Degenerative Disc DiseasePROGRESSNCT04128852
Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
A study testing MagnetOs Putty in people with Degenerative Disc Disease, run by Kuros Biosurgery AG.
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). Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- MagnetOs Putty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2020to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 13Show fewer
- scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
- disc degeneration and/or herniation,
- facet degeneration,
- vacuum phenomenon.
- 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.
Who cannot join
- Per the current Instruction For Use, MagnetOs Putty must not be used in the following clinical situations:
- 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.
- In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
Show all 9Show fewer
- When intraoperative soft tissue coverage is not planned or possible.
- In direct contact with the articular space.
- In case of treatment with medication interfering with the calcium metabolism.
About this study
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
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
- Being tested
- MagnetOs Putty
- Keywords
- Spinal Fusion
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetOs PuttyDevice
MagnetOs Putty has a CE-mark (2115660CE01) as well as FDA 510(k) clearance (K171563/K181958).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MagnetOs Putty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start11 Nov 2020
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: redirected funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, single-center, post market surveillance study.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Factory CRO, The London Clinic, Kuros BioSciences B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128852
- Sponsor's protocol ID
- MAG-919-013
- Acronym
- PROGRESS
- Status last verified
- Feb 2024
- First submitted
- 4 Oct 2019
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04128852
- Acronym / sponsor ID
- PROGRESS / MAG-919-013
- Conditions
- Degenerative Disc Disease
- Keywords
- Spinal Fusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: redirected funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Collaborators
- Factory CRO, The London Clinic, Kuros BioSciences B.V.
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, single-center, post market surveillance study.
| Arm | Type | Receives |
|---|---|---|
| MagnetOs Putty | Other | Device: MagnetOs PuttyMagnetOs 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. |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (9 listed)
- Per the current Instruction For Use, MagnetOs Putty must not be used in the following clinical situations:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagnetOs PuttyMagnetOs Putty has a CE-mark (2115660CE01) as well as FDA 510(k) clearance (K171563/K181958). | Device | MagnetOs Putty |
Primary outcome
Radiographic interbody fusion by CT scan
Time frame: 12 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Degenerative Disc Disease
Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MagnetOs Putty in people with Degenerative Disc Disease, run by Kuros Biosurgery AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic interbody fusion by CT scan (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.