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MagnetOs Flex Matrix Compared to Cell Based Allografts in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion (PRECISE)

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ClinicalTrials.gov Identifier: NCT05037968
Recruitment Status : Not yet recruiting
First Posted : September 8, 2021
Last Update Posted : April 11, 2024
Sponsor:
Collaborator:
Simplified Clinical Data Systems, LLC
Information provided by (Responsible Party):
Kuros Biosurgery AG

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix 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 Flex Matrix 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.

A cellular based allograft will also be used according to its latest IFU approved in the US. Specifically, the cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.


Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spine Fusion Leg Pain and/or Back Pain Device: MagnetOs Flex Matrix Not Applicable

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 Flex Matrix on the assigned side of the spine and a Cell Based Allograft on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, 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 Flex Matrix will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Flex Matrix 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 2, Week 6, Month 3, Month 6 and Month 12. CT-scans will only be obtained at Month 6 and Month 12.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment, Intra-patient control. Each patient serves as their own control.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOsTM Flex Matrix Compared to Cell Based Allograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
Estimated Study Start Date : June 2024
Estimated Primary Completion Date : July 2025
Estimated Study Completion Date : July 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: MagnetOs Flex Matrix
MagnetOs Flex Matrix use in instrumented posterolateral fusion, 5cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side
 Device: MagnetOs Flex Matrix
Procedure: Instrumented Posterolateral Lumbar Fusion
Active Comparator: Cell Based Allograft
Cellular Allografts are a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side.
 Device: MagnetOs Flex Matrix
Procedure: Instrumented Posterolateral Lumbar Fusion


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Radiographic Fusion by Plain Radiographs [ Time Frame: Week 2, Week 6, Month 3 ]
    The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.

  2. 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.

  3. Functional Outcome by Oswestry Disability Index [ Time Frame: Week 2, Week 6, Month 3, Month 6, Month 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. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability.

  4. Back and Leg Pain by Visual Analog Pain Scale (VAS) [ Time Frame: Week 2, Week 6, Month 3, Month 6, and Month 12 ]
    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.

  5. Neurologic Status by Physical Exam [ Time Frame: Week 2, Week 6, Month 3, Month 6, and Month 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.

  6. Success Rate [ Time Frame: Week 2, Week 6, Month 3, Month 6, and Month12 ]
    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.


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. Health Economic - Duration of Surgery [ Time Frame: 12 Months ]
    Duration of surgery in minutes.

  6. Health Economic - Duration of Hospitalization [ Time Frame: 12 Months ]
    Duration of hospital stay in days.

  7. Health Economic - Return to Work [ Time Frame: 12 Months ]
    Time to return to work in days.

  8. Health Economic - Quality of Life [ Time Frame: 12 Months ]
    Change in Quality of Life measurement using EuroQol-5D/5L scoring


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037968


Contacts
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Contact: Katherine Sage, DO 617 285 2489 katherine.sage@kurosbio.com
Contact: Cesar Silva, MD cesar.silva@kurosbio.com

Sponsors and Collaborators
Kuros Biosurgery AG
Simplified Clinical Data Systems, LLC
More Information
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Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT05037968    
Other Study ID Numbers: CT-003
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: April 11, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Kuros Biosurgery AG:
Degenerative Disc Disease
Spine Fusion
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases