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redirected funding
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| Name | Class |
|---|---|
| Factory CRO | INDUSTRY |
| The London Clinic | OTHER |
| Kuros BioSciences B.V. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagnetOs Putty | Device | MagnetOs Putty has a CE-mark (2115660CE01) as well as FDA 510(k) clearance (K171563/K181958). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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 Criteria:
Per the current Instruction For Use, MagnetOs Putty must not be used in the following clinical situations:
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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Single arm, single-center, post market surveillance study.
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