MagnetOs Putty for Spinal Fusion

(PROOF Trial)

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Kuros Biosurgery AG

Must not be taking: Calcium metabolism drugs

Disqualifiers: Pregnancy, Bone disorders, Infections, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment MagnetOs Putty for Spinal Fusion?

Research shows that bone morphogenetic proteins (BMPs), which are similar to components in MagnetOs Putty, have been effective in promoting bone growth and fusion in spinal surgeries, comparable to traditional bone grafts. Additionally, calcium phosphate compounds, which are part of MagnetOs, have been useful in spinal fusion when combined with other materials. ^{1 2 3 4 5}

How is MagnetOs Putty treatment different from other spinal fusion treatments?

MagnetOs Putty is unique because it is a synthetic bone graft substitute designed to promote bone growth and fusion without the need for harvesting the patient's own bone, which can cause pain and complications. Unlike traditional autografts, it avoids the need for a second surgical site and is designed to enhance bone healing and fusion rates. ^{2 4 5 6 7}

Research Team

Katherine Sage, DO

Principal Investigator

Kuros BioSciences B.V.

Eligibility Criteria

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 am 18 years old or older.

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.

Trial Timeline

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

Treatment Details

Interventions

• Autograft Bone (Bone Graft)
• MagnetOs Putty (Bone Graft Extender)

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

What bone graft substitutes should we use in post-traumatic spinal fusion? [2013]

2. Thailand 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. [2013]

3. United States 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. [2021]

4. United States 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Investigating the efficacy of allograft cellular bone matrix for spinal fusion: a systematic review of the literature. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

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

7. United States pubmed.ncbi.nlm.nih.gov

Demineralized bone matrix composite grafting for posterolateral spinal fusion. [2022]