search
Back to results

MagnetOs Putty Compared to Trinity Evolution in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion (PRECISE)

Primary Purpose

Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MagnetOs Putty
Sponsored by
Kuros Biosurgery AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative Disc Disease, Spine Fusion

Eligibility Criteria

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

Inclusion Criteria:

  • Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
  • Male or female patient ≥ 18 years old.
  • Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1)
  • Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment.

Exclusion Criteria:

  • Requires > four-level fusion or expected to need secondary intervention within one year following surgery.
  • To treat conditions in which general bone grafting is not advisable.
  • In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible).
  • In case of significant vascular impairment proximal to the graft site.
  • In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
  • In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
  • When intraoperative soft tissue coverage is not planned or possible.
  • Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
  • Receiving treatment with medication interfering with calcium metabolism.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    MagnetOs Putty

    Trinity Evolution

    Arm Description

    MagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side

    Trinity Evolution is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side.

    Outcomes

    Primary Outcome Measures

    Radiographic Fusion by CT Scan
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.

    Secondary Outcome Measures

    Radiographic Fusion by Plain Radiographs
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
    Radiographic Fusion by CT Scan
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 6. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
    Functional Outcome by Oswestry Disability Index
    Functional outcome by the Oswestry Disability Index questionnaire. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability.
    Back and Leg Pain by Visual Analog Pain Scale (VAS)
    Change in back and leg pain using Visual Analog Pain Scale score. The patient completed questionnaire is a unidimensional measure of pain intensity using a continuous scale comprised of a horizontal line 10 centimeters (100 mm) in length. The line is anchored by "no pain" (score of 0) and "worst imaginable pain". A higher score indicates greater pain intensity.
    Neurologic Status by Physical Exam
    Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for lower extremities, specifically reflexes, muscle strength, sensory, and straight leg raise.
    Success Rate
    Number of patients with secondary surgical interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or removes part of the original implant configuration with or without replacement of the components within 12 months of surgery.

    Full Information

    First Posted
    August 31, 2021
    Last Updated
    January 26, 2022
    Sponsor
    Kuros Biosurgery AG
    Collaborators
    Simplified Clinical Data Systems, LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05037968
    Brief Title
    MagnetOs Putty Compared to Trinity Evolution in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
    Acronym
    PRECISE
    Official Title
    A Prospective, Randomized, Single-center Study to Assess the Performance of MagnEtOsTM Putty Compared to Trinity EvolutionTM in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kuros Biosurgery AG
    Collaborators
    Simplified Clinical Data Systems, LLC

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery. In this study, MagnetOs Putty will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine. Trinity Evolution will also be used according to its latest IFU approved in the US. Specifically, Trinity Evolution is an allograft intended for the treatment of musculoskeletal defects.
    Detailed Description
    In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to four-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and Trinity Evolution on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 4, Month 6, and Month 12. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12. In this study, MagnetOs Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol% in patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion. Radiographs will be obtained at Screening, Week 6, Month 4, Month 6 and Month 12. CT-scans will only be obtained at Month 6 and Month 12.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
    Keywords
    Degenerative Disc Disease, Spine Fusion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Parallel Assignment, Intra-patient control. Each patient serves as their own control.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MagnetOs Putty
    Arm Type
    Experimental
    Arm Description
    MagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side
    Arm Title
    Trinity Evolution
    Arm Type
    Active Comparator
    Arm Description
    Trinity Evolution is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side.
    Intervention Type
    Device
    Intervention Name(s)
    MagnetOs Putty
    Intervention Description
    Procedure: Instrumented Posterolateral Lumbar Fusion
    Primary Outcome Measure Information:
    Title
    Radiographic Fusion by CT Scan
    Description
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
    Time Frame
    Month 12
    Secondary Outcome Measure Information:
    Title
    Radiographic Fusion by Plain Radiographs
    Description
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
    Time Frame
    Week 2, Week 6, Month 3
    Title
    Radiographic Fusion by CT Scan
    Description
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 6. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
    Time Frame
    Month 6
    Title
    Functional Outcome by Oswestry Disability Index
    Description
    Functional outcome by the Oswestry Disability Index questionnaire. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability.
    Time Frame
    Week 2, Week 6, Month 3, Month 6, Month 12
    Title
    Back and Leg Pain by Visual Analog Pain Scale (VAS)
    Description
    Change in back and leg pain using Visual Analog Pain Scale score. The patient completed questionnaire is a unidimensional measure of pain intensity using a continuous scale comprised of a horizontal line 10 centimeters (100 mm) in length. The line is anchored by "no pain" (score of 0) and "worst imaginable pain". A higher score indicates greater pain intensity.
    Time Frame
    Week 2, Week 6, Month 3, Month 6, and Month 12
    Title
    Neurologic Status by Physical Exam
    Description
    Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for lower extremities, specifically reflexes, muscle strength, sensory, and straight leg raise.
    Time Frame
    Week 2, Week 6, Month 3, Month 6, and Month 12
    Title
    Success Rate
    Description
    Number of patients with secondary surgical interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or removes part of the original implant configuration with or without replacement of the components within 12 months of surgery.
    Time Frame
    Week 2, Week 6, Month 3, Month 6, and Month12
    Other Pre-specified Outcome Measures:
    Title
    Safety Endpoint - number of patients with Adverse Events
    Description
    The number of patients with Adverse Events from Screening up to Month 12 after surgery.
    Time Frame
    12 Months
    Title
    Safety Endpoint - number of patients with Serious Adverse Events
    Description
    The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
    Time Frame
    12 Months
    Title
    Safety Endpoint - number of patients with Adverse Device Effects
    Description
    The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery.
    Time Frame
    12 Months
    Title
    Safety Endpoint - number of patients with Device Related Complications
    Description
    The number of patients with any complications considered to device related with 12 months after surgery.
    Time Frame
    12 Months
    Title
    Health Economic - Duration of Surgery
    Description
    Duration of surgery in minutes.
    Time Frame
    12 Months
    Title
    Health Economic - Duration of Hospitalization
    Description
    Duration of hospital stay in days.
    Time Frame
    12 Months
    Title
    Health Economic - Return to Work
    Description
    Time to return to work in days.
    Time Frame
    12 Months
    Title
    Health Economic - Quality of Life
    Description
    Change in Quality of Life measurement using EuroQol-5D/5L scoring
    Time Frame
    12 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent. Male or female patient ≥ 18 years old. Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment. Exclusion Criteria: Requires > four-level fusion or expected to need secondary intervention within one year following surgery. To treat conditions in which general bone grafting is not advisable. In conditions where the surgical site may be subjected to excessive impact or stresses, including those beyond the load strength of fixation hardware (e.g., defect site stabilization is not possible). In case of significant vascular impairment proximal to the graft site. In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis). When intraoperative soft tissue coverage is not planned or possible. Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space. Receiving treatment with medication interfering with calcium metabolism.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pascal Longlade, MD
    Phone
    +31622210098
    Email
    pascal.longlade@kurosbio.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cesar Silva, MD
    Email
    cesar.silva@kurosbio.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    MagnetOs Putty Compared to Trinity Evolution in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

    We'll reach out to this number within 24 hrs