Post Marketing Clinical Follow up Study for MagnetOs Putty in Patients With Degenerative Disc Disease
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Degenerative Disc Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Single arm, single-center, post market surveillance study.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 25 years and 75 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT04128852
- Collaborators
- Factory CRO
- The London Clinic
- Kuros BioSciences B.V.
- Investigators
- Principal Investigator: Panagiotis Liantis London Spine Clinic