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International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF).
The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting.
The primary objective is to demonstrate that the use of the study devices is safe.
The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ERISMA® LP/LP EVO | 120 subjects with ERISMA® LP/LP EVO implant |
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| ERISMA® Deformity | 120 subjects with ERISMA® Deformity implant |
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| ERISMA® MIS | 120 subjects with ERISMA® MIS implant |
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| Idys® TLIF PEEK | 50 subjects with Idys® TLIF PEEK implant |
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| Idys® TLIF TiVAC | 50 subjects with Idys® TLIF TiVAC implant |
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| Idys® TLIF 3DTi | 50 subjects with Idys® TLIF 3DTi implant |
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| Idys® ALIF PEEK |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spine surgery | Procedure | Implantation of spine Interbody Fusion Devices and/or Posterior fixation System. |
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| Measure | Description | Time Frame |
|---|---|---|
| Revision rate | Revision (each time a primary study implant is removed during an additional necessary surgery) rates, as a percentage of the total of cases per primary study device. | Year 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Back & Leg Pain Visual Analog Score (VAS) | Self-report scale consisting in a 10-centimeter horizontal line with each end being an extreme label of the pain or discomfort experienced by the subject. The extreme labels are "no pain" (corresponding to the scale of 0) and "the worst pain imaginable" (corresponding to the scale of 100). | Pre-op; Week 9; Month 6; Year 1; Year 2 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with thoracolumbar disease, and who require spine surgery with Interbody Fusion Device and/or Posterior fixation System
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Florian Laboulfie | Contact | +33 7 81 20 03 13 | f.laboulfie@clariance-spine.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santy Orthopedic Center | Recruiting | Lyon | France |
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| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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50 subjects with Idys® ALIF PEEK implant |
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| Idys® ALIF TiVAC | 50 subjects with Idys® ALIF TiVAC implant |
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| Idys® ALIF 3DTi | 50 subjects with Idys® ALIF 3DTi implant |
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| Idys® ALIF ZP 3DTi | 50 subjects with Idys® ALIF ZP 3DTi implant |
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| Idys® LLIF 3DTi | 50 subjects with Idys® LLIF 3DTi implant |
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| Oswestry Disability Index (ODI) | Self-report scale with 10 items each which 6 statements referring to the subject's life in different scenarios. The answers are scored on a 0 - 5 points scale that is then transformed to result in a score that ranges from 0% (indicating least disability) to 100% (indicating most disability). | Pre-op; Week 9; Month 6; Year 1; Year 2 |
| Self-report multipurpose short-form (SF-12v2®) | The SF-12v2® measures eight components of general health: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality (energy/fatigue), social functioning, role limitations due to emotional problems and mental health (psychological distress and psychological wellbeing). | Pre-op; Week 9; Month 6; Year 1; Year 2 |
| Subject's Satisfaction | Five questions regarding the surgery outcomes, if the subject would recommend the surgery to family members and if the subject would still undergo the surgery. Each answer indicates a different level of satisfaction. | Week 9; Month 6; Year 1; Year 2 |
| Radiological parameter: bony fusion | Evaluation of the interbody fusion from either X-rays or CT-scan images. | Week 9; Month 6; Year 1; Year 2 |
| Adverse Events | Number of untoward medical occurrences, unintended diseases or injuries, or untoward clinical signs (including abnormal laboratory findings) in subjects , users or other persons, whether or not related to the investigational medical device and whether anticipated or unanticipated. May be serious or not. | Through study completion, an average of 2 years |
| Device Deficiencies | Number of inadequacies of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance. | Through study completion, an average of 2 years |
| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |