Back to resultsPost Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease (PROGRESS)
Primary Purpose
Degenerative Disc Disease
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
MagnetOs Putty
Sponsored by
About this trial
This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Spinal Fusion
Eligibility Criteria
Inclusion Criteria:
- Written informed consent by the patient.
- Male or female patient ≥ 25 up to and including 75 years old.
Patients with degenerative disc disease with up to grade 1 spondylolisthesis and with leg pain requiring 1 to 3 level laminectomy and a single/two-level fusion (L2 - 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.
- Patients with an Oswestry Disability Index (ODI) score ≥ 30.
- Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
- Failed conservative treatment (physical therapy, bed rest, medications, spinal injections or transcutaneous electrical nerve stimulation) for a period of 6 months prior to study enrollment.
Exclusion Criteria:
Per the current Instruction For Use, MagnetOs Putty must not be used in the following clinical situations:
- 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 stabilisation is not possible).
- In case of significant vascular impairment proximal to the graft site.
- In case of severe metabolic or systemic bone disorders 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.
- In direct contact with the articular space.
- In case of treatment with medication interfering with the calcium metabolism.
Sites / Locations
- London Spine ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MagnetOs Putty
Arm Description
MagnetOs Putty will be applied according to the latest Instructions For Use (IFU) approved in Europe. Specifically, MagnetOs Putty will be used as bone void filler.
Outcomes
Primary Outcome Measures
Radiographic interbody fusion by CT scan
The rate of interbody fusion assessed by CT-scan at Month 12. Radiographic fusion using CT-scan will be defined by an independent radiology expert at Month 12 post-surgery and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body.
Secondary Outcome Measures
Radiographic interbody fusion by CT scan
Interbody fusion at Month 6 post-surgery assessed by CT-scans as defined by an independent radiology expert.
Functional outcome by the Oswestry Disability Index (ODI)
Functional outcome by the Oswestry Disability Index (ODI) questionnaire
Back pain and leg pain by Visual Analogue Scale (VAS)
Change in back pain and leg pain using VAS scoring .
Neurological status by interviewing patient
Change in neurological status obtained during interviewing the patient, to gain information on deficits.
Success rate
Number of patients with Secondary Surgical Interventions (SSI's) such as revisions, re-operations, removals, supplemental fixations, and any other procedure that adjust or in any way remove part of the original implant configuration with or without replacement of the components.
Full Information
NCT ID
NCT04128852
First Posted
October 4, 2019
Last Updated
July 6, 2021
Sponsor
Kuros Biosurgery AG
Collaborators
Factory CRO, The London Clinic, Kuros BioSciences B.V.
1. Study Identification
Unique Protocol Identification Number
NCT04128852
Brief Title
Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
Acronym
PROGRESS
Official Title
A Prospective, Single Arm, Single-center Study to Assess the Safety and Performance of MagnetOs Putty in Patients Undergoing Single/Two-level Lateral Lumbar Interbody Fusion
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuros Biosurgery AG
Collaborators
Factory CRO, The London Clinic, Kuros BioSciences B.V.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a post-marketing clinical follow-up study for MagnetOs Putty. MagnetOs Putty is a synthetic bone-like material which is routinely used by surgeons as a treatment for patients with degenerative disc disease who will undergo surgery for spinal fusion (extreme lateral interbody fusion (XLIF)). MagnetOs Putty will be used according to the instructions for use.
Detailed Description
In this study, following a screening period of maximum 30 days, 20 patients will undergo a single/two-level XLIF procedure and will receive MagnetOs Putty at the diseased level(s). They will be followed up at discharge, Week 6, Month 3, Month 6 and Month 12 post-surgery. The primary endpoint will be analyzed at Month 12.
In this study, MagnetOs Putty will be applied according to the latest Instructions For Use (IFU) approved in Europe. Specifically, MagnetOs Putty will be used as bone void filler in Degenerative Disc Disease patients with up to grade 1 spondylolisthesis requiring treatment with single or two-level lateral lumbar interbody fusion (XLIF). In the context of filling of intervertebral implant (e.g. interbody cage), the choice of implant should be appropriate to enable successful fusion but will be left to the investigator discretion.
The extreme lateral interbody fusion surgical procedure will be left to the investigator discretion.
Radiographs will be taken at Screening, Day 0, Month 3 and 12, while CT-scans will only be taken 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
Keywords
Spinal Fusion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm, single-center, post market surveillance study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MagnetOs Putty
Arm Type
Other
Arm Description
MagnetOs Putty will be applied according to the latest Instructions For Use (IFU) approved in Europe. Specifically, MagnetOs Putty will be used as bone void filler.
Intervention Type
Device
Intervention Name(s)
MagnetOs Putty
Intervention Description
MagnetOs Putty has a CE-mark (2115660CE01) as well as FDA 510(k) clearance (K171563/K181958).
Primary Outcome Measure Information:
Title
Radiographic interbody fusion by CT scan
Description
The rate of interbody fusion assessed by CT-scan at Month 12. Radiographic fusion using CT-scan will be defined by an independent radiology expert at Month 12 post-surgery and determined by evidence of bridging trabeculae or continuous bony connection between superior and inferior vertebral body.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Radiographic interbody fusion by CT scan
Description
Interbody fusion at Month 6 post-surgery assessed by CT-scans as defined by an independent radiology expert.
Time Frame
6 months
Title
Functional outcome by the Oswestry Disability Index (ODI)
Description
Functional outcome by the Oswestry Disability Index (ODI) questionnaire
Time Frame
Week 6, months 3, 6 and 12.
Title
Back pain and leg pain by Visual Analogue Scale (VAS)
Description
Change in back pain and leg pain using VAS scoring .
Time Frame
Week 6, months 3, 6 and 12.
Title
Neurological status by interviewing patient
Description
Change in neurological status obtained during interviewing the patient, to gain information on deficits.
Time Frame
Week 6, months 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, and any other procedure that adjust or in any way remove part of the original implant configuration with or without replacement of the components.
Time Frame
Month 3 and between Month 3 and Month 12 post-surgery.
Other Pre-specified Outcome Measures:
Title
Safety endpoint - number of patients with Adverse Events
Description
Number of patients with Adverse Events, local and systemic from Screening up to Month 12 after surgery.
Time Frame
12 months
Title
Safety endpoints - number of patients with Serious Adverse Events
Description
Number of patients with Serious Adverse Events, local and systemic from Screening up to Month 12 after surgery.
Time Frame
12 months
Title
Safety endpoints - number of Adverse Device Effects
Description
Number of Adverse Device Effects.
Time Frame
12 months
Title
Safety endpoints - changes in vital signs (Heart Rate - HR).
Description
Changes in vital sign - HR (bpm) from screening to Day 0 (pre-surgery) up to discharge, Week 6, Month 3, 6 and 12 post-surgery.
Time Frame
12 months
Title
Safety endpoints - changes in vital signs (Blood Pressure).
Description
Changes in vital signs - BP (mmHg) from screening to Day 0 (pre-surgery) up to discharge, Week 6, Month 3, 6 and 12 post-surgery.
Time Frame
12 months
Title
Safety endpoints - changes in vital signs (Respiratory Rate - RR).
Description
Changes in vital sign - RR (breaths per minute) (from screening to Day 0 (pre-surgery) up to discharge, Week 6, Month 3, 6 and 12 post-surgery.
Time Frame
12 months
Title
Safety endpoints - changes in vital signs (body temperature).
Description
Changes in vital sign - body temperature (degrees Celsius) from screening to Day 0 (pre-surgery) up to discharge, Week 6, Month 3, 6 and 12 post-surgery.
Time Frame
12 months
Title
Pharmacoeconomic - duration of surgery in hours.
Description
Duration of surgery in hours.
Time Frame
12 months
Title
Pharmacoeconomic - duration of hospitalization in days.
Description
Duration of hospitalization in days.
Time Frame
12 months
Title
Pharmacoeconomic - time to return to work in days.
Description
Time to return to work in days.
Time Frame
12 months
Title
Pharmacoeconomic - number of patients with any unscheduled visit due to complications considered to be related to the investigational device.
Description
Number of patients with any unscheduled visit due to complications considered to be related to the investigational device within 12 months post-surgery.
Time Frame
12 months
Title
Pharmacoeconomic - patient satisfaction by using EQ-5DL questionnaire.
Description
Patient satisfaction (EQ-5D-5L).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Written informed consent by the patient.
Male or female patient ≥ 25 up to and including 75 years old.
Patients with degenerative disc disease with up to grade 1 spondylolisthesis and with leg pain requiring 1 to 3 level laminectomy and a single/two-level fusion (L2 - 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.
Patients with an Oswestry Disability Index (ODI) score ≥ 30.
Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
Failed conservative treatment (physical therapy, bed rest, medications, spinal injections or transcutaneous electrical nerve stimulation) for a period of 6 months prior to study enrollment.
Exclusion Criteria:
Per the current Instruction For Use, MagnetOs Putty must not be used in the following clinical situations:
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 stabilisation is not possible).
In case of significant vascular impairment proximal to the graft site.
In case of severe metabolic or systemic bone disorders 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.
In direct contact with the articular space.
In case of treatment with medication interfering with the calcium metabolism.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion Bertrand
Phone
+31 (0)30 740 04 55
Email
marion.bertrand@kurosbio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal Longlade
Phone
+31 (0)6 2221 00 98
Email
pascal.longlade@kurosbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panagiotis Liantis
Organizational Affiliation
London Spine Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Spine Clinic
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panagiotis Liantis
Email
liantisp@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
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