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Pedicle Osteotomy for Stenosis Trial (POST)

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ClinicalTrials.gov Identifier: NCT03381677
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Innovative Surgical Designs

Tracking Information
First Submitted Date  ICMJE November 28, 2017
First Posted Date  ICMJE December 22, 2017
Last Update Posted Date April 6, 2018
Actual Study Start Date  ICMJE October 26, 2017
Estimated Primary Completion Date October 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • Zurich Claudication Questionnaire (ZCQ) [ Time Frame: 24 months ]
    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
  • No reoperations [ Time Frame: Index level ]
    No re-operations, removals, revisions or supplemental fixation at the index level.
  • Adjacent level surgery [ Time Frame: 24 months ]
    No additional surgery at the adjacent levels
  • Adverse events [ Time Frame: 24 months ]
    No major device-related adverse events
  • Radiological Success [ Time Frame: 24 months ]
    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)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03381677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2017)
  • Oswestry Disability Index [ Time Frame: 24 months ]
    Improvement in Oswestry Disability Index v2.1a > 15 points from baseline to 24 months
  • EQ5D [ Time Frame: 24 months ]
    Change in EQ5D from baseline to 24 months
  • SF-12 [ Time Frame: 24 months ]
    Change in SF-12v2.0™ from baseline to 24 months
  • Pain Visual Analog Scale (VAS) for Back and Leg [ Time Frame: 24 months ]
    Pain Visual Analog Scale (VAS) is a measure of pain intensity. It is a continuous scale comprised of a 100mm line ranging from 0 (no pain) to 10 (worst imaginable pain). Patients mark a line on the scale depicting their pain level. A VAS score is determined by measuring where the mark is made relative to the ends of the line. VAS will be done separately for low back, right leg and left leg pain.Improvement in VAS for back, right leg and left leg pain of 20/100mm from baseline to 24 months
  • Cost [ Time Frame: Index surgery ]
    Direct costs of the episode of care
  • Opioid use [ Time Frame: baseline to 24 months ]
    Use of opioid analgesics
  • Return to work [ Time Frame: Anytime from discharge after surgery up to 24 months (+/- 60 days) ]
    Patient will report the date of which they return to work
  • Daily activities [ Time Frame: baseline to 24 months ]
    Time for return to usual daily activities
  • Patient Satisfaction [ Time Frame: 24 months ]
    A series of questions intended to assess the effects of the procedure itself on your well-being, and does not refer to the hospital or its staff. One out of 5 statements will be chosen based on the patient's level of satisfaction: The procedure results met my expectations and I feel better than I did before surgery; The procedure improved my condition enough that I would go through it again for the same outcome; The procedure helped me but I would not go through it again for the same outcome; I feel the same or worse compared to before surgery. Furthermore, patients will be ask to choose one statement based on how they feel today compared to their last visit: I feel much better; I feel somewhat better; I feel somewhat worse; I feel much worse.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pedicle Osteotomy for Stenosis Trial
Official Title  ICMJE A Prospective, Multi-Center, Randomized Concurrently Controlled Trial to Evaluate the Safety and Effectiveness of the Altum® Pedicle Osteotomy System for Use in Lumbar Spinal Stenosis
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.
Detailed Description

LSS is a narrowing of the spinal canal and/or the intervertebral foramina by bony spurs or soft tissues that decrease space for the neural elements resulting in compression of the nerve roots or spinal cord in the lumbar region of the spine. LSS can cause low back pain, weakness, numbness, and pain and loss of sensation in the buttocks and legs. In most cases the symptoms improve when the patient is sitting or leaning forward, due to the flexed position of the vertebra which leads to reduced impingement of the neural tissue. In addition, many patients with LSS complain of pain when standing and walking referred to as neurogenic intermittent claudication (NIC). Nonsurgical management is well-established as the first-line treatment approach for LSS patients with mild to moderate symptoms. It typically involves the prescription of modified physical activity, physiotherapy, anti-inflammatory drugs, epidural steroid injections, use of a lumbar corset or some combination thereof.

Surgical treatment is reserved for patients who do not obtain adequate relief of symptoms by conservative management. The goal of surgical treatment for LSS is to relieve the compression of the spinal nerves in the spinal canal or neural foramina. Such decompressive surgery generally involves laminectomy, laminotomy, foraminotomy, partial facetectomy or some combination thereof. Decompressive surgery in subjects with LSS and spondylolisthesis commonly requires fusion to stabilize the spondylolisthesis. The most commonly performed lumbar fusion for patient's with the combination of LSS and spondylolisthesis is a Transforaminal Lumbar Interbody Fusion (TLIF) which involves stabilizing the motion segment by placing pedicle screws, rods and an interbody fusion cage. Autograft or allograft bone are commonly used to bring about fusion or a bridging of bone across the intervertebral joint.

The Altum® Pedicle Osteotomy System contains the implants and instruments required to perform the pedicle lengthening osteotomy procedure for the treatment of LSS. The Altum® implant is an expandable bone screw that is available in a variety of sizes (7.5 mm, 8.5 mm and 9.5 mm). Altum® instruments are manufactured from IXEF PARA GS-1022 GY/51, medical grade titanium alloy (Ti 6AL-4V ELI ASTM F-136), and medical grade stainless steel (17-4 ASTM F899).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Lumbar Spinal Stenosis
  • Spondylolisthesis, Grade 1
  • Neurogenic Claudication
Intervention  ICMJE
  • Device: Pedicle Lengthening Osteotomy with Altum® 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.
  • Device: Control

    Decompressive surgery via open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) 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 or Medtronic CD Horizon Solera 5.5 System or Innovative Surgical Designs True System for fixation; and
    2. DePuy Synthes TLIF cage, Metronic TLIF cage or Meditech Talos TLIF cage.
Study Arms  ICMJE
  • Experimental: Pedicle Lengthening Osteotomy
    Lumbar decompressive surgery via Pedicle Lengthening Osteotomy Procedure with the Altum® Device
    Intervention: Device: Pedicle Lengthening Osteotomy with Altum® Device
  • Active Comparator: Control group

    Decompressive surgery via open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) 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 or Medtronic CD Horizon Solera 5.5 System or Innovative Surgical Designs True System for fixation; and
    2. DePuy Synthes TLIF cage, Metronic TLIF cage or Meditech Talos TLIF cage.
    Intervention: Device: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2017)
344
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 26, 2024
Estimated Primary Completion Date October 26, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Is a male or female patient between 40 and 80 years of age.
  2. 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.
  3. 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.
  4. Has pain in the leg and/or buttock that is worse with standing as compared to sitting.
  5. 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.
  6. 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
  7. 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.
  8. Has moderate or greater impairment on the Zurich Claudication Questionnaire (ZCQ) Physical Function scale (PF) defined as a score of 2 or greater.
  9. Has moderate or greater impairment on the Oswestry Disability Index defined as a score of 30 or greater.
  10. Is a surgical candidate for lumbar decompressive surgery at one or two levels in the L2 through L5 region of the spine.
  11. Is psychosocially, mentally and physically able to comply with all study procedures required by the study protocol including attending all scheduled visits and interventions.
  12. Is able to provide voluntary, informed consent to participate in the clinical trial and has signed the informed consent documents.

Exclusion Criteria:

  1. Has had prior spinal surgery at any level between L1 and S1.
  2. Requires more than 2 lumbar levels of surgical decompression.
  3. 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.
  4. 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.
  5. Has a complete motor or sensory deficit.
  6. Has a pars defect.
  7. Has facet joints at the implant level that are absent or fractured.
  8. Has lumbar scoliosis with a Cobb angle of greater than 25o.
  9. Has a disc herniation at any lumbar level requiring surgical intervention.
  10. Has symptomatic hip arthritis or hip pain.
  11. Has a Body Mass Index (BMI) of greater than 40.
  12. Has a known allergy to titanium or titanium alloys.
  13. 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.
  14. Has a history of Paget's disease, osteomalacia, or any other metabolic bone disease.
  15. Has a history of rheumatoid arthritis or other systemic autoimmune disease.
  16. Requires medications or drugs known to interfere with bone/soft tissue healing (e.g., chronic systemic corticosteroids). Corticosteroids used for 6 weeks or less are not an exclusion criteria.
  17. Has insulin dependent diabetes mellitus.
  18. Has cauda equina syndrome, defined as neural compression in the lumbar spine causing neurogenic bowel (rectal incontinence) or neurogenic bladder (bladder retention or incontinence) dysfunction.
  19. Only has axial back pain with no leg or buttock pain.
  20. Has back or leg pain of unknown etiology.
  21. Has evidence or the diagnosis of significant peripheral vascular disease (e.g. diminished or absent dorsalis pedis or posterior tibial pulses)
  22. The patient currently has any of the following: schizophrenia, bipolar disorder, major depression, major psychotic disorder, and substance or alcohol abuse or dependency as defined by the DSM V.
  23. Has participated in a clinical trial of another investigational drug or device within the past 2 years.
  24. Has an active, chronic infection, either systemic or local.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Charles Ledonio, MD (484) 584-4229 cledonio@innovativesd.net
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03381677
Other Study ID Numbers  ICMJE A-2016-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Innovative Surgical Designs
Study Sponsor  ICMJE Innovative Surgical Designs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Charles Ledonio, MD Innovative Surgical Designs
PRS Account Innovative Surgical Designs
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP