Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Dis… (NCT04128852) | Clinical Trial Compass
WithdrawnNot Applicable
Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
Stopped: redirected funding
0Started 2020-11-11
Plain-language 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.
Who can participate
Age range25 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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,
Exclusion criteria
✕. 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.