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

Primary Purpose

Degenerative Disc Disease, Spine Fusion

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MagnetOs Putty
Sponsored by
Kuros Biosurgery AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative Disc Disease, Spine Fusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient is able to read/be read, understand, and provide written informed consent and has signed the Investigational Review Board (IRB) approved informed consent.
  2. Male or female patient ≥ 18 years old.
  3. Patients with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar fusion (L2 - S1).
  4. 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:

  1. Requires > three-level fusion or expected to need secondary intervention within one year following surgery.
  2. To treat conditions in which general bone grafting is not advisable.
  3. 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).
  4. In case of significant vascular impairment proximal to the graft site.
  5. In case of severe metabolic or systemic bone disorders (e.g., osteogenesis imperfecta or Paget's Disease) that affect bone or wound healing.
  6. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
  7. When intraoperative soft tissue coverage is not planned or possible.
  8. Undergoing any procedure that allows MagnetOs to come in direct contact with the articular space.
  9. Receiving treatment with medication interfering with calcium metabolism.
  10. Women who are or intend to become pregnant within the next 12 months.

Sites / Locations

  • Orthopaedic Institute of Western Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

MagnetOs Putty

Local autograft

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Radiographic Fusion by Plain Radiographs
The rate of posterolateral lumbar fusion assessed by plain radiographs
Posterolateral lumbar fusion assessed by CT-scan
The rate of posterolateral lumbar 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
Interbody lumbar fusion assessed by plain radiographs
The rate of interbody lumbar fusion assessed by plain radiographs at Week 2, Week 6, Month 3, Month 6, and Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior vertebral bodies
Functional Outcome by Oswestry Disability Index
Change in functional score using Oswestry Disability Index questionnaire. Patient-completed survey provides subjective percentage score for level of function (disability) in activities of daily living. Score rage 0-100 percent. The lower the percentages indicate higher functionality; 0-20% minimal disability, 80-100% significant disability.
General, back and Leg Pain by Visual Analog Pain Scale
Change in general, 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.
Neurologic Status by Physical Exam
Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for the lower extremities, specifically in reflexes, muscle strength, sensory, and straight leg raise.
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

Full Information

First Posted
December 18, 2020
Last Updated
October 26, 2022
Sponsor
Kuros Biosurgery AG
Collaborators
Orthopaedic Institute of Western Kentucky, Simplified Clinical Data Systems, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04679896
Brief Title
Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Acronym
PARTNER
Official Title
A Prospective, Randomized, Single-center Study to Assess the Performance of MagnetOs Putty Compared to Local Autograft in Patients Undergoing up to Three-level Instrumented Posterolateral Lumbar Fusion (PLF).
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuros Biosurgery AG
Collaborators
Orthopaedic Institute of Western Kentucky, Simplified Clinical Data Systems, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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 leg pain and/or back pain 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.
Detailed Description
In this study, following a screening period of a maximum of 30 days, 30 patients will undergo up to a three-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 local autograft bone 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 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 with leg pain and/or back pain requiring up to three-level instrumented posterolateral lumbar 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. CT scans will only be obtained at Month 6 and Month 12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease, Spine Fusion
Keywords
Degenerative Disc Disease, Spine Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Intra-patient control. Each patient serves as their own control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MagnetOs Putty
Arm Type
Experimental
Arm Description
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.
Arm Title
Local autograft
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
MagnetOs Putty
Intervention Description
Procedure: Instrumented posterolateral spine fusion
Primary Outcome Measure Information:
Title
Radiographic Fusion by CT Scan
Description
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.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Radiographic Fusion by Plain Radiographs
Description
The rate of posterolateral lumbar fusion assessed by plain radiographs
Time Frame
Week 2, Week 6, Month 3
Title
Posterolateral lumbar fusion assessed by CT-scan
Description
The rate of posterolateral lumbar 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
Time Frame
Month 6
Title
Interbody lumbar fusion assessed by plain radiographs
Description
The rate of interbody lumbar fusion assessed by plain radiographs at Week 2, Week 6, Month 3, Month 6, and Month 12. Radiographic as determined by evidence of bridging trabeculae or continuous bony connection between the superior and inferior vertebral bodies
Time Frame
Week 2, Week 6, Month 3, Month 6, Month 12
Title
Functional Outcome by Oswestry Disability Index
Description
Change in functional score using Oswestry Disability Index questionnaire. Patient-completed survey provides subjective percentage score for level of function (disability) in activities of daily living. Score rage 0-100 percent. The lower the percentages indicate higher functionality; 0-20% minimal disability, 80-100% significant disability.
Time Frame
Week 2, Week 6, Month 3, 6, and 12
Title
General, back and Leg Pain by Visual Analog Pain Scale
Description
Change in general, 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.
Time Frame
Week 2, Week 6, Month 3, 6, and 12
Title
Neurologic Status by Physical Exam
Description
Change in neurologic status by examination to document stable, improved, or deficits in condition. Stable or improved findings for the lower extremities, specifically in reflexes, muscle strength, sensory, and straight leg raise.
Time Frame
Week 2, Week 6, Month 3, 6, and 12
Title
Success Rate
Description
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
Time Frame
Week 2, Week 6, Month 3, 6, and 12
Other Pre-specified Outcome Measures:
Title
Safety Endpoint - number of patients with Adverse Events
Description
The number of patients with Adverse Events from Screening up to Month 12 after surgery
Time Frame
12 Months
Title
Safety Endpoint - number of patients with Serious Adverse Events
Description
The number of patients with Serious Adverse Events from Screening up to Month 12 after surgery
Time Frame
12 Months
Title
Safety Endpoint - number of patients with Adverse Device Effects
Description
The number of patients with Adverse Device Effects from Screening up to Month 12 after surgery
Time Frame
12 Months
Title
Safety Endpoint - number of patients with Device Related Complications
Description
The number of patients with any complications considered to device related with 12 months after surgery
Time Frame
12 Months
Title
Health Economic - Duration of Surgery
Description
Duration of surgery in minutes
Time Frame
12 Months
Title
Health Economic - Duration of Hospitalization
Description
Duration of hospital stay in days
Time Frame
12 Months
Title
Health Economic - Return to Work
Description
Time to return to work in days
Time Frame
12 Months
Title
Health Economic - Quality of Life
Description
Change in Quality of Life measurement using EuroQol 5D/5L scoring
Time Frame
Week 6, Month 3, 6, and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 three-level instrumented posterolateral lumbar fusion (L2 - 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 > three-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. Women who are or intend to become pregnant within the next 12 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Longlade, MD
Organizational Affiliation
Kuros BioSciences B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Orthopaedic Institute of Western Kentucky
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42001
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion

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