A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices

Study Overview
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Brief Summary
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This protocol is designed to study Orthofix regulatory approved and commercially available spine devices to generate Real World Evidence (RWE) of device safety and performance in the treatment of patients with spine injuries and/or disorders following the local medical standard of care. The clinical data generated from this study will support compliance to global regulatory requirements including but not limited to the European Medical Device Regulation (EU MDR) for the applicable devices.

Official Title
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A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices

Conditions
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Spinal Disorders/Injuries

Intervention / Treatment
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* Procedure: Spinal Surgery


Participation Criteria
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Eligibility Criteria
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Patient diagnosed with a spine injury/disorder and undergoing or has undergone spine procedure at the participating investigative centers utilizing Orthofix Spine devices. Patient is 18 years or older at the time of surgery. Patient is capable of understanding the content of the patient information / Informed Consent Form (ICF) for the prospective segment of the study. Patient is willing and able to participate in the prospective data collection protocol and comply with the required data collection. For retrospective segment of the study: A waiver of consent for retrospective data collection is in place OR an informed consent is obtained from the participating patient prior to data collection as required by local regulations. Patient may be excluded from study participation if there are other concurrent medical or other conditions (chronic or acute in nature) that in opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implanted with Orthofix Spinal products<br>Study will include 2000+ subjects implanted with Orthofix Spine devices including spine fixation systems and motion preservation systems (i.e. M6-C artificial cervical disc and M6-L artificial lumbar disc) | Procedure: Spinal Surgery<br>* Implanted with Orthofix Spinal products<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety Assessment: Device or procedure related adverse events | Evaluation of device related or procedure related adverse events | Pre-Operative to up to 10-years Post-Operative | 
| Primary Effectiveness Assessments: Fusion status measured radiographs | Fusion status measured utilizing quantitative and qualitative radiographic assessments as applicable | Intra-operative to up to 10-years Post-Operative | 
| Primary Effectiveness Assessment | Improvement in pain measured with Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS): NRS is an 11-point scale for patient self-reporting of pain. Patients rate their current pain intensity at the time of the visit from 0 (no pain) to 10 (worst possible pain) by selecting a number on a horizontal bar. NRS scores for the evaluation of pain have been categorized as mild (1-3), moderate (4-6), or severe (7-10). VAS scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. | Intra-operative to up to 10-years Post-Operative | 
| Primary Effectiveness Assessment | Improvement in function as measured with Neck Disability Index (NDI) or Oswestry Disability Index (ODI). NDI includes 4 items that relate to subjective symptomatology (pain severity, headache, concentration, sleeping) and 6 items that relate to activities of daily living (lifting, work, driving, recreation, personal care, reading). Each item is scored from 0 to 5, with higher scores corresponding to greater disability. A total NDI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the NDI score ranges from 0 to 100. The ODI was developed as a specific outcomes tool for subjects suffering from back pain. The questionnaire scores 10 aspects of the subject's home and work life and analgesic use. The disability index is then calculated as a percentage with a high percentage indicating a high level of disability. | Intra-operative to up to 10-years Post-Operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Safety Assessments: Additional required medical treatments and/or supplemental surgical procedure | Additional required medical treatments and/or supplemental surgical procedure(s) at the index level (including revision, removal, reoperation, or supplemental fixation). Percentage of patients that required additional/supplemental treatments and/or surgical procedures and time to additional surgery. | Pre-Operative to up to 10-years Post-Operative | 
| Secondary Effectiveness Assessments: Quality of Life assessment | Quality of Life score measured utilizing PROMIS-29 PROMIS®-29 Profile v2. PROMIS (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions. This instrument is comprised of 8 constructs: Physical Function; Anxiety; Depression; Fatigue; Sleep Disturbance; Ability to Participate in Social Roles and Activities; Pain Interference; and Pain Intensity that closely evaluate the impact of a patient's health on their quality of life | Pre-Operative to up to 10-years Post-Operative | 
| Secondary Effectiveness Assessments: Changes in neurological function | Maintenance or improvement in neurological function Neurological function will be evaluated, where neurological examination is performed as part of standard of care. The outcome of neurological function assessment (normal versus abnormal) and details related to abnormal sensory function (i.e. absent/impaired/normal/other) will be collected as appropriate. | Pre-Operative to up to 10-years Post-Operative | 
| Secondary Effectiveness Assessments: Work and Activity status | Work/Activity status Return to Work: The ability to and the time it takes for the subjects to return to work from the date of surgery will be documented. Return to Normal/Usual activities: The ability to and the time it takes for the subjects to return to normal daily activities from the date of surgery will be documented. | Pre-Operative to up to 10-years Post-Operative | 
| Secondary Effectiveness Assessments: Patient Satisfaction | Patient satisfaction At ≥ 6-months after the index procedure, subjects will be asked how satisfied they are with the results of their surgery on a 5-point Likert Scale (Very Satisfied; Satisfied; Neutral; Unsatisfied; Very Unsatisfied). | Pre-Operative to up to 10-years Post-Operative | 
| Secondary Effectiveness Assessments: Duration of Surgery | Surgery time | Pre-Operative to up to 10-years Post-Operative | 
| Secondary Effectiveness Assessments: Duration of Hospital stay | Length of hospital stay | Pre-Operative to up to 10-years Post-Operative | 
| Secondary Safety Assessments: Device and/or procedure-related deficiencies | Quantitative and qualitative radiographic assessments for evidence of device and/or procedure-related deficiencies. Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, safety or performance will be documented. Percentage of patients with device deficiency will be reported | Pre-Operative to up to 10-years Post-Operative |