MagnetOs Flex Matrix Compared to Cell Based Allografts in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion (PRECISE)

A Prospective, Randomized, Multi-center Study to Assess the Performance of MagnEtOsTM Flex Matrix Compared to Cell Based Allograft 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.

A cellular based allograft will also be used according to its latest IFU approved in the US. Specifically, the cellular based allograft is an allograft intended for the treatment of musculoskeletal defects.

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Disc Disease; Spine Fusion; Leg Pain and/or Back Pain
• Intervention / Treatment: Device: MagnetOs Flex Matrix

Detailed Description

In this study, following a screening period of a maximum of 30 days, 30 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 a Cell Based Allograft 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. An interim analysis will be performed once 15 patients have completed their Month 6 visit and have measurements for the endpoints available to measure effectiveness. 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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cesar Silva, MD; Email: cesar.silva@kurosbio.com
• Study Contact Backup: Name: Katherine Sage, DO; Phone Number: 617 285 2489; Email: Katherine.Sage@kurosbio.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Requires > four-level fusion or expected to need secondary intervention within one year following surgery.
• 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).
• 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.
• Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
• Receiving treatment with medication interfering with calcium metabolism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cell Based Allograft; Cellular Allografts are a cryopreserved, viable cellular allograft containing cancellous bone and demineralized cortical bone designed for surgical use, applied per spine level at the contralateral side.	Device: MagnetOs Flex Matrix; Procedure: Instrumented Posterolateral Lumbar Fusion
Experimental: MagnetOs Flex Matrix; MagnetOs Flex Matrix use in instrumented posterolateral fusion, 5cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side	Device: MagnetOs Flex Matrix; Procedure: Instrumented Posterolateral Lumbar Fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Month 6
Radiographic Fusion by Plain Radiographs	The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.	Week 2, Week 6, Month 3
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.	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.	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.	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.	Week 2, Week 6, Month 3, Month 6, and Month12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint - number of patients with Serious Adverse Events	The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery	12 Months
Safety Endpoint - number of patients with Adverse Events	The number of patients with Adverse Events from Screening up to Month 12 after surgery.	12 Months
Safety Endpoint - number of patients with Adverse Device Effects	The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery.	12 Months
Safety Endpoint - number of patients with Device Related Complications	The number of patients with any complications considered to device related with 12 months after surgery.	12 Months
Health Economic - Duration of Surgery	Duration of surgery in minutes.	12 Months
Health Economic - Duration of Hospitalization	Duration of hospital stay in days.	12 Months
Health Economic - Return to Work	Time to return to work in days.	12 Months
Health Economic - Quality of Life	Change in Quality of Life measurement using EuroQol-5D/5L scoring	12 Months

Collaborators and Investigators

• Sponsor: Kuros Biosurgery AG
• Collaborators: Simplified Clinical Data Systems, LLC

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 31, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Degenerative Disc Disease; Spine Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: CT-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No