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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05082090
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Orthofix Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Cahit Akbas
Principal Investigator Affiliation	Global Clinical Program Manager
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Germany, South Africa, Spain, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Spinal Disorders/Injuries

Arms & Interventions

Arms

: 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)

Interventions

Procedure: - Spinal Surgery

Implanted with Orthofix Spinal products

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Lanman Spinal Neurosurgery, Beverly Hills, California

Status

Enrolling by invitation

Address

Lanman Spinal Neurosurgery

Beverly Hills, California, 90210

Site Contact

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