An observational study in Spinal Disorders/Injuries, sponsored by Orthofix Inc.. Active, not recruiting at 20 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-30.
Sponsored by Orthofix Inc. · Observational
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Orthofix Inc. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Both retrospective and prospective study subjects have spinal injuries/disorders requiring treatment with an Orthofix Spine device.
The three types of subject enrollment include:
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.
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
Implanted with Orthofix Spinal products
Primary Safety Assessment: Device or procedure related adverse events
Evaluation of device related or procedure related adverse events
Time frame: 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
Time frame: 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."
Time frame: 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.
Time frame: Intra-operative to up to 10-years Post-Operative
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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Duration of Surgery
Surgery time
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Duration of Hospital stay
Length of hospital stay
Time frame: 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
Time frame: Pre-Operative to up to 10-years Post-Operative
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Orthofix Inc.