MagnetOs Putty for Spinal Fusion

(PROOF Trial)

Recruiting at 5 trial locations

Overseen By Philippe Saudan

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)

Compensation: Varies

Number of Visits: Unknown

Duration: Surgery and immediate recovery

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new use of MagnetOs Easypack Putty, a synthetic product used in spinal fusion surgeries. The goal is to assess its effectiveness in helping people with spinal instability due to conditions like degenerative disc disease or spinal injuries. The trial compares MagnetOs Putty to traditional bone graft methods, which use a patient's own bone (known as autograft bone). Suitable candidates have mechanical spinal instability (backbone problems causing movement) and have not found success with other treatments like physical therapy. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

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 MagnetOs Putty?

Research has shown that MagnetOs Easypack Putty is safe for use in spinal fusion surgeries. One study demonstrated a 94.4% success rate in bone fusion, indicating its effectiveness and safety in the body. Additionally, patients have experienced high success rates and good safety outcomes when the putty is used alone, without additional bone grafts. This evidence suggests that MagnetOs Putty is well-tolerated by patients undergoing spinal fusion procedures. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

MagnetOs Putty is unique because it offers a synthetic alternative to traditional bone grafts used in spinal fusion procedures. Unlike standard treatments that rely on autograft bone, which involves harvesting bone from the patient’s own body, MagnetOs Putty is a synthetic biomaterial that mimics the natural bone regeneration process. This innovative putty is designed to promote bone growth by enhancing the body's natural healing mechanisms, potentially reducing the need for additional surgeries and the associated risks of harvesting bone from the patient. Researchers are excited about this treatment because it could simplify spinal fusion surgeries and improve patient outcomes by providing a more efficient and less invasive option.

What is the effectiveness track record for MagnetOs Putty in spinal fusion surgery?

Studies have shown that MagnetOs Easypack Putty, a treatment in this trial, works well for spinal fusion. One study found that it helps bones grow and join in the spine, providing consistent results. Research shows that this putty, used alone without extra bone material, can successfully support spinal fusion surgeries. Surgeons trust its ability to deliver reliable outcomes, making it a valuable choice for spinal fusion surgery. Another treatment arm in this trial uses Demineralized Bone Matrix or Fibers mixed with local autograft bone as an active comparator. ^{1 2 3 6 7}

Who Is on the Research Team?

Cesar Silva, MD

Principal Investigator

Kuros BioSciences B.V.

Are You a Good Fit for This 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 or medications for at least 3 months without success. It's not suitable for pregnant women, those with previous surgeries at the same spine levels, infections in the area, bone diseases affecting healing, or anyone involved in litigation related to their spinal condition.

Inclusion Criteria

I've tried various non-surgical treatments for my condition for at least 3 months without success.

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

I need a specific spine surgery due to severe back and/or leg pain and spine issues.

Exclusion Criteria

I have had a previous spinal fusion surgery.

Is involved in active litigation relating to his/her spinal condition.

You have a history of drug or alcohol abuse, mental health disorder, or any condition that may affect your ability to follow the study instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Radiographs obtained

Treatment

Participants undergo up to two-level instrumented posterolateral fusion (PLF) procedure with MagnetOs Easypack Putty or Demineralized Bone Matrix

Surgery and immediate recovery

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits at discharge, Week 2, Month 3, Month 6, and Month 12

12 months

Multiple visits including radiographs and CT scans

Interim Analysis

Interim analysis performed once 30 patients have completed their Month 6 visit

What Are the Treatments Tested in This Trial?

Interventions

• Autograft Bone
• MagnetOs Putty

Trial Overview The study compares MagnetOs Putty—a synthetic bone graft extender—with Demineralized Bone Matrix mixed with autograft bone. Patients undergoing lumbar fusion surgery will receive these materials to see how well they help the spine heal and fuse compared to each other.

How Is the Trial Designed?

Group I: MagnetOs Easypack Putty Experimental Treatment 1 Intervention

Interventions * Procedure: Instrumented posterolateral spine fusion * Device; MagnetOs Easypack Putty

Group II: Demineralized Bone Matrix or Fibers (DBX or Grafton) mixed with local autograft bone Active Control 1 Intervention

Interventions * Procedure: Instrumented posterolateral spine fusion * Device: Demineralized Bone Matrix or Fibers mixed with local autograft bone

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+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

Published Research Related to This Trial

In a study of 36 patients undergoing spinal fusion for degenerative spondylolisthesis, OP-1 Putty demonstrated a higher overall success rate (62.5%) compared to autogenous iliac crest bone graft (33.3%) at the 4-year follow-up, indicating its efficacy as a bone graft substitute.

The use of OP-1 Putty was associated with no adverse events related to toxicity or complications, suggesting it is a safe alternative to traditional autograft in promoting spinal fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of OP-1 (rhBMP-7) as a replacement for iliac crest autograft for posterolateral lumbar arthrodesis: minimum 4-year follow-up of a pilot study. Vaccaro, AR., Whang, PG., Patel, T., et al.[2022]

In a study comparing two bone graft expanders, Vitoss and NanOss, used in multilevel lumbar laminectomies, both showed similar times to fusion (5.3 months for Vitoss vs. 4.8 months for NanOss) and high fusion rates (98.6% for Vitoss vs. 100% for NanOss) among patients.

The study also found that the use of NanOss resulted in no reported complications such as pseudarthroses or deep wound infections, suggesting it may be a safe alternative to Vitoss in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary study showing safety/efficacy of nanoss bioactive versus vitoss as bone graft expanders for lumbar noninstrumented fusions. Epstein, NE.[2020]

Limited animal studies suggest that allograft cellular bone matrices (ACBMs) may be as effective or even more effective than traditional autograft techniques for spinal fusion, but human clinical studies have not provided strong evidence to support this.

While ACBMs appear to be safe for use in spinal fusion, the current human studies are limited by small sample sizes and lack of rigorous design, highlighting the need for more robust, unbiased research to determine their true efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating the efficacy of allograft cellular bone matrix for spinal fusion: a systematic review of the literature. Diaz, RR., Savardekar, AR., Brougham, JR., et al.[2021]

In a study of 27 patients undergoing lumbar spinal fusion, the radiographic fusion rate for the Healos collagen-hydroxyapatite sponge combined with bone marrow aspiration was significantly lower (29.63% at two years) compared to the local bone graft group (62.96% at two years).

Although the fusion rate for the Healos/BMA group improved over time, reaching 36.84% at three years, it still remained lower than the local bone graft group, which achieved 78.93% at the same follow-up, indicating that while Healos shows potential, it may not be as effective as traditional grafting methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of radiographic results using HEALOS collagen-hydroxyapatite sponge with bone marrow aspiration versus local bone graft in the same patients undergoing posterolateral lumbar fusion. Kunakornsawat, S., Kirinpanu, A., Piyaskulkaew, C., et al.[2013]

In a study of 73 patients undergoing spinal fusion for degenerative disk disease or spondylolisthesis, the fusion rates at 24 months were similar across three treatment groups: demineralized bone matrix (DBM) with bone marrow, DBM with autograft, and autograft alone, with fusion rates of 63%, 70%, and 67% respectively.

The results indicate that DBM composites can perform comparably to traditional autograft methods in achieving successful spinal fusion, suggesting they are a viable alternative for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demineralized bone matrix composite grafting for posterolateral spinal fusion. Vaccaro, AR., Stubbs, HA., Block, JE.[2022]

Autologous cancellous bone graft is the preferred biological substance for spinal posterior arthrodesis due to its superior cellular activity, while tricortical iliac crest autograft is recommended for anterior interbody fusion, highlighting the importance of graft type in surgical outcomes.

Allografts, while avoiding complications associated with harvesting autografts, do not promote bone fusion as effectively because they lack osteoprogenitor cells, making autograft the gold standard for spinal fusion procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What bone graft substitutes should we use in post-traumatic spinal fusion? Guerado, E., Fuerstenberg, CH.[2013]

In a study involving 32 rabbits, the combination of combined magnetic fields (CMF) treatment and nano-hydroxyapatite (HA) coating significantly improved the fusion rate and new bone formation in posterolateral lumbar fusion, indicating enhanced spinal fusion outcomes.

CMF treatment increased the expression of important bone growth factors BMP-2 and TGF-β1, while nano-HA coating reduced the residual artificial bone, suggesting that both methods effectively enhance the bioactivity and integration of bone grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Combined Magnetic Fields Treatment and Nano-Hydroxyapatite Coating on Porous Biphasic Calcium Phosphate Bone Graft in Rabbit Spinal Fusion Model. Zhuo, X., Li, C., Li, B., et al.[2021]

Citations

1. 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.

2. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/133986-a-retrospective-review-of-magnetos-easypack-putty-tm-bone-graft-used-standalone-in-transforaminal-lumbar-interbody-fusion

A retrospective review of MagnetOs Easypack Putty^TM ... These data support the performance of MagnetOs Easypack Putty used standalone in the intervertebral space to promote spinal fusion. ^Results ...

3. 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.

4. kurosbio.com kurosbio.com/spine/

Spine Growing bone with MagnetOs gives surgeons confidence where it matters most – delivering predictable fusion outcomes.1. In a Level I human clinical study ...

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

MagnetOs™ Global Research Summary - NeuroSpine The study revealed clear differences in efficacy between commercially available bone grafts and demonstrated the efficacy of MagnetOs Putty, as this was the ...

6. kurosbio.com kurosbio.com/spine/putty/

MagnetOs Putty: Advanced bone graft for spinal fusion Speed and efficiency are essential in the operating room, which is why we designed MagnetOs Putty bone graft to be easy to store, handle, and apply.

7. firstwordpharma.com firstwordpharma.com/story/6228345

Kuros Biosciences debuts commercial launch of MagnetOs ... In a retrospective study, MagnetOs achieved a 94.4% fusion rate across 36 levels treated in patients undergoing MIS and open transforaminal ...