PROGRESS: Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: MagnetOs Putty 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. |
Device: MagnetOs Putty
MagnetOs Putty has a CE-mark (2115660CE01) as well as FDA 510(k) clearance (K171563/K181958).
|
Outcome Measures
Primary Outcome Measures
- Radiographic interbody fusion by CT scan [12 months]
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 [6 months]
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) [Week 6, months 3, 6 and 12.]
Functional outcome by the Oswestry Disability Index (ODI) questionnaire
- Back pain and leg pain by Visual Analogue Scale (VAS) [Week 6, months 3, 6 and 12.]
Change in back pain and leg pain using VAS scoring .
- Neurological status by interviewing patient [Week 6, months 3, 6 and 12.]
Change in neurological status obtained during interviewing the patient, to gain information on deficits.
- Success rate [Month 3 and between Month 3 and Month 12 post-surgery.]
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.
Other Outcome Measures
- Safety endpoint - number of patients with Adverse Events [12 months]
Number of patients with Adverse Events, local and systemic from Screening up to Month 12 after surgery.
- Safety endpoints - number of patients with Serious Adverse Events [12 months]
Number of patients with Serious Adverse Events, local and systemic from Screening up to Month 12 after surgery.
- Safety endpoints - number of Adverse Device Effects [12 months]
Number of Adverse Device Effects.
- Safety endpoints - changes in vital signs (Heart Rate - HR). [12 months]
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.
- Safety endpoints - changes in vital signs (Blood Pressure). [12 months]
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.
- Safety endpoints - changes in vital signs (Respiratory Rate - RR). [12 months]
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.
- Safety endpoints - changes in vital signs (body temperature). [12 months]
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.
- Pharmacoeconomic - duration of surgery in hours. [12 months]
Duration of surgery in hours.
- Pharmacoeconomic - duration of hospitalization in days. [12 months]
Duration of hospitalization in days.
- Pharmacoeconomic - time to return to work in days. [12 months]
Time to return to work in days.
- Pharmacoeconomic - number of patients with any unscheduled visit due to complications considered to be related to the investigational device. [12 months]
Number of patients with any unscheduled visit due to complications considered to be related to the investigational device within 12 months post-surgery.
- Pharmacoeconomic - patient satisfaction by using EQ-5DL questionnaire. [12 months]
Patient satisfaction (EQ-5D-5L).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Written informed consent by the patient.
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Male or female patient ≥ 25 up to and including 75 years old.
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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:
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instability (angulation ≥ 5 degrees or translation ≥ 3 mm on flexion/extension radiographs),
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osteophyte formation of facet joints or vertebral endplates,
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decreased disc height by > 2 mm, but dependent upon the spinal level,
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scarring/thickening of ligamentum flavum, annulus fibrosis or facet joint capsule,
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disc degeneration and/or herniation,
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facet degeneration,
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vacuum phenomenon.
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Patients with an Oswestry Disability Index (ODI) score ≥ 30.
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Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
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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:
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To treat conditions in which general bone grafting is not advisable.
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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).
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In case of significant vascular impairment proximal to the graft site.
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In case of severe metabolic or systemic bone disorders that affect bone or wound healing.
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In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
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When intraoperative soft tissue coverage is not planned or possible.
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In direct contact with the articular space.
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In case of treatment with medication interfering with the calcium metabolism.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | London Spine Clinic | London | United Kingdom |
Sponsors and Collaborators
- Kuros Biosurgery AG
- Factory CRO
- The London Clinic
- Kuros BioSciences B.V.
Investigators
- Principal Investigator: Panagiotis Liantis, London Spine Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MAG-919-013