Status:
WITHDRAWN
Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
Lead Sponsor:
Kuros Biosurgery AG
Collaborating Sponsors:
Factory CRO
The London Clinic
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
25-75 years
Phase:
NA
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 degene...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04128852
Start Date
November 11 2020
End Date
December 1 2023
Last Update
February 13 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.