Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease

NCT04128852 | Withdrawn

• 1 other identifier: MAG-919-013
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a post-marketing clinical follow-up study for MagnetOs Putty. MagnetOs Putty is a synthetic bone-like material which is routinely used by surgeons as a treatment for patients with degenerative disc disease who will undergo surgery for spinal fusion (extreme lateral interbody fusion (XLIF). MagnetOs Putty will be used according to the instructions for use.

Conditions

Degenerative Disc Disease

Keywords

Spinal Fusion

Outcome Measures

Primary Outcomes (1)

• Radiographic interbody fusion by CT scan

  The rate of interbody fusion assessed by CT-scan at Month 12. Radiographic fusion using CT-scan will be defined by an independent radiology expert at Month 12 post-surgery and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body.

  12 months

Study Arms (1)

MagnetOs Putty

OTHER

MagnetOs Putty will be applied according to the latest Instructions For Use (IFU) approved in Europe. Specifically, MagnetOs Putty will be used as bone void filler.

Device: MagnetOs Putty

Interventions

MagnetOs Putty DEVICE

MagnetOs Putty has a CE-mark (2115660CE01) as well as FDA 510(k) clearance (K171563/K181958).

MagnetOs Putty

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent by the patient.
• Male or female patient ≥ 25 up to and including 75 years old.
• Patients with degenerative disc disease with up to grade 1 spondylolisthesis and with leg pain requiring 1 to 3 level laminectomy and a single/two-level fusion (L2 - S1). Degenerative disc disease is defined by the presence of one or more of the following:
• instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
• osteophyte formation of facet joints or vertebral endplates,
• decreased disc height by \> 2 mm, but dependent upon the spinal level,
• scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
• disc degeneration and/or herniation,
• facet degeneration,
• vacuum phenomenon.
• Patients with an Oswestry Disability Index (ODI) score ≥ 30.
• Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
• Failed conservative treatment (physical therapy, bed rest, medications, spinal injections or transcutaneous electrical nerve stimulation) for a period of 6 months prior to study enrollment.

You may not qualify if:

• Per the current Instruction For Use, MagnetOs Putty must not be used in the following clinical situations:
• 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 stabilisation is not possible).
• In case of significant vascular impairment proximal to the graft site.
• In case of severe metabolic or systemic bone disorders 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.
• In direct contact with the articular space.
• In case of treatment with medication interfering with the calcium metabolism.

Sponsors & Collaborators

• Kuros Biosurgery AG: lead
• Factory CRO: collaborator
• The London Clinic: collaborator
• Kuros BioSciences B.V.: collaborator

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, single-center, post market surveillance study.

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 16, 2019
• Study Start: November 11, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share