A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
- Conditions
- Spinal Disorders/Injuries
- Interventions
- Procedure: Spinal Surgery
- Registration Number
- NCT05082090
- Lead Sponsor
- Orthofix Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- 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.
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:
- 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.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Implanted with Orthofix Spinal products Spinal Surgery 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)
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method 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: 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: 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.
Secondary Effectiveness Assessments: Duration of Hospital stay Pre-Operative to up to 10-years Post-Operative Length of hospital stay
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: Duration of Surgery Pre-Operative to up to 10-years Post-Operative Surgery time
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
Trial Locations
- Locations (20)
Summit Brain, Spine and Orthopedics
🇺🇸Lehi, Utah, United States
RasouliSpine
🇺🇸Beverly Hills, California, United States
Acadiana Neurosurgery
🇺🇸Lafayette, Louisiana, United States
Lanman Spinal Neurosurgery
🇺🇸Beverly Hills, California, United States
Columbus Orthopaedic
🇺🇸Columbus, Mississippi, United States
University Orthopedics
🇺🇸East Providence, Rhode Island, United States
Stenum Ortho GmbH
🇩🇪Ganderkesee, Germany
Marien-Krankenhaus Bergisch Gladbach
🇩🇪Bergisch Gladbach, Germany
Praxis für Neurochirurgie-Chirotherapie
🇩🇪Nordhausen, Germany
Krankenhaus Maria-Hilf Stadtlohn
🇩🇪Stadtlohn, Germany
Orthopädikum Potsdam
🇩🇪Potsdam, Germany
The Club Surgical Centre
🇿🇦Pretoria, South Africa
Zuid-Afrikaans Hospital
🇿🇦Pretoria, South Africa
Hospital Universitario Son Espases
🇪🇸Palma De Mallorca, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
University Hospital Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Neurosurgical Medical Clinic
🇺🇸San Diego, California, United States
M3 Emerging Medical Research
🇺🇸Durham, North Carolina, United States
Tuckahoe Orthopedics
🇺🇸Richmond, Virginia, United States