Degenerative Disc DiseasePROOFNCT04679844
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
A study testing MagnetOs Easypack Putty and Demineralized Bone Matrix or Fibers mixed with local autograft bone in people with Degenerative Disc Disease and Spine Fusion, run by Kuros Biosurgery AG at 6 sites in United States.
Trial summary
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Degenerative Disc Disease, Spine Fusion, Back Pain
- What is being tested?
- MagnetOs Easypack Putty and Demineralized Bone Matrix or Fibers mixed with local autograft bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 6 Dec 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.
- Male or female patient ≥ 18 years old.
- Patients with segmental mechanical spinal instability requiring arthrodesis surgery.
- Instability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of one or more of the following:
- instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
- decreased disc height by > 2 mm, but dependent upon the spinal level
Show all 10Show fewer
- Grade II or more listhesis
- TLICS equal or greater than 5
- Unstable burst fracture
- Failed conservative treatment (physical therapy, bed rest, medications, spinal injections, manipulations, or transcutaneous electrical nerve stimulation) for a minimum period of 3 months prior to study enrollment (if the patient undergoes elective surgery). Patients who have spinal instability (as defined above in inclusion criteria number three), caused by acute trauma requiring urgent surgical treatment are excluded from this criterion.
Who cannot join
- Requires > two-level fusion or expected to need secondary intervention within one year following surgery.
- Had prior PLF fusion or attempted PLF fusion at the involved levels.
- Had previous decompression at the involved levels.
- Women who are or intend to become pregnant within the next 12 months.
- 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 stabilization is not possible).
Show all 16Show fewer
- In case of significant vascular impairment proximal to the graft site.
- In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta, history of or active Pott's disease, stage >4 renal disease or Paget's Disease) 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).
- When intraoperative soft tissue coverage is not planned or possible.
- Receiving treatment with medication interfering with calcium metabolism.
- Has degenerative disc disease (DDD) related to a benign or malignant tumor.
- Has history or presence of active malignancy.
- Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
- Is involved in active litigation relating to his/her spinal condition.
- Has participated in an investigational study within 30 days prior to surgery for study devices.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Corewell Health
Grand Rapids, Michigan, 49503
Jason Squires, M, Jason.Squires@corewellhealth.org
- Recruiting
The Regents of the University of California- Irvine Campus
Irvine, California, 92697
Michael Oh, MD, ohm2@hs.uci.edu
- Recruiting
Tennessee Orthopaedic Alliance
Nashville, Tennessee, 37209
Ryan Snowden, MD
- Recruiting
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
Principal Investigator, Jose Canseco, MD
- Recruiting
University of Washington
Seattle, Washington, 98104
Christoph Hofstetter, MD
- Recruiting
The Washington University
St Louis, Missouri, 63130
Principal Investigator, Mark Lambrechts, MD
About this study
Official title: A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery.
In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.
Read the detailed description
In this study, following a screening period of a maximum of 30 days, 60 patients will undergo up to two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Easypack Putty standalone on the assigned side of the spine and Demineralized Bone Matrix or Fibers mixed with local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Month 3, Month 6, and Month 12. An interim analysis will be performed once 30 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Easypack Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Easypack Putty will be used standalone in patients up to two-level degenerative disc disease with segmental mechanical spinal instability requiring treatment with an instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Discharge, Month 3, Month 6 and Month 12. CT scans will only be obtained at Month 6 and Month 12.
- Conditions
- Degenerative Disc Disease, Spine Fusion, Back Pain
- Being tested
- MagnetOs Easypack Putty, Demineralized Bone Matrix or Fibers mixed with local autograft bone
- Keywords
- Degenerative Disc Disease, Spine Fusion
- Medical subject headings
- Intervertebral Disc Degeneration, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnetOs Easypack PuttyDevice
MagnetOs Easypack Putty used standalone in instrumented posterolateral fusion, 5cc-15c per spine level at the randomized assigned side.
Demineralized Bone Matrix or Fibers mixed with local autograft boneDevice
Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed in a 1:1 vol% with local autologous bone graft used in instrumented posterolateral fusion, 5cc-15cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| MagnetOs Easypack Putty | Experimental | Interventions
* Procedure: Instrumented posterolateral spine fusion
* Device; MagnetOs Easypack Putty Receives: Device: MagnetOs Easypack Putty |
| Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone | Active comparator | Interventions
* Procedure: Instrumented posterolateral spine fusion
* Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone Receives: Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Fusion by CT Scan
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
Measured: Month 12
Secondary outcomes (6)
Radiographic Fusion by Plain Radiographs
The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
Measured: Month 6, Month 12
Radiographic Fusion by CT Scan
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 6. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
Measured: Month 6
Functional Outcome by Oswestry Disability Index Questionnaire
Functional outcome by the Oswestry Disability Index questionnaire. Patient-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living in those rehabilitating from low back pain. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability or bedridden.
Measured: Screening, Week 2, Month 3, 6, and 12
Back and Leg Pain by Visual Analog Pain Scale Questionnaire
Change in back and leg pain using Visual Analog Pain Scale (0-100). Patient-completed questionnaire scoring pain by using 100 mm line. Zero being no pain, 100 is worst pain imaginable.
Measured: Screening, Week 2, Month 3, 6, and 12
Neurologic Status by Physical Exam
Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for lower extremities, specifically reflexes, muscle strength, sensory, and straight leg raise.
Measured: Screening, Week 2, Month 3, 6, and 12
Success Rate
Number of patients with secondary surgical interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, or any other procedure that adjusts or removes part of the original implant configuration with or without replacement of the components within 12 months of surgery.
Measured: Week 2, Month 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start6 Dec 2024
- Primary completion2 Jun 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intra-patient control. Each patient serves as their own control.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simplified Clinical Data Systems, LLC, Kuros BioSciences B.V.
- Responsible party
- Sponsor
- Investigators
- Cesar Silva, MD, Study director, Kuros BioSciences B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679844
- Sponsor's protocol ID
- MAG-920-023
- Acronym
- PROOF
- Status last verified
- Nov 2025
- First submitted
- 18 Dec 2020
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center Study to Assess the Safety and Performance of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers (DBX or Grafton) Mixed With Local Autograft in Patients Undergoing One to Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)
- ClinicalTrials.gov ID
- NCT04679844
- Acronym / sponsor ID
- PROOF / MAG-920-023
- Conditions
- Degenerative Disc Disease, Spine Fusion, Back Pain
- Keywords
- Degenerative Disc Disease, Spine Fusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Collaborators
- Simplified Clinical Data Systems, LLC, Kuros BioSciences B.V.
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 22 Dec 2020 (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 is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease or spinal trauma undergoing spinal fusion surgery.
In this study, MagnetOs Easypack Putty will be used according to the latest U.S. Instructions For Use, standalone in the posterolateral spine.
Detailed description
In this study, following a screening period of a maximum of 30 days, 60 patients will undergo up to two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Easypack Putty standalone on the assigned side of the spine and Demineralized Bone Matrix or Fibers mixed with local autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Month 3, Month 6, and Month 12. An interim analysis will be performed once 30 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Easypack Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Easypack Putty will be used standalone in patients up to two-level degenerative disc disease with segmental mechanical spinal instability requiring treatment with an instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Discharge, Month 3, Month 6 and Month 12. CT scans will only be obtained at Month 6 and Month 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intra-patient control. Each patient serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| MagnetOs Easypack Putty | Experimental | Device: MagnetOs Easypack PuttyInterventions * Procedure: Instrumented posterolateral spine fusion * Device; MagnetOs Easypack Putty |
| Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone | Active comparator | Device: Demineralized Bone Matrix or Fibers mixed with local autograft boneInterventions * Procedure: Instrumented posterolateral spine fusion * Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.
- Male or female patient ≥ 18 years old.
- Patients with segmental mechanical spinal instability requiring arthrodesis surgery.
- Instability can be either caused by degenerative disc disease or by traumatic injury to the spinal column. Patient requiring a maximum of two-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1) will be enrolled. Mechanical instability is defined by the presence of one or more of the following:
- instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
Key exclusion criteria (16 listed)
- Requires > two-level fusion or expected to need secondary intervention within one year following surgery.
- Had prior PLF fusion or attempted PLF fusion at the involved levels.
- Had previous decompression at the involved levels.
- Women who are or intend to become pregnant within the next 12 months.
- To treat conditions in which general bone grafting is not advisable.
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 Easypack PuttyMagnetOs Easypack Putty used standalone in instrumented posterolateral fusion, 5cc-15c per spine level at the randomized assigned side. | Device | MagnetOs Easypack Putty |
| Demineralized Bone Matrix or Fibers mixed with local autograft boneDemineralized Bone Matrix or Fibers (DBX or Grafton) mixed in a 1:1 vol% with local autologous bone graft used in instrumented posterolateral fusion, 5cc-15cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side. | Device | Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone |
Primary outcome
Radiographic Fusion by CT Scan
Time frame: Month 12
The rate of posterolateral lumbar/thoracolumbar fusion assessed by CT-scan at Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior transverse processes.
6 secondary outcomes
Radiographic Fusion by Plain Radiographs
Time frame: Month 6, Month 12
Radiographic Fusion by CT Scan
Time frame: Month 6
Functional Outcome by Oswestry Disability Index Questionnaire
Time frame: Screening, Week 2, Month 3, 6, and 12
Back and Leg Pain by Visual Analog Pain Scale Questionnaire
Time frame: Screening, Week 2, Month 3, 6, and 12
Neurologic Status by Physical Exam
Time frame: Screening, Week 2, Month 3, 6, and 12
Success Rate
Time frame: Week 2, Month 3, 6, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Degenerative Disc Disease
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
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
RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
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.
Cesar Silva, MD study director
Kuros BioSciences B.V.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagnetOs Easypack Putty and Demineralized Bone Matrix or Fibers mixed with local autograft bone in people with Degenerative Disc Disease and Spine Fusion, run by Kuros Biosurgery AG at 6 sites in United States.
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 10 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cesar Silva, MD (9702156793, cesar.silva@kurosbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Fusion by CT Scan (time frame: Month 12). 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 20 Mar 2026.