Degenerative Disc DiseasePRECISENCT05037968
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
A study testing MagnetOs Flex Matrix and Trinity Elite in people with Degenerative Disc Disease and Spine Fusion, run by Kuros Biosurgery AG at 9 sites in United States.
Trial summary
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and 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, Leg Pain and/or Back Pain
- What is being tested?
- MagnetOs Flex Matrix and Trinity Elite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesUnited States
- Study dates
- 10 Jun 2024to Dec 2026
- 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 Investigational Review Board (IRB) approved informed consent.
- Male or female patient ≥ 18 years old.
- Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1)
- 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.
Who cannot join
- Requires > four-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).
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- In case of significant vascular impairment proximal to the graft site.
- In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta 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.
- Had leg pain, and/or back pain related to a benign or malignant tumor.
- Had history or presence of active malignancy.
- Has known substance abuse, psychiatric disorder, or 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
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Michigan Orthopedic Surgeons
Bloomfield Hills, Michigan, 48033
Daniel Park, MD
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Kern Singh, MD
- Recruiting
MedStar Health Research Institute
Columbia, Maryland, 21044
Addisu Mesfin, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Stephanus Viljoen, MD
- Recruiting
Inova Healthcare
Fairfax, Virginia, 22031
Andrew Fanous, MD
- Recruiting
Hartford Hospital
Hartford, Connecticut, 06106
Cameron Kia, MD
- Recruiting
Central CT Neurosurgery & Spine
New Britain, Connecticut, 06051
Ahmed Khan, MD
- Recruiting
Pinehurst Surgical Clinic
Pinehurst, North Carolina, 28374
Daniel Williams, MD
- Recruiting
Huntsman Spinal Clinic
Salt Lake City, Utah, 84124
Kade Huntsman, MD
About this study
Official title: A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOs Flex Matrix Mixed With Local Autograft Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.
In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.
Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.
Read the detailed description
In this study, following a screening period of a maximum of 30 days, 100 patients will undergo up to four-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Flex Matrix on the assigned side of the spine and Trinity Elite on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Flex Matrix will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Flex Matrix will be used as a bone graft extender mixed with autograft in a 1:1 vol% in patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Week 2, Week 6, Month 3, Month 6 and Month 12. CT-scans will only be obtained at Month 6 and Month 12.
- Being tested
- MagnetOs Flex Matrix, Trinity Elite
- Keywords
- Degenerative Disc Disease, Spine 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 Flex MatrixDevice
Procedure: Instrumented Posterolateral Lumbar Fusion
Trinity EliteDevice
Procedure: Instrumented Posterolateral Lumbar Fusion
| Study group | Role | What they receive |
|---|---|---|
| MagnetOs Flex Matrix | Experimental | MagnetOs Flex Matrix use in instrumented posterolateral fusion, 5cc-10cc mixed with local autograft bone in a 1:1 ratio per spine level at the randomized assigned side Receives: Device: MagnetOs Flex Matrix |
| Trinity Elite | Active comparator | Trinity Elite is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side. Trinity Elite will be used as a bone graft extender (mixed with local autograft) Receives: Device: Trinity Elite |
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 and 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
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. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability.
Measured: Screening, Week 2, Week 6, Month 3, Month 6, Month 12
Back and Leg Pain by Visual Analog Pain Scale (VAS)
Change in back and leg pain using Visual Analog Pain Scale score. The patient completed questionnaire is a unidimensional measure of pain intensity using a continuous scale comprised of a horizontal line 10 centimeters (100 mm) in length. The line is anchored by "no pain" (score of 0) and "worst imaginable pain". A higher score indicates greater pain intensity.
Measured: Screening, Week 2, Week 6, Month 3, Month 6, and Month 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, Week 6, Month 3, Month 6, and Month 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, Week 6, Month 3, Month 6, and Month12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start10 Jun 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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
- Parallel Assignment, Intra-patient control. Each patient serves as their own control.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuros Biosurgery AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kuros BioSciences B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037968
- Sponsor's protocol ID
- MAG-523-002
- Acronym
- PRECISE
- Status last verified
- Oct 2026
- First submitted
- 31 Aug 2021
- Last updated
- 19 Oct 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 19 Oct 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 Performance of MagnEtOs Flex Matrix Mixed With Local Autograft Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented poSterolatEral Lumbar/Thoraco-lumbar Fusion (PLF)
- ClinicalTrials.gov ID
- NCT05037968
- Acronym / sponsor ID
- PRECISE / MAG-523-002
- Keywords
- Degenerative Disc Disease, Spine Fusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kuros Biosurgery AGIndustry (pharma, biotech, devices)
- Collaborators
- Kuros BioSciences B.V.
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Sep 2021 (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 Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and undergoing spinal fusion surgery.
In this study, MagnetOs Flex Matrix will be used according to the latest U.S. Instructions For Use, specifically as a bone graft extender mixed with autograft in a 1:1 vol.% in the posterolateral spine.
Trinity Elite will also be used according to its latest IFU approved in the US. Specifically, this cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.
Detailed description
In this study, following a screening period of a maximum of 30 days, 100 patients will undergo up to four-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Flex Matrix on the assigned side of the spine and Trinity Elite on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Flex Matrix will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Flex Matrix will be used as a bone graft extender mixed with autograft in a 1:1 vol% in patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.
Radiographs will be obtained at Screening, Week 2, Week 6, 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
- Parallel Assignment, Intra-patient control. Each patient serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| MagnetOs Flex Matrix | Experimental | Device: MagnetOs Flex MatrixMagnetOs Flex Matrix use in instrumented posterolateral fusion, 5cc-10cc mixed with local autograft bone in a 1:1 ratio per spine level at the randomized assigned side |
| Trinity Elite | Active comparator | Device: Trinity EliteTrinity Elite is a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side. Trinity Elite will be used as a bone graft extender (mixed with local autograft) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
- Male or female patient ≥ 18 years old.
- Patients with leg pain, and/or back pain requiring up to four-level instrumented posterolateral lumbar/thoraco-lumbar fusion (T11 - S1)
- 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.
Key exclusion criteria (16 listed)
- Requires > four-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 Flex MatrixProcedure: Instrumented Posterolateral Lumbar Fusion | Device | MagnetOs Flex Matrix |
| Trinity EliteProcedure: Instrumented Posterolateral Lumbar Fusion | Device | Trinity Elite |
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 and Month 12
Radiographic Fusion by CT Scan
Time frame: Month 6
Functional Outcome by Oswestry Disability Index
Time frame: Screening, Week 2, Week 6, Month 3, Month 6, Month 12
Back and Leg Pain by Visual Analog Pain Scale (VAS)
Time frame: Screening, Week 2, Week 6, Month 3, Month 6, and Month 12
Neurologic Status by Physical Exam
Time frame: Screening, Week 2, Week 6, Month 3, Month 6, and Month 12
Success Rate
Time frame: Week 2, Week 6, Month 3, Month 6, and Month12
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 19 Oct 2026.
- Individual participant dataSharing planned: No
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagnetOs Flex Matrix and Trinity Elite in people with Degenerative Disc Disease and Spine Fusion, run by Kuros Biosurgery AG at 9 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 4 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 (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 19 Oct 2026.