Pedicle Osteotomy for Stenosis Trial

NCT03381677 | Suspended FDA Device

• 1 other identifier: A-2016-01
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) in patients with symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative spondylolisthesis requiring surgical treatment.

Conditions

Lumbar Spinal Stenosis; Spondylolisthesis, Grade 1; Neurogenic Claudication

Keywords

pedicle lengthening osteotomy; spinal stenosis; decompression

Outcome Measures

Primary Outcomes (5)

• Zurich Claudication Questionnaire (ZCQ)

  Clinically significant improvement in outcomes ZCQ scores compared to baseline * Improvement in physical function by \> 0.5 points * Improvement in symptom severity by \> 0.5 points * "Satisfied" or "somewhat satisfied" as defined by a score of \< 2.5 points on the patient satisfaction domain

  24 months

• No reoperations

  No re-operations, removals, revisions or supplemental fixation at the index level.

  Index level

• Adjacent level surgery

  No additional surgery at the adjacent levels

  24 months

• Adverse events

  No major device-related adverse events

  24 months

• Radiological Success

  Presence of continuous bridging bone across both pedicle osteotomy sites on CT scanning, * No evidence of bridging bone between the upper and lower vertebral endplates on CT scanning, and evidence of continued motion as demonstrated on flexion-extension films * Absence of a major device related adverse event (device breakage, disassembly or migration)

  24 months

Secondary Outcomes (9)

• Oswestry Disability Index

  24 months

• EQ5D

  24 months

• SF-12

  24 months

• Pain Visual Analog Scale (VAS) for Back and Leg

  24 months

• Cost

  Index surgery

Study Arms (2)

Pedicle Lengthening Osteotomy

EXPERIMENTAL

Lumbar decompressive surgery via Pedicle Lengthening Osteotomy Procedure with the Altum® Device

Device: Pedicle Lengthening Osteotomy with Altum® Device

Control group

ACTIVE COMPARATOR

Decompressive surgery via open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) using either a midline or paramedian incision with implantation of bilateral pedicle screws (4 screws) and rods (2 rods) and an interbody fusion cage (1 PEEK fusion cage, coated or uncoated): 1. DePuy Synthes Expedium® 5.5 System, Stryker Xia 5.5 System, Medtronic CD Horizon Solera 5.5 Systemor Innovative Surgical Designs True Spinal Fixation System; and 2. DePuy Synthes Concord TLIF cage, Stryker UniLIF TLIF cage, Medtronic Capstone TLIF cage or Meditech Talos TLIF cage.

Device: Control

Interventions

Pedicle Lengthening Osteotomy with Altum® Device DEVICE

Decompressive surgery via Pedicle lengthening osteotomy using Altum Device. Altum is intended for pedicle lengthening to correct degenerative lumbar spinal stenosis in the presence of a grade 1 degenerative spondylolisthesis. The Altum bone saw is designed for creating an osteotomy at the base of each pedicle. The Altum implant is designed for distraction of the pedicle osteotomy and for lengthening of the pedicles. Altum is appropriate for skeletally mature adults with symptomatic stenosis at one or two levels between L2-L5.

Pedicle Lengthening Osteotomy

Control DEVICE

Decompressive surgery via open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) using either a midline or paramedian incision with implantation of bilateral pedicle screws (4 screws) and rods (2 rods) and an interbody fusion cage (1 PEEK fusion cage, coated or uncoated): 1. DePuy Synthes Expedium® 5.5 System, Stryker Xia 5.5 System, Medtronic CD Horizon Solera 5.5 Systemor Innovative Surgical Designs True Spinal Fixation System; and 2. DePuy Synthes Concord TLIF cage, Stryker UniLIF TLIF cage, Medtronic Capstone TLIF cage or Meditech Talos TLIF cage.

Control group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a male or female patient between 40 and 80 years of age.
• Has the diagnosis of degenerative spinal stenosis of the lumbar region (defined as L2-L5), defined by one or more of the following: a) narrowingof the mid-sagittal spinal canal (central stenosis), b) narrowing between the facet superior articular process (SAP) and the posterior intervertebral disc margin (lateral recess stenosis), c) narrowing of the nerve root foraminal canal(s) (foraminal stenosis) and has, at the same level, radiographic confirmation on plain lateral flexion/extension radiographs of a degenerative grade I spondylolisthesis at the same level, defined as at least 1% but not greater than 25%, offset between the posterior margins of the adjacent vertebral bodies at the index level.
• Neurogenic claudication or radiculopathic symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain, which is worse with extended posture and relieved by flexion, as evidenced by patient history.
• Has pain in the leg and/or buttock that is worse with standing as compared to sitting.
• Has radiographic confirmation on CT or MRI of moderate or greater lumbar spinal stenosis at the index level defined as \> 25% reduction in area of the central and/or lateral recess and/or foraminal regions of the spinal canal as compared to the adjacent level.
• Has radiographic confirmation on CT or MRI of compression of the thecal sac and/or cauda equina and/or nerve root(s) due to hypertrophy of the facet joints and/or ligamentum flavum thickening/buckling
• Has undergone a 6 month or longer course of conservative therapy without sufficient relief of symptoms that has included one or more of the following interventions: physical therapy, bracing, systemic and/or injected medications.
• Has moderate or greater impairment on the Zurich Claudication Questionnaire (ZCQ) Physical Function scale (PF) defined as a score of 2 or greater.
• Has moderate or greater impairment on the Oswestry Disability Index defined as a score of 30 or greater.
• Is a surgical candidate for lumbar decompressive surgery at one or two levels in the L2 through L5 region of the spine.
• Is psychosocially, mentally and physically able to comply with all study procedures required by the study protocol including attending all scheduled visits and interventions.
• Is able to provide voluntary, informed consent to participate in the clinical trial and has signed the informed consent documents.

You may not qualify if:

• Has had prior spinal surgery at any level between L1 and S1.
• Requires more than 2 lumbar levels of surgical decompression.
• Has a degenerative spondylolisthesis of greater than grade I defined as greater than 25% offset between the posterior margins of adjacent vertebral bodies on plain lateral flexion/extension radiographs or does not have a grade I degenerative spondylolisthesis, defined as 0% offset between the posterior margins of adjacent vertebral bodies on a plain lateral flexion/extension radiograph.
• Has more than one level of degenerative spondylolisthesis or has spondylolisthesis located at lumbar levels which are not treated with surgical decompression. Has the diagnosis of peripheral neuropathy.
• Has a complete motor or sensory deficit.
• Has a pars defect.
• Has facet joints at the implant level that are absent or fractured.
• Has lumbar scoliosis with a Cobb angle of greater than 25o.
• Has a disc herniation at any lumbar level requiring surgical intervention.
• Has symptomatic hip arthritis or hip pain.
• Has a Body Mass Index (BMI) of greater than 40.
• Has a known allergy to titanium or titanium alloys.
• Has osteoporosis. The SCORE (Simple Calculated Osteoporosis Risk Estimation) will be used to screen subjects who require DEXA; Subjects with T-score \< -2.5 (per The World Health Organization definition) will be excluded.
• Has a history of Paget's disease, osteomalacia, or any other metabolic bone disease.
• Has a history of rheumatoid arthritis or other systemic autoimmune disease.

Sponsors & Collaborators

• Innovative Surgical Designs: lead

Study Sites (1)

Rothman Institute

Bryn Mawr, Pennsylvania, 19010, United States

Location

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jon Rinehart

  Sponsor GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 22, 2017
• Study Start: October 26, 2017
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2024
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

US (1)