Spinal Disorders/InjuriesRWE SpineNCT05082090
A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
An observational study of Spinal Disorders/Injuries, run by Orthofix Inc. at 20 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Disorders/Injuries
- What is being tested?
- Spinal Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 15 Sep 2021to Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United States9 sites
Lanman Spinal Neurosurgery
Beverly Hills, California, 90210
RasouliSpine
Beverly Hills, California, 90211
Columbus Orthopaedic
Columbus, Mississippi, 39705
M3 Emerging Medical Research
Durham, North Carolina, 27704
University Orthopedics
East Providence, Rhode Island, 02914
Acadiana Neurosurgery
Lafayette, Louisiana, 70508
Summit Brain, Spine and Orthopedics
Lehi, Utah, 84043
Tuckahoe Orthopedics
Richmond, Virginia, 23226
Neurosurgical Medical Clinic
San Diego, California, 92111
Germany5 sites
Marien-Krankenhaus Bergisch Gladbach
Bergisch Gladbach
Stenum Ortho GmbH
Ganderkesee, 27777
Praxis für Neurochirurgie-Chirotherapie
Nordhausen
Orthopädikum Potsdam
Potsdam, 14482
Krankenhaus Maria-Hilf Stadtlohn
Stadtlohn
Spain4 sites
Hospital Clínic de Barcelona
Barcelona
Hospital Vall d'Hebron
Barcelona
Hospital Universitario Son Espases
Palma de Mallorca
University Hospital Marqués de Valdecilla
Santander
South Africa2 sites
The Club Surgical Centre
Pretoria
Zuid-Afrikaans Hospital
Pretoria
About this study
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.
- Conditions
- Spinal Disorders/Injuries
- Being tested
- Spinal Surgery
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal SurgeryProcedure or surgery
Implanted with Orthofix Spinal products
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Spinal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Assessment: Device or procedure related adverse events
Evaluation of device related or procedure related adverse events
Measured: 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
Measured: 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."
Measured: 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.
Measured: Intra-operative to up to 10-years Post-Operative
Secondary outcomes (8)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Duration of Surgery
Surgery time
Measured: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Duration of Hospital stay
Length of hospital stay
Measured: 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
Measured: Pre-Operative to up to 10-years Post-Operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2021
- Study start15 Sep 2021
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Disorders/InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cahit Akbas, Study director, Global Clinical Program Manager
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082090
- Sponsor's protocol ID
- CP-2001SPPM
- Acronym
- RWE Spine
- Status last verified
- Jul 2025
- First submitted
- 21 Sep 2021
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
- ClinicalTrials.gov ID
- NCT05082090
- Acronym / sponsor ID
- RWE Spine / CP-2001SPPM
- Conditions
- Spinal Disorders/Injuries
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 18 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implanted with Orthofix Spinal products | – | Procedure: Spinal SurgeryStudy 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal SurgeryImplanted with Orthofix Spinal products | Procedure or surgery | Implanted with Orthofix Spinal products |
Primary outcome
Primary Safety Assessment: Device or procedure related adverse events
Time frame: 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
Time frame: Intra-operative to up to 10-years Post-Operative
Fusion status measured utilizing quantitative and qualitative radiographic assessments as applicable
Primary Effectiveness Assessment
Time frame: 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."
Primary Effectiveness Assessment
Time frame: 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.
8 secondary outcomes
Secondary Safety Assessments: Additional required medical treatments and/or supplemental surgical procedure
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Quality of Life assessment
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Changes in neurological function
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Work and Activity status
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Patient Satisfaction
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Duration of Surgery
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Effectiveness Assessments: Duration of Hospital stay
Time frame: Pre-Operative to up to 10-years Post-Operative
Secondary Safety Assessments: Device and/or procedure-related deficiencies
Time frame: Pre-Operative to up to 10-years Post-Operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cahit Akbas study director
Global Clinical Program Manager
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Disorders/Injuries, run by Orthofix Inc. at 20 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Germany, Spain, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Assessment: Device or procedure related adverse events (time frame: Pre-Operative to up to 10-years Post-Operative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.