ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-09-15
Study Completion:2031-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05082090

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Patient is 18 years or older at the time of surgery.
  3. 3. Patient is capable of understanding the content of the patient information / Informed Consent Form (ICF) for the prospective segment of the study.
  4. 4. Patient is willing and able to participate in the prospective data collection protocol and comply with the required data collection.
  1. 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.

Contacts and Locations

Principal Investigator

Cahit Akbas
STUDY_DIRECTOR
Global Clinical Program Manager

Study Locations (Sites)

Lanman Spinal Neurosurgery
Beverly Hills, California, 90210
United States
RasouliSpine
Beverly Hills, California, 90211
United States
Neurosurgical Medical Clinic
San Diego, California, 92111
United States
Acadiana Neurosurgery
Lafayette, Louisiana, 70508
United States
Columbus Orthopaedic
Columbus, Mississippi, 39705
United States
M3 Emerging Medical Research
Durham, North Carolina, 27704
United States
University Orthopedics
East Providence, Rhode Island, 02914
United States
Summit Brain, Spine and Orthopedics
Lehi, Utah, 84043
United States
Tuckahoe Orthopedics
Richmond, Virginia, 23226
United States

Collaborators and Investigators

Sponsor: Orthofix Inc.

  • Cahit Akbas, STUDY_DIRECTOR, Global Clinical Program Manager

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-09-15
Study Completion Date2031-12

Study Record Updates

Study Start Date2021-09-15
Study Completion Date2031-12

Terms related to this study

Additional Relevant MeSH Terms

  • Spinal Disorders/Injuries