Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease (PROGRESS)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: MagnetOs Putty

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marion Bertrand; Phone Number: +31 (0)30 740 04 55; Email: marion.bertrand@kurosbio.com
• Study Contact Backup: Name: Pascal Longlade; Phone Number: +31 (0)6 2221 00 98; Email: pascal.longlade@kurosbio.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • London Spine Clinic
    • Contact: Panagiotis Liantis; Email: liantisp@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent by the patient.
2. Male or female patient ≥ 25 up to and including 75 years old.

3. 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:

   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.
4. Patients with an Oswestry Disability Index (ODI) score ≥ 30.
5. Patients with a Visual Analogue Scale (VAS) leg score ≥ 40.
6. 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:

1. To treat conditions in which general bone grafting is not advisable.
2. 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).
3. In case of significant vascular impairment proximal to the graft site.
4. In case of severe metabolic or systemic bone disorders that affect bone or wound healing.
5. In case of acute and chronic infections in the operated area (soft tissue infections; inflammation, bacterial bone diseases; osteomyelitis).
6. When intraoperative soft tissue coverage is not planned or possible.
7. In direct contact with the articular space.
8. In case of treatment with medication interfering with the calcium metabolism.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic interbody fusion by CT scan	Interbody fusion at Month 6 post-surgery assessed by CT-scans as defined by an independent radiology expert.	6 months
Functional outcome by the Oswestry Disability Index (ODI)	Functional outcome by the Oswestry Disability Index (ODI) questionnaire	Week 6, months 3, 6 and 12.
Back pain and leg pain by Visual Analogue Scale (VAS)	Change in back pain and leg pain using VAS scoring .	Week 6, months 3, 6 and 12.
Neurological status by interviewing patient	Change in neurological status obtained during interviewing the patient, to gain information on deficits.	Week 6, months 3, 6 and 12.
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.	Month 3 and between Month 3 and Month 12 post-surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety endpoint - number of patients with Adverse Events	Number of patients with Adverse Events, local and systemic from Screening up to Month 12 after surgery.	12 months
Safety endpoints - number of patients with Serious Adverse Events	Number of patients with Serious Adverse Events, local and systemic from Screening up to Month 12 after surgery.	12 months
Safety endpoints - number of Adverse Device Effects	Number of Adverse Device Effects.	12 months
Safety endpoints - changes in vital signs (Heart Rate - HR).	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.	12 months
Safety endpoints - changes in vital signs (Blood Pressure).	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.	12 months
Safety endpoints - changes in vital signs (Respiratory Rate - RR).	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.	12 months
Safety endpoints - changes in vital signs (body temperature).	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.	12 months
Pharmacoeconomic - duration of surgery in hours.	Duration of surgery in hours.	12 months
Pharmacoeconomic - duration of hospitalization in days.	Duration of hospitalization in days.	12 months
Pharmacoeconomic - time to return to work in days.	Time to return to work in days.	12 months
Pharmacoeconomic - number of patients with any unscheduled visit due to complications considered to be related to the investigational device.	Number of patients with any unscheduled visit due to complications considered to be related to the investigational device within 12 months post-surgery.	12 months
Pharmacoeconomic - patient satisfaction by using EQ-5DL questionnaire.	Patient satisfaction (EQ-5D-5L).	12 months

Collaborators and Investigators

• Sponsor: Kuros Biosurgery AG
• Collaborators: Factory CRO; Kuros BioSciences B.V.; The London Clinic
• Investigators: Principal Investigator: Panagiotis Liantis, London Spine Clinic

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Estimated): December 1, 2022
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: October 4, 2019
• First Submitted That Met QC Criteria: October 15, 2019
• First Posted (Actual): October 16, 2019

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Spinal Fusion
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: MAG-919-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No