Back to resultsPost Marketing Study of MagnetOs Putty Compared to Autograft in Patients Undergoing Posterolateral Lumbar Fusion (PROOF)
Primary Purpose
Degenerative Disc Disease, Spine Fusion
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MagnetOs Putty
Autograft Bone
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative Disc Disease, Spine Fusion
Eligibility 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:
- instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
- osteophyte formation of facet joints or vertebral endplates,
- decreased disc height by > 2 mm, but dependent upon the spinal level,
- scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
- disc degeneration and/or herniation,
- facet degeneration,
- 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.
Sites / Locations
- Henry Ford Hospital SystemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MagnetOs Putty
Autograft Bone
Arm Description
Interventions Procedure: Instrumented posterolateral spine fusion Device; MagnetOs Putty
Interventions Procedure: Instrumented posterolateral spine fusion Device: Autologous bone graft
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/thoracolumbar fusion assessed by plain radiographs.
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.
Functional Outcome by Oswestry Disability Index Questionnaire
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.
Back and Leg Pain by Visual Analog Pain Scale Questionnaire
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.
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.
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
NCT ID
NCT04679844
First Posted
December 18, 2020
Last Updated
July 8, 2021
Sponsor
Kuros Biosurgery AG
Collaborators
Kuros BioSciences B.V., Simplified Clinical Data Systems, LLC, Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT04679844
Brief Title
Post Marketing Study of MagnetOs Putty Compared to Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Acronym
PROOF
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
February 2022 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuros Biosurgery AG
Collaborators
Kuros BioSciences B.V., Simplified Clinical Data Systems, LLC, Henry Ford Health System
4. Oversight
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
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 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.
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.
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
Intra-patient control. Each patient serves as their own control.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MagnetOs Putty
Arm Type
Experimental
Arm Description
Interventions
Procedure: Instrumented posterolateral spine fusion
Device; MagnetOs Putty
Arm Title
Autograft Bone
Arm Type
Active Comparator
Arm Description
Interventions
Procedure: Instrumented posterolateral spine fusion
Device: Autologous bone graft
Intervention Type
Device
Intervention Name(s)
MagnetOs Putty
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Autograft Bone
Intervention Description
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.
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/thoracolumbar fusion assessed by plain radiographs.
Time Frame
Week 6, Month 3, Month 9
Title
Radiographic Fusion by CT Scan
Description
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.
Time Frame
Month 6
Title
Functional Outcome by Oswestry Disability Index Questionnaire
Description
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.
Time Frame
Week 2, Week 6, Month 3, 6, 9, and 12
Title
Back and Leg Pain by Visual Analog Pain Scale Questionnaire
Description
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.
Time Frame
Week 2, Week 6, Month 3, 6, 9, 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 lower extremities, specifically reflexes, muscle strength, sensory, and straight leg raise.
Time Frame
Week 2, Week 6, Month 3, 6, 9, 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, 9, 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
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 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:
instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
osteophyte formation of facet joints or vertebral endplates,
decreased disc height by > 2 mm, but dependent upon the spinal level,
scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
disc degeneration and/or herniation,
facet degeneration,
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal Longlade
Phone
+31 (0)6 2221 00 98
Email
pascal.longlade@kurosbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Trai curtis
Email
trai.curtis@kurosbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Longlade
Organizational Affiliation
Kuros BioSciences B.V.
Official's Role
Study Director
Facility Information:
Facility Name
Henry Ford Hospital System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Tundo, RN, BSN
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post Marketing Study of MagnetOs Putty Compared to Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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