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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Spinal Disorders/Injuries
Intervention / Treatment

-

Contacts and Locations

Beverly Hills

Lanman Spinal Neurosurgery, Beverly Hills, California, United States, 90210

Beverly Hills

RasouliSpine, Beverly Hills, California, United States, 90211

San Diego

Neurosurgical Medical Clinic, San Diego, California, United States, 92111

Lafayette

Acadiana Neurosurgery, Lafayette, Louisiana, United States, 70508

Columbus

Columbus Orthopaedic, Columbus, Mississippi, United States, 39705

Durham

M3 Emerging Medical Research, Durham, North Carolina, United States, 27704

East Providence

University Orthopedics, East Providence, Rhode Island, United States, 02914

Lehi

Summit Brain, Spine and Orthopedics, Lehi, Utah, United States, 84043

Richmond

Tuckahoe Orthopedics, Richmond, Virginia, United States, 23226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Orthofix Inc.,

Cahit Akbas, STUDY_DIRECTOR, Global Clinical Program Manager

Study Record Dates

2031-12