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

Degenerative Disc Disease Clinical Trial

— PROGRESS  

Official title:

A Prospective, Single Arm, Single-center Study to Assess the Safety and Performance of MagnetOs Putty in Patients Undergoing Single/Two-level Lateral Lumbar Interbody Fusion

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04128852
• Other study ID #: MAG-919-013
• Status: Withdrawn
• Phase: N/A
• Start date: November 11, 2020
• Est. completion date: December 2023

Study information

• Verified date: February 2024
• Source: Kuros Biosurgery AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Written informed consent by the patient.

2. Male or female patient = 25 up to and including 75 years old.

3. 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:

1. instability (angulation = 5 degrees or translation = 3 mm on flexion/extension radiographs),

2. osteophyte formation of facet joints or vertebral endplates,

3. decreased disc height by > 2 mm, but dependent upon the spinal level,

4. scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,

5. disc degeneration and/or herniation,

6. facet degeneration,

7. vacuum phenomenon.

4. Patients with an Oswestry Disability Index (ODI) score = 30.

5. Patients with a Visual Analogue Scale (VAS) leg score = 40.

6. 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:

1. To treat conditions in which general bone grafting is not advisable.

2. 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).

3. In case of significant vascular impairment proximal to the graft site.

4. In case of severe metabolic or systemic bone disorders that affect bone or wound healing.

5. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).

6. When intraoperative soft tissue coverage is not planned or possible.

7. In direct contact with the articular space.

8. In case of treatment with medication interfering with the calcium metabolism.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Kuros Biosurgery AG	Factory CRO, Kuros BioSciences B.V., The London Clinic

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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