RECRUITING

Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed with Autograft in Patients Undergoing Posterolateral Lumbar Fusion

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Conditions

Degenerative Disc DiseaseSpine FusionBack Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.

Official Title

A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed with Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)

Quick Facts

Study Start:2024-12-06
Study Completion:2027-08-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04679844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.
  2. * Male or female patient ≥ 18 years old.
  3. * Patients with segmental mechanical spinal instability requiring arthrodesis surgery.
  4. 1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
  5. 2. decreased disc height by \> 2 mm, but dependent upon the spinal level
  6. 3. Grade II or more listhesis
  7. 4. TLICS equal or greater than 5
  8. 5. Unstable burst fracture
  9. * 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 (if the patient undergoes elective surgery). Patients who have spinal instability (as defined above in inclusion criteria number three), caused by acute trauma requiring urgent surgical treatment are excluded from this criterion.
  1. * Requires \> two-level fusion or expected to need secondary intervention within one year following surgery.
  2. * Had prior PLF fusion or attempted PLF fusion at the involved levels.
  3. * Had previous decompression at the involved levels.
  4. * Women who are or intend to become pregnant within the next 12 months.
  5. * To treat conditions in which general bone grafting is not advisable.
  6. * 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).
  7. * In case of significant vascular impairment proximal to the graft site.
  8. * In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta, history of or active Pott's disease, stage \>4 renal disease or Paget's Disease) that affect bone or wound healing.
  9. * In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
  10. * When intraoperative soft tissue coverage is not planned or possible.
  11. * Receiving treatment with medication interfering with calcium metabolism.
  12. * Has degenerative disc disease (DDD) related to a benign or malignant tumor.
  13. * Has history or presence of active malignancy.
  14. * 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.
  15. * Is involved in active litigation relating to his/her spinal condition.
  16. * Has participated in an investigational study within 30 days prior to surgery for study devices.

Contacts and Locations

Study Contact

Katherine Sage, DO
CONTACT
617 285 2489
Katherine.Sage@kurosbio.com
Cesar Silva, MD
CONTACT
9702156793
Cesar.silva@kurosbio.com

Principal Investigator

Katherine Sage, DO
STUDY_DIRECTOR
Kuros BioSciences B.V.

Study Locations (Sites)

Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37209
United States
University of Washington
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Kuros Biosurgery AG

  • Katherine Sage, DO, STUDY_DIRECTOR, Kuros BioSciences B.V.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-06
Study Completion Date2027-08-30

Study Record Updates

Study Start Date2024-12-06
Study Completion Date2027-08-30

Terms related to this study

Keywords Provided by Researchers

  • Degenerative Disc Disease
  • Spine Fusion

Additional Relevant MeSH Terms

  • Degenerative Disc Disease
  • Spine Fusion
  • Back Pain