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Trial record 1 of 1 for:    NCT04679896
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Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion (PARTNER)

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ClinicalTrials.gov Identifier: NCT04679896
Recruitment Status : Recruiting
First Posted : December 22, 2020
Last Update Posted : September 1, 2021
Sponsor:
Collaborators:
Orthopaedic Institute of Western Kentucky
Simplified Clinical Data Systems, LLC
Information provided by (Responsible Party):
Kuros Biosurgery AG

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 leg pain and/or back pain 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.


Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Spine Fusion Device: MagnetOs Putty Not Applicable

Detailed Description:

In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to a three-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 local autograft bone 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 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 with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar 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. CT scans will only be obtained at Month 6 and Month 12.

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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, Single-center Study to Assess the Performance of MagnetOs Putty Compared to Local Autograft in Patients Undergoing up to Three-level Instrumented Posterolateral Lumbar Fusion (PLF).
Actual Study Start Date : August 13, 2021
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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: MagnetOs Putty
Procedure: Instrumented posterolateral spine fusion

Local autograft Device: MagnetOs Putty
Procedure: Instrumented posterolateral spine fusion




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 fusion assessed by plain radiographs

  2. Posterolateral lumbar fusion assessed by CT-scan [ Time Frame: Month 6 ]
    The rate of posterolateral lumbar 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. Interbody lumbar fusion assessed by plain radiographs [ Time Frame: Week 2, Week 6, Month 3, Month 6, Month 12 ]
    The rate of interbody lumbar fusion assessed by plain radiographs at Week 2, Week 6, Month 3, Month 6, and Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior vertebral bodies

  4. Functional Outcome by Oswestry Disability Index [ Time Frame: Week 2, Week 6, Month 3, 6, and 12 ]
    Change in functional score using Oswestry Disability Index questionnaire. Patient-completed survey provides subjective percentage score for level of function (disability) in activities of daily living. Score rage 0-100 percent. The lower the percentages indicate higher functionality; 0-20% minimal disability, 80-100% significant disability.

  5. General, back and Leg Pain by Visual Analog Pain Scale [ Time Frame: Week 2, Week 6, Month 3, 6, and 12 ]
    Change in general, 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.

  6. Neurologic Status by Physical Exam [ Time Frame: Week 2, Week 6, Month 3, 6, and 12 ]
    Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for the lower extremities, specifically in reflexes, muscle strength, sensory, and straight leg raise.

  7. Success Rate [ Time Frame: Week 2, Week 6, Month 3, 6, 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


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: Week 6, Month 3, 6, and 12 ]
    Change in Quality of Life measurement using EuroQol 5D/5L scoring



Information from the National Library of Medicine

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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:

  1. Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
  2. Male or female patient ≥ 18 years old.
  3. Patients with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion (L2 - S1).
  4. 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:

  1. Requires > three-level fusion or expected to need secondary intervention within one year following surgery.
  2. To treat conditions in which general bone grafting is not advisable.
  3. 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).
  4. In case of significant vascular impairment proximal to the graft site.
  5. In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
  6. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
  7. When intraoperative soft tissue coverage is not planned or possible.
  8. Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
  9. Receiving treatment with medication interfering with calcium metabolism.
  10. Women who are or intend to become pregnant within the next 12 months.

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): NCT04679896


Contacts
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Contact: Pascal Longlade, MD +31622210098 pascal.longlade@kurosbio.com
Contact: Cesar Silva, MD cesar.silva@kurosbio.com

Locations
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United States, Kentucky
Orthopaedic Institute of Western Kentucky Recruiting
Paducah, Kentucky, United States, 42001
Contact: Brandon Strenge, MD         
Sponsors and Collaborators
Kuros Biosurgery AG
Orthopaedic Institute of Western Kentucky
Simplified Clinical Data Systems, LLC
Investigators
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Study Director: Pascal Longlade, MD Kuros BioSciences B.V.
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Responsible Party: Kuros Biosurgery AG
ClinicalTrials.gov Identifier: NCT04679896    
Other Study ID Numbers: MAG-920-059
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: September 1, 2021
Last Verified: August 2021
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: Yes
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