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 range

25 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographic interbody fusion by CT scan

Timeframe: 12 months

Trial details

NCT IDNCT04128852

SponsorKuros Biosurgery AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12

View on ClinicalTrials.gov More Degenerative Disc Disease trials