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Post Marketing Study of MagnetOs Putty Compared to Autograft in Patients Undergoing Posterolateral Lumbar Fusion (PROOF)

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ClinicalTrials.gov Identifier: NCT04679844
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : July 9, 2021
Sponsor:
Collaborators:
Kuros BioSciences B.V.
Simplified Clinical Data Systems, LLC
Henry Ford Health System
Information provided by (Responsible Party):
Kuros Biosurgery AG

Tracking Information
First Submitted Date  ICMJE December 18, 2020
First Posted Date  ICMJE December 22, 2020
Last Update Posted Date July 9, 2021
Actual Study Start Date  ICMJE February 4, 2021
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2020)
Radiographic Fusion by CT Scan [ Time Frame: Month 12 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2021)
  • Radiographic Fusion by Plain Radiographs [ Time Frame: Week 6, Month 3, Month 9 ]
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
  • Radiographic Fusion by CT Scan [ Time Frame: Month 6 ]
    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 Questionnaire [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
    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 in those rehabilitating from low back pain. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability or bedridden.
  • Back and Leg Pain by Visual Analog Pain Scale Questionnaire [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
    Change in back and leg pain using Visual Analog Pain Scale (0-100). Patient-completed questionnaire scoring pain by using 100 mm line. Zero being no pain, 100 is worst pain imaginable.
  • Neurologic Status by Physical Exam [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
    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 [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 18, 2020)
  • Radiographic Fusion by Plain Radiographs [ Time Frame: Week 6, Month 3, Month 9 ]
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
  • Radiographic Fusion by CT Scan [ Time Frame: Month 6 ]
    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 (ODI) [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
    Functional outcome by the Oswestry Disability Index (ODI) questionnaire.
  • Back and Leg Pain by Visual Analog Scale (VAS) [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
    Change in back and leg pain using VAS scoring.
  • Neurologic Status by Exam [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
    Change in neurologic status by examination to document stable, improved, or deficits in condition.
  • Success Rate [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
    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.
Current Other Pre-specified Outcome Measures
 (submitted: December 18, 2020)
  • Safety Endpoint - number of patients with Adverse Events [ Time Frame: 12 Months ]
    The number of patients with Adverse Events from Screening up to Month 12 after surgery.
  • Safety Endpoint - number of patients with Serious Adverse Events [ Time Frame: 12 Months ]
    The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
  • Safety Endpoint - number of patients with Adverse Device Effects [ Time Frame: 12 Months ]
    The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery.
  • Safety Endpoint - number of patients with Device Related Complications [ Time Frame: 12 Months ]
    The number of patients with any complications considered to device related with 12 months after surgery.
  • Health Economic - Duration of Surgery [ Time Frame: 12 Months ]
    Duration of surgery in minutes.
  • Health Economic - Duration of Hospitalization [ Time Frame: 12 Months ]
    Duration of hospital stay in days.
  • Health Economic - Return to Work [ Time Frame: 12 Months ]
    Time to return to work in days.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Post Marketing Study of MagnetOs Putty Compared to Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Official Title  ICMJE A Prospective, Randomized, Single-Center Study to Assess the Safety and Performance of MagnetOs Putty Compared to Autograft in Patients Undergoing Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)
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.

Detailed Description

In this study, following a screening period of a maximum of 30 days, 30 patients will undergo a two-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 autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, Month 9, 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 two-level degenerative disc disease with up to grade 1 spondylolisthesis requiring treatment with an instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.

Radiographs will be obtained at Screening, Day 0, Week 6, Month 3, and Month 9. CT scans will only be obtained at Month 6 and Month 12.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Intra-patient control. Each patient serves as their own control.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Degenerative Disc Disease
  • Spine Fusion
Intervention  ICMJE
  • Device: MagnetOs Putty
    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.
  • Device: Autograft Bone
    Autologous bone graft used in instrumented posterolateral fusion, 7cc-10cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.
Study Arms  ICMJE
  • Experimental: MagnetOs Putty

    Interventions

    • Procedure: Instrumented posterolateral spine fusion
    • Device; MagnetOs Putty
    Intervention: Device: MagnetOs Putty
  • Active Comparator: Autograft Bone

    Interventions

    • Procedure: Instrumented posterolateral spine fusion
    • Device: Autologous bone graft
    Intervention: Device: Autograft Bone
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, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2023
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.
  • Male or female patient ≥ 18 years old.
  • Patients with degenerative disc disease with spondylolisthesis or spinal stenosis, leg pain, and/or back pain and requiring two-level instrumented posterolateral lumbar/thoracolumbar fusion (T11 - S1). Degenerative disc disease is defined by the presence of one or more of the following:

    1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
    2. osteophyte formation of facet joints or vertebral endplates,
    3. decreased disc height by > 2 mm, but dependent upon the spinal level,
    4. scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
    5. disc degeneration and/or herniation,
    6. facet degeneration,
    7. vacuum phenomenon.
  • 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 < two-level fusion or expected to need secondary intervention within one year following surgery.
  • Had prior PLF fusion or attempted PLF fusion at the involved levels.
  • Had previous decompression at the involved levels.
  • Women who are or intend to become pregnant within the next 12 months.
  • 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.
  • Has degenerative disc disease (DDD) related to a benign or malignant tumor.
  • Has history or presence of active malignancy.
  • Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
  • Is involved in active litigation relating to his/her spinal condition.
  • Has participated in an investigational study within 30 days prior to surgery for study devices.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pascal Longlade +31 (0)6 2221 00 98 pascal.longlade@kurosbio.com
Contact: Trai curtis trai.curtis@kurosbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04679844
Other Study ID Numbers  ICMJE MAG-920-023
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kuros Biosurgery AG
Study Sponsor  ICMJE Kuros Biosurgery AG
Collaborators  ICMJE
  • Kuros BioSciences B.V.
  • Simplified Clinical Data Systems, LLC
  • Henry Ford Health System
Investigators  ICMJE
Study Director: Pascal Longlade Kuros BioSciences B.V.
PRS Account Kuros Biosurgery AG
Verification Date July 2021

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