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

NCT ID: NCT04128852

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-11
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MagnetOs Putty

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.

Group Type: OTHER

MagnetOs Putty

Intervention Type: DEVICE

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

Interventions

MagnetOs Putty

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Factory CRO

INDUSTRY

Sponsor Role: collaborator

The London Clinic

OTHER

Sponsor Role: collaborator

Kuros BioSciences B.V.

INDUSTRY

Sponsor Role: collaborator

Kuros Biosurgery AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MAG-919-013

Identifier Type: -

Identifier Source: org_study_id