Spinal Disorders/Injuries
Conditions
Brief summary
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.
Interventions
PROCEDURESpinal Surgery
Implanted with Orthofix Spinal products
Sponsors
Orthofix Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient diagnosed with a spine injury/disorder and undergoing or has undergone spine procedure at the participating investigative centers utilizing Orthofix Spine devices. 2. Patient is 18 years or older at the time of surgery. 3. Patient is capable of understanding the content of the patient information / Informed Consent Form (ICF) for the prospective segment of the study. 4. Patient is willing and able to participate in the prospective data collection protocol and comply with the required data collection. Note: 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.
Exclusion criteria
1\. Patient may be excluded from study participation if there are other concurrent medical or other conditions (chronic or acute in nature) that in the opinion of the participating investigator may prevent participation or otherwise render patient ineligible for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Safety Assessment: Device or procedure related adverse events | Pre-Operative to up to 10-years Post-Operative | Evaluation of device related or procedure related adverse events |
| Primary Effectiveness Assessments: Fusion status measured radiographs | Intra-operative to up to 10-years Post-Operative | Fusion status measured utilizing quantitative and qualitative radiographic assessments as applicable |
| Primary Effectiveness Assessment | Intra-operative to up to 10-years Post-Operative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Effectiveness Assessments: Work and Activity status | Pre-Operative to up to 10-years Post-Operative | 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. |
| Secondary Effectiveness Assessments: Patient Satisfaction | Pre-Operative to up to 10-years Post-Operative | 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). |
| Secondary Safety Assessments: Additional required medical treatments and/or supplemental surgical procedure | Pre-Operative to up to 10-years Post-Operative | 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. |
| Secondary Effectiveness Assessments: Duration of Hospital stay | Pre-Operative to up to 10-years Post-Operative | Length of hospital stay |
| Secondary Safety Assessments: Device and/or procedure-related deficiencies | Pre-Operative to up to 10-years Post-Operative | 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 |
| Secondary Effectiveness Assessments: Duration of Surgery | Pre-Operative to up to 10-years Post-Operative | Surgery time |
| Secondary Effectiveness Assessments: Quality of Life assessment | Pre-Operative to up to 10-years Post-Operative | 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 |
| Secondary Effectiveness Assessments: Changes in neurological function | Pre-Operative to up to 10-years Post-Operative | 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. |
Countries
Germany, South Africa, Spain, United States
Outcome results
None listed