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Completed

NCT Number: NCT04679896

Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases Spine Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 three-level instrumented posterolateral lumbar fusion (L2 - 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 > three-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.
  • Women who are or intend to become pregnant within the next 12 months.

Treatment and study plan

MagnetOs Putty

Device

Procedure: Instrumented posterolateral spine fusion

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kuros Biosurgery AG

Industry

Collaborators

  • Orthopaedic Institute of Western Kentucky
  • Simplified Clinical Data Systems, LLC

Registry information

Official study 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).

Acronym: PARTNER

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 22, 2020
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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