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

Orthofix

Status: Active, not recruiting

Conditions: Spinal Disorders/Injuries

Treatments: Procedure: Spinal Surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT05082090

CP-2001SPPM

Details and patient eligibility

About

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

2,000 participants in 1 patient group

Implanted with Orthofix Spinal products

Description:

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)

Treatment:

Procedure: Spinal Surgery