Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery

NCT03754972 | Completed Results DMC

• 1 other identifier: SPSI-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Lumbar Spinal Stenosis; Spondylolisthesis

Keywords

lumbar; spondylolisthesis; instability; diagnosis; treatment planning; fusion; decompression

Outcome Measures

Primary Outcomes (1)

• 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.

  Pre-surgery

Secondary Outcomes (5)

• Association Between the Preoperative SPSI and the Facet Fluid Sign Observed in a Preoperative MRI

  Pre-surgery

• The Proportion of Surgically Decompressed Levels Where SPSI Was at Least One Standard Deviation Higher at 12 Months Compared to Preoperatively.

  One year after surgery

• Reoperation Rate at 1 and 2 Years Following Surgery

  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.

  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

  12 months

Study Arms (1)

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.

Diagnostic Test: Sagittal plane shear index (SPSI)

Interventions

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.

Lumbar spinal stenosis surgery candidate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Metrics Diagnostics, Inc: lead
• Avania: collaborator

Study Sites (3)

OLVG Oost

Amsterdam, Netherlands

Location

Rijnstate Hospital

Arnhem, Netherlands

Location

Isala

Zwolle, Netherlands

Location

Related Publications (13)

• 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.

  PMID: 26296193 BACKGROUND

• 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.

  PMID: 17572627 BACKGROUND

• 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.

  PMID: 26273555 BACKGROUND

• 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.

  PMID: 17885181 BACKGROUND

• 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.

  PMID: 16023484 BACKGROUND

• 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.

  PMID: 21217439 BACKGROUND

• 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.

  PMID: 27074066 BACKGROUND

• 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.

  PMID: 27074067 BACKGROUND

• Machado 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.

  PMID: 27801521 BACKGROUND

• Jansson 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.

  PMID: 15754213 BACKGROUND

• Tsutsumimoto 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.

  PMID: 18536941 BACKGROUND

• Eliasberg 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.

  PMID: 26751061 BACKGROUND

• Makino 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.

  PMID: 24916199 BACKGROUND

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Disease

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No limitations

Results Point of Contact

• Title: Trevor Grieco
• Organization: Medical Metrics, Inc

tgrieco@medicalmetrics.com

713-850-7500

Study Officials

• John Hipp, PhD

  Medical Metrics Diagnostics, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Determine whether an objective metric for spinal stability will change the surgical treatment plan in a significant proportion of patients with lumbar spinal stenosis

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 27, 2018
• Study Start: February 20, 2019
• Primary Completion: September 1, 2023
• Study Completion: March 1, 2025
• Last Updated: May 29, 2025
• Results First Posted: July 31, 2024

Record last verified: 2025-05

Locations

NL (3)