagnostic trial for Lumbar Spinal Stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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

Sites / Locations

OLVG Oost
Rijnstate Hospital
Isala

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Lumbar spinal stenosis surgery candidate

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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 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.

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 measured using a NRS 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.

Full Information

NCT ID

NCT03754972

First Posted

November 14, 2018

Last Updated

December 20, 2022

Sponsor

Medical Metrics Diagnostics, Inc

Collaborators

Avania

1. Study Identification

Unique Protocol Identification Number

NCT03754972

Brief Title

Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery

Acronym

SPSI

Official Title

The Sagittal Plane Shear Index (SPSI) for Planning Whether to Fuse After Decompressing a Stenotic Lumbar Level

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 20, 2019 (Actual)

Primary Completion Date

December 1, 2022 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical Metrics Diagnostics, Inc

Collaborators

Avania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lumbar Spinal Stenosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

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)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lumbar spinal stenosis surgery candidate

Arm Type

Experimental

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Sagittal plane shear index (SPSI)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of surgical plans recorded prior to the SPSI report that are altered after integration of SPSI into the surgical planning

Description

Time Frame

Pre-surgery

Secondary Outcome Measure Information:

Title

Association between the preoperative SPSI and the facet fluid sign observed in a preoperative MRI

Description

Time Frame

Pre-surgery

Title

The proportion of surgically decompressed levels where SPSI was at least one standard deviation higher at 12 months compared to preoperatively.

Description

Time Frame

One year after surgery

Title

Reoperation rate at 1 and 2 years following surgery

Description

Time Frame

12 and 24 months

Title

Description

Time Frame

12 months

Title

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Hipp, PhD

Organizational Affiliation

Medical Metrics Diagnostics, Inc

Official's Role

Principal Investigator

Facility Information:

Facility Name

OLVG Oost

City

Amsterdam

Country

Netherlands

Facility Name

Rijnstate Hospital

City

Arnhem

Country

Netherlands

Facility Name

Isala

City

Zwolle

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

No current plan to share data from this pilot study

Citations:

PubMed Identifier

26296193

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.

Results Reference

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PubMed Identifier

17572627

Citation

Rihn 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.

Results Reference

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PubMed Identifier

26273555

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.

Results Reference

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PubMed Identifier

17885181

Citation

Leone 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.

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PubMed Identifier

16023484

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.

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PubMed Identifier

21217439

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.

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PubMed Identifier

27074066

Citation

Forsth 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.

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Citation

Ghogawala 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.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery

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