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Bone Graft

MagnetOs Putty for Spinal Fusion (PROOF Trial)

N/A

Waitlist Available

Research Sponsored by Kuros Biosurgery AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 2, month 3, 6, and 12

Awards & highlights

PROOF Trial Summary

This trial is designed to assess the safety and effectiveness of MagnetOs Putty as a bone graft extender mixed with autograft in patients undergoing posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), or lumbar interbody fusion (LIF).

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks of using bone graft extenders include infection risk at the surgical site, inflammation around the area where it's applied, potential allergic reactions to materials used and complications related to improper spine fusion.

PROOF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 2, month 3, 6, and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 2, month 3, 6, and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, month 3, 6, and 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Back and Leg Pain by Visual Analog Pain Scale Questionnaire

Functional Outcome by Oswestry Disability Index Questionnaire

Neurologic Status by Physical Exam

+3 more

Other outcome measures

Health Economic - Duration of Hospitalization

Health Economic - Duration of Surgery

Health Economic - Return to Work

+4 more

PROOF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MagnetOs PuttyExperimental Treatment1 Intervention

Interventions Procedure: Instrumented posterolateral spine fusion Device; MagnetOs Putty

Group II: Demineralized Bone Matrix mixed with Autograft BoneActive Control1 Intervention

Interventions Procedure: Instrumented posterolateral spine fusion Device: Demineralized Bone Matrix mixed with Autograft Bone

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

MagnetOs Putty

2021

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kuros BioSciences B.V.Industry Sponsor

3 Previous Clinical Trials

150 Total Patients Enrolled

Simplified Clinical Data Systems, LLCIndustry Sponsor

6 Previous Clinical Trials

154 Total Patients Enrolled

Kuros Biosurgery AGLead Sponsor

10 Previous Clinical Trials

781 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical study actively seeking participants?

"Affirmative. Data retrieved from clinicaltrials.gov attests to the fact that this scientific inquiry, which was first published on February 4th 2021, is currently recruiting test subjects. 30 individuals need to be enrolled in one medical centre for successful completion of the trial."

Answered by AI

What is the current scope of participation in this experiment?

"Yes, the information on clinicialtrials.gov confirms that this trial is in the process of recruiting patients. This medical study was first reported on February 4th 2021 and has since been updated as recently as July 8th 2021. The research team seeks to recruit 30 persons from one site."

Answered by AI