MagnetOs Flex Matrix for Degenerative Disc Disease

(PRECISE Trial)

Recruiting at 4 trial locations

Overseen By Katherine Sage, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kuros Biosurgery AG

Must not be taking: Calcium metabolism drugs

Disqualifiers: Pregnancy, Bone disorders, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 1 day (surgery)

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well MagnetOs Flex Matrix (also known as MagnetOs Putty) functions as a bone graft extender for individuals with degenerative disc disease requiring spinal fusion surgery. Researchers will compare its effectiveness to another product, Trinity Elite. Participants should experience leg or back pain and require spinal fusion surgery, having tried other treatments like physical therapy or medications for at least three months without success. Those who meet these criteria may consider joining to help advance treatment options for spine issues. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future treatment options for spinal conditions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving treatment with medication that interferes with calcium metabolism.

What is the safety track record for these treatments?

Research shows that MagnetOs Flex Matrix is generally safe for spinal fusion surgeries. Studies have found a high success rate of about 95.7%, effectively helping bones heal together. It also has a low complication rate, indicating that most patients do not experience serious side effects.

Previous reviews of MagnetOs Easypack Putty, a similar product, confirm its safety and effectiveness, even without extra bone material. This suggests that MagnetOs Flex Matrix is likely safe as well.

Specific safety data for Trinity Elite is not available in the provided sources, but its approval for use in the U.S. indicates it has passed safety reviews for treating bone defects, suggesting it is generally safe for its intended use.

Overall, these findings suggest that both treatments in this study are well-tolerated and generally safe for patients undergoing spinal fusion surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

MagnetOs Flex Matrix is unique because it uses a synthetic bone graft substitute that encourages bone growth differently than traditional options. Unlike the standard treatments for degenerative disc disease, which often involve autografts or other biological materials like Trinity Elite, MagnetOs Flex Matrix uses a special surface technology that promotes bone regeneration and integration. This innovative approach is exciting for researchers because it has the potential to enhance bone healing and fusion more effectively, offering hope for improved outcomes in spinal surgeries.

What is the effectiveness track record for MagnetOs Flex Matrix in treating degenerative disc disease?

Research has shown that MagnetOs Flex Matrix, one of the treatments in this trial, effectively treats degenerative disc disease. One study found it helps bones fuse 95.7% of the time, even in patients with various health conditions. Another study reported a 92.73% fusion rate after one year, even for high-risk patients. These results suggest that MagnetOs Flex Matrix is effective in spinal fusion surgeries. It is a synthetic material mixed with a patient's own bone to support the spine. Another treatment arm in this trial uses Trinity Elite, a cryopreserved, viable cellular allograft, as a bone graft extender. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with leg and/or back pain from degenerative disc disease needing up to four-level spinal fusion surgery (T11 - S1) after failing at least 3 months of non-surgical treatments. Participants must understand and consent to the study.

Inclusion Criteria

I tried other treatments like physical therapy or medications for over 3 months without success.

Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.

I need a spine surgery for my back or leg pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants undergo up to four-level instrumented posterolateral fusion (PLF) procedure with MagnetOs Flex Matrix and Trinity Elite

1 day (surgery)

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for safety and effectiveness with follow-up visits at discharge, Week 2, Week 6, Month 3, Month 6, and Month 12

12 months

6 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and effectiveness

12 months

What Are the Treatments Tested in This Trial?

Interventions

• MagnetOs Putty

Trial Overview The study compares MagnetOs Flex Matrix, a synthetic bone graft extender, with Trinity Elite, a cellular-based allograft. Both are used in spinal fusion surgeries according to their U.S. instructions for use.

How Is the Trial Designed?

Group I: MagnetOs Flex Matrix Experimental Treatment 1 Intervention

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

Group II: Trinity Elite Active Control 1 Intervention

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)

MagnetOs Putty is already approved in United States, European Union for the following indications:

Approved in United States as MagnetOs Flex Matrix for:

• Degenerative disc disease
• Spinal fusion surgery
• Posterolateral spine fusion
• Intervertebral disc space repair

Approved in European Union as MagnetOs Flex Matrix for:

• Degenerative disc disease
• Spinal fusion surgery
• Posterolateral spine fusion

Who Is Running the Clinical Trial?

Kuros Biosurgery AG

Lead Sponsor

Trials

11

Recruited

910+

Kuros BioSciences B.V.

Industry Sponsor

Trials

5

Recruited

310+

Simplified Clinical Data Systems, LLC

Industry Sponsor

Trials

7

Recruited

300+

Published Research Related to This Trial

The ADDISC total disc replacement (TDR) design successfully mimics the natural biomechanics of a healthy intervertebral disc, allowing for physiological motion and minimizing overload on the facet joints.

In extensive testing of 10 million cycles, the ADDISC TDR demonstrated excellent durability with minimal wear (140.96 mg) and no implant failures, indicating its potential for long-term use in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ADDISC lumbar disc prosthesis: Analytical and FEA testing of novel implants. Vanaclocha, A., Vanaclocha, V., Atienza, CM., et al.[2023]

New designs for total disk replacement were tested using finite element models to see how well they can replicate the mechanical function of the intervertebral disk, which is crucial for treating low back pain.

The study found that designs with a fiber jacket around elastomers or using hydrogels effectively mimicked the non-linear behavior of the natural disk, which is important for maintaining spinal motion and protecting surrounding tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of next generation total disk replacements. van den Broek, PR., Huyghe, JM., Wilson, W., et al.[2017]

In a study involving 10 goats with induced intervertebral disc degeneration, a combination of a hydrogel and mesenchymal stem cells (MSCs) led to a significant 10% improvement in disc height and better histological conditions two weeks after treatment.

The hydrogel effectively localized to the disc area and reduced inflammation markers, suggesting that this combined therapy could be a promising approach to not only alleviate symptoms but also restore disc structure and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Hydrogel and Mesenchymal Stem Cell Therapy for Moderate-Severity Disc Degeneration in Goats. Zhang, C., Gullbrand, SE., Schaer, TP., et al.[2022]

Injecting a novel hydrogel into porcine spinal motion segments significantly restored angular stiffness and improved disc height after repeated flexion and extension, indicating its potential to enhance the mechanical integrity of degenerated intervertebral discs.

The study suggests that while the hydrogel can temporarily restore disc mechanics, continued repetitive stress can lead to a return to the original degenerated state, highlighting the need for careful management of mechanical loads post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a novel injectable hydrogel nucleus pulposus replacement in restoring the mechanical properties of cyclically fatigued porcine intervertebral discs. Balkovec, C., Vernengo, J., McGill, SM.[2016]

The study successfully developed a new surgical model to evaluate disc-like angle-ply structures (DAPS) as replacements for intervertebral discs in rats, demonstrating their stability in the spine.

DAPS showed effective cell infiltration from the surrounding area, which was enhanced by incorporating sacrificial layers, suggesting a promising approach for improving the integration of engineered disc replacements in future treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translation of an engineered nanofibrous disc-like angle-ply structure for intervertebral disc replacement in a small animal model. Martin, JT., Milby, AH., Chiaro, JA., et al.[2023]

Citations

1. neurospineproductreview.com neurospineproductreview.com/storage/products/pdfs/kuros-global-research-summary-2025.pdf

MagnetOs™ Global Research Summary - NeuroSpine Summary: This study evaluated the efficacy of MagnetOs™ Flex Matrix, i-FACTOR Putty®, OssDsign®. Catalyst Putty and FIBERGRAFT® BG Matrix in a clinically ...

2. withpower.com withpower.com/trial/phase-intervertebral-disc-degeneration-1-2021-86d36

MagnetOs Putty for Spinal Fusion (PROOF Trial) This trial is for adults over 18 with degenerative disc disease needing a two-level spinal fusion surgery, who have tried other treatments like physical therapy ...

3. kurosbio.com kurosbio.com/project-fusion/

Project Fusion Retrospective: Lumbar interbodies, 92.73% fusion rate at one year, high risk patient cohorts, MagnetOs Putty. Fusion rate of biphasic calcium phosphate bone ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878875025001159

Fusion Rate of Biphasic Calcium Phosphate Bone Graft ... This study demonstrates a high fusion rate (95.70%) and low complication rate in a diverse patient population with multiple comorbidities.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40314038/

A retrospective review of MagnetOs Easypack Putty ... This retrospective clinical study evaluates MagnetOs Easypack Putty TM as a standalone graft without autograft in interbody fusion.

6. kurosbio.com kurosbio.com/spine/flex-matrix/

MagnetOs™ Flex Matrix - Spinal Bone Graft MagnetOs™ Flex Matrix is an open fibrillar bone graft that delivers our pro-healing NeedleGrip™ surface technology for more predictable spinal fusion.

7. withpower.com withpower.com/trial/phase-intervertebral-disc-degeneration-10-2021-f06dd

MagnetOs Flex Matrix for Degenerative Disc Disease ... MagnetOs Putty will have tolerable side effects & efficacy for patients with Spinal Fusion, Sciatica, Disc Degeneration and Degenerative Disc Disease. See