Post Marketing Study of MagnetOs Putty Compared to Autograft in Patients Undergoing Posterolateral Lumbar Fusion (PROOF)

• ClinicalTrials.gov Identifier: NCT04679844
• Recruitment Status: Recruiting
• First Posted: December 22, 2020
• Last Update Posted: July 9, 2021
• Sponsor: Kuros Biosurgery AG
• Collaborators: Kuros BioSciences B.V.; Simplified Clinical Data Systems, LLC; Henry Ford Health System
• Information provided by (Responsible Party): Kuros Biosurgery AG

Study Description

Brief Summary:

This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty 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 Putty 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.

Condition or disease	Intervention/treatment	Phase
Degenerative Disc Disease; Spine Fusion	Device: MagnetOs Putty; Device: Autograft Bone	Not Applicable

Detailed Description:

In this study, following a screening period of a maximum of 30 days, 30 patients will undergo a two-level instrumented posterolateral fusion (PLF) procedure. Prior to surgery, each patient will be randomized to receive MagnetOs Putty on the assigned side of the spine and autograft bone on the other at the diseased levels. They will be followed up at discharge, Week 2, Week 6, Month 3, Month 6, Month 9, 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 Putty will be applied according to the latest Instructions for Use approved in the United States. Specifically, MagnetOs Putty will be used as a bone graft extender mixed with autograft in a 1:1 vol.% in patients with two-level degenerative disc disease with up to grade 1 spondylolisthesis requiring treatment with an instrumented posterolateral spine fusion procedure. The fusion procedure (PLF) will be left to the surgeon's discretion.

Radiographs will be obtained at Screening, Day 0, Week 6, Month 3, and Month 9. CT scans will only be obtained at Month 6 and Month 12.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Intra-patient control. Each patient serves as their own control.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Single-Center Study to Assess the Safety and Performance of MagnetOs Putty Compared to Autograft in Patients Undergoing Two-Level Instrumented Posterolateral Lumbar/Thoracolumbar Fusion (PLF)
• Actual Study Start Date: February 4, 2021
• Estimated Primary Completion Date: February 2022
• Estimated Study Completion Date: August 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: MagnetOs Putty; Interventions; Procedure: Instrumented posterolateral spine fusion; Device; MagnetOs Putty	Device: MagnetOs Putty; MagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side.
Active Comparator: Autograft Bone; Interventions; Procedure: Instrumented posterolateral spine fusion; Device: Autologous bone graft	Device: Autograft Bone; Autologous bone graft used in instrumented posterolateral fusion, 7cc-10cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.

Outcome Measures

Primary Outcome Measures :

1. Radiographic Fusion by CT Scan [ Time Frame: Month 12 ]
   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.

Secondary Outcome Measures :

1. Radiographic Fusion by Plain Radiographs [ Time Frame: Week 6, Month 3, Month 9 ]
   The rate of posterolateral lumbar/thoracolumbar fusion assessed by plain radiographs.
2. Radiographic Fusion by CT Scan [ Time Frame: Month 6 ]
   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.
3. Functional Outcome by Oswestry Disability Index Questionnaire [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
   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 in those rehabilitating from low back pain. The lower the percentage the higher the patient's functionality. 0-20% minimal disability, 80-100% significant disability or bedridden.
4. Back and Leg Pain by Visual Analog Pain Scale Questionnaire [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
   Change in back and leg pain using Visual Analog Pain Scale (0-100). Patient-completed questionnaire scoring pain by using 100 mm line. Zero being no pain, 100 is worst pain imaginable.
5. Neurologic Status by Physical Exam [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
   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.
6. Success Rate [ Time Frame: Week 2, Week 6, Month 3, 6, 9, and 12 ]
   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.

Other Outcome Measures:

1. Safety Endpoint - number of patients with Adverse Events [ Time Frame: 12 Months ]
   The number of patients with Adverse Events from Screening up to Month 12 after surgery.
2. Safety Endpoint - number of patients with Serious Adverse Events [ Time Frame: 12 Months ]
   The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
3. Safety Endpoint - number of patients with Adverse Device Effects [ Time Frame: 12 Months ]
   The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery.
4. Safety Endpoint - number of patients with Device Related Complications [ Time Frame: 12 Months ]
   The number of patients with any complications considered to device related with 12 months after surgery.
5. Health Economic - Duration of Surgery [ Time Frame: 12 Months ]
   Duration of surgery in minutes.
6. Health Economic - Duration of Hospitalization [ Time Frame: 12 Months ]
   Duration of hospital stay in days.
7. Health Economic - Return to Work [ Time Frame: 12 Months ]
   Time to return to work in days.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Patient is able to read/be read, understand, and provide written informed consent and has signed the Institutional Review Board (IRB) approved informed consent.
• Male or female patient ≥ 18 years old.

• Patients with degenerative disc disease with spondylolisthesis or spinal stenosis, leg pain, and/or back pain and requiring two-level instrumented posterolateral lumbar/thoracolumbar fusion (T11 - S1). Degenerative disc disease is defined by the presence of one or more of the following:

  1. instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
  2. osteophyte formation of facet joints or vertebral endplates,
  3. decreased disc height by > 2 mm, but dependent upon the spinal level,
  4. scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
  5. disc degeneration and/or herniation,
  6. facet degeneration,
  7. vacuum phenomenon.
• 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 < two-level fusion or expected to need secondary intervention within one year following surgery.
• Had prior PLF fusion or attempted PLF fusion at the involved levels.
• Had previous decompression at the involved levels.
• Women who are or intend to become pregnant within the next 12 months.
• 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.
• Has degenerative disc disease (DDD) related to a benign or malignant tumor.
• Has history or presence of active malignancy.
• Has known substance abuse, psychiatric disorder, or a condition which, in the opinion of the investigator, may influence the healing or ability to comply with protocol requirements.
• Is involved in active litigation relating to his/her spinal condition.
• Has participated in an investigational study within 30 days prior to surgery for study devices.

Contacts and Locations

Contacts

Contact: Pascal Longlade; +31 (0)6 2221 00 98; pascal.longlade@kurosbio.com

Contact: Trai curtis; trai.curtis@kurosbio.com

Locations

United States, Michigan

Henry Ford Hospital System; Recruiting

Detroit, Michigan, United States, 48322

Contact: Kelly Tundo, RN, BSN

Sponsors and Collaborators

Kuros Biosurgery AG

Kuros BioSciences B.V.

Simplified Clinical Data Systems, LLC

Henry Ford Health System

Investigators

• Study Director: Pascal Longlade; Kuros BioSciences B.V.

More Information

• Responsible Party: Kuros Biosurgery AG
• ClinicalTrials.gov Identifier: NCT04679844
• Other Study ID Numbers: MAG-920-023
• First Posted: December 22, 2020
• Last Update Posted: July 9, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Kuros Biosurgery AG:

Degenerative Disc Disease; Spine Fusion

Additional relevant MeSH terms:

Intervertebral Disc Degeneration; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases