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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Disorders/Injuries
• Intervention / Treatment: Procedure: Spinal Surgery

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• Germany
  • Bergisch Gladbach, Germany
    • Marien-Krankenhaus Bergisch Gladbach
  • Ganderkesee, Germany, 27777
    • Stenum Ortho GmbH
  • Nordhausen, Germany
    • Praxis für Neurochirurgie-Chirotherapie
  • Potsdam, Germany, 14482
    • Orthopädikum Potsdam
  • Stadtlohn, Germany
    • Krankenhaus Maria-Hilf Stadtlohn
• South Africa
  • Pretoria, South Africa
    • The Club Surgical Centre
  • Pretoria, South Africa
    • Zuid-Afrikaans Hospital
• Spain
  • Barcelona, Spain
    • Hospital Clinic De Barcelona
  • Barcelona, Spain
    • Hospital Vall D'Hebron
  • Palma De Mallorca, Spain
    • Hospital Universitario Son Espases
  • Santander, Spain
    • University Hospital Marqués de Valdecilla
• United States
  • California
    • Beverly Hills, California, United States, 90210
      • Lanman Spinal Neurosurgery
    • Beverly Hills, California, United States, 90211
      • RasouliSpine
    • San Diego, California, United States, 92111
      • Neurosurgical Medical Clinic
  • Louisiana
    • Lafayette, Louisiana, United States, 70508
      • Acadiana Neurosurgery
  • Mississippi
    • Columbus, Mississippi, United States, 39705
      • Columbus Orthopaedic
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • M3 Emerging Medical Research
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • University Orthopedics
  • Utah
    • Lehi, Utah, United States, 84043
      • Summit Brain, Spine and Orthopedics
  • Virginia
    • Richmond, Virginia, United States, 23226
      • Tuckahoe Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Both retrospective and prospective study subjects have spinal injuries/disorders requiring treatment with an Orthofix Spine device.

The three types of subject enrollment include:

1. Retrospective data collection only
2. Prospective data collection only
3. Retrospective and prospective data collection

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Implanted with Orthofix Spinal products; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Orthofix Inc.
• Investigators: Study Director: Cahit Akbas, Global Clinical Program Manager

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases
• Other Study ID Numbers: CP-2001SPPM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No