Spinal Deformity, Spinal Fracture, Spinal Tumor, Spine Degeneration, Spine Spondylosis Thoracic
Conditions
Brief summary
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.
Interventions
PROCEDURESpine surgery
Implantation of spine Interbody Fusion Devices and/or Posterior fixation System.
Sponsors
Clariance
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Considered as adult in the respective geography (18 years old or older for France and 21 years old or older for United-States). * Indicated for treatment with one or more commercially available sponsor spine device included into the study. * For France only, affiliated with or beneficiary of a social security scheme.
Exclusion criteria
* Subjects who are not able to comply with the study procedures based on the judgment of the investigator (e.g., inability to comprehend study related questions, inability to keep scheduled assessment times). * Subjects who are considered as vulnerable: minor, pregnant woman or people under legal protection (guardianship or curatorship). * Contraindicated for spine surgery utilizing a commercially available sponsor spine device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revision rate | Year 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Back & Leg Pain Visual Analog Score (VAS) | Pre-op; Week 9; Month 6; Year 1; Year 2 | 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). |
| Oswestry Disability Index (ODI) | Pre-op; Week 9; Month 6; Year 1; Year 2 | 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). |
| Self-report multipurpose short-form (SF-12v2®) | Pre-op; Week 9; Month 6; Year 1; Year 2 | 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). |
| Subject's Satisfaction | Week 9; Month 6; Year 1; Year 2 | 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. |
| Radiological parameter: bony fusion | Week 9; Month 6; Year 1; Year 2 | Evaluation of the interbody fusion from either X-rays or CT-scan images. |
| Adverse Events | Through study completion, an average of 2 years | 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. |
| Device Deficiencies | Through study completion, an average of 2 years | Number of inadequacies of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance. |
Countries
France
Contacts
CONTACTFlorian Laboulfie
Outcome results
None listed