Clinical trial NCT05082090: A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
Official title: A Multi-Center Post-Market Data Collection Protocol to Evaluate the Performance of Orthofix Spine Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Spinal Disorders/Injuries
Lead sponsor: Orthofix Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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. 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.


Eligibility 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.

Primary outcomes:
measure: Primary Safety Assessment: Device or procedure related adverse events
timeFrame: Pre-Operative to up to 10-years Post-Operative
measure: Primary Effectiveness Assessments: Fusion status measured radiographs
timeFrame: Intra-operative to up to 10-years Post-Operative
measure: Primary Effectiveness Assessment
timeFrame: Intra-operative to up to 10-years Post-Operative
measure: Primary Effectiveness Assessment
timeFrame: Intra-operative to up to 10-years Post-Operative
Secondary outcomes:
measure: Secondary Safety Assessments: Additional required medical treatments and/or supplemental surgical procedure
timeFrame: Pre-Operative to up to 10-years Post-Operative
measure: Secondary Effectiveness Assessments: Quality of Life assessment
timeFrame: Pre-Operative to up to 10-years Post-Operative
measure: Secondary Effectiveness Assessments: Changes in neurological function
timeFrame: Pre-Operative to up to 10-years Post-Operative
measure: Secondary Effectiveness Assessments: Work and Activity status
timeFrame: Pre-Operative to up to 10-years Post-Operative
measure: Secondary Effectiveness Assessments: Patient Satisfaction
timeFrame: Pre-Operative to up to 10-years Post-Operative
measure: Secondary Effectiveness Assessments: Duration of Surgery
timeFrame: Pre-Operative to up to 10-years Post-Operative
measure: Secondary Effectiveness Assessments: Duration of Hospital stay
timeFrame: Pre-Operative to up to 10-years Post-Operative
measure: Secondary Safety Assessments: Device and/or procedure-related deficiencies
timeFrame: Pre-Operative to up to 10-years Post-Operative
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Lanman Spinal Neurosurgery
state: California
city: Beverly Hills
country: United States
facility: RasouliSpine
state: California
city: San Diego
country: United States
facility: Neurosurgical Medical Clinic
state: California
city: Lafayette
country: United States
facility: Acadiana Neurosurgery
state: Louisiana
city: Columbus
country: United States
facility: Columbus Orthopaedic
state: Mississippi
city: Durham
country: United States
facility: M3 Emerging Medical Research
state: North Carolina
city: East Providence
country: United States
facility: University Orthopedics
state: Rhode Island
city: Lehi
country: United States
facility: Summit Brain, Spine and Orthopedics
state: Utah
city: Richmond
country: United States
facility: Tuckahoe Orthopedics
state: Virginia
city: Bergisch Gladbach
country: Germany
facility: Marien-Krankenhaus Bergisch Gladbach
city: Ganderkesee
country: Germany
facility: Stenum Ortho GmbH
city: Nordhausen
country: Germany
facility: Praxis für Neurochirurgie-Chirotherapie
city: Potsdam
country: Germany
facility: Orthopädikum Potsdam
city: Stadtlohn
country: Germany
facility: Krankenhaus Maria-Hilf Stadtlohn
city: Pretoria
country: South Africa
facility: The Club Surgical Centre
city: Pretoria
country: South Africa
facility: Zuid-Afrikaans Hospital
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
city: Santander
country: Spain
facility: University Hospital Marqués de Valdecilla
Study officials:
affiliation: Global Clinical Program Manager
name: Cahit Akbas
role: STUDY_DIRECTOR
References: