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

NCT05082090 | Active Not Recruiting

• 1 other identifier: CP-2001SPPM
• Study Type: observational
• Target: 2,000
• Locations: 4 countries
• Sites: 20

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.

Conditions

Spinal Disorders/Injuries

Outcome Measures

Primary Outcomes (4)

• Primary Safety Assessment: Device or procedure related adverse events

  Evaluation of device related or procedure related adverse events

  Pre-Operative to up to 10-years Post-Operative

• Primary Effectiveness Assessments: Fusion status measured radiographs

  Fusion status measured utilizing quantitative and qualitative radiographic assessments as applicable

  Intra-operative to up to 10-years Post-Operative

• Primary Effectiveness Assessment

  Improvement in pain measured with Visual Analogue Scale (VAS) or Numeric Rating Scale (NRS): NRS is an 11-point scale for patient self-reporting of pain. Patients rate their current pain intensity at the time of the visit from 0 ("no pain") to 10 ("worst possible pain") by selecting a number on a horizontal bar. NRS scores for the evaluation of pain have been categorized as mild (1-3), moderate (4-6), or severe (7-10). VAS scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  Intra-operative to up to 10-years Post-Operative

• Primary Effectiveness Assessment

  Improvement in function as measured with Neck Disability Index (NDI) or Oswestry Disability Index (ODI). NDI includes 4 items that relate to subjective symptomatology (pain severity, headache, concentration, sleeping) and 6 items that relate to activities of daily living (lifting, work, driving, recreation, personal care, reading). Each item is scored from 0 to 5, with higher scores corresponding to greater disability. A total NDI score is determined by adding the scores of the individual questions and dividing that total by the maximum possible score (i.e., 50 if all questions are answered) to yield a percentage. Therefore, the NDI score ranges from 0 to 100. The ODI was developed as a specific outcomes tool for subjects suffering from back pain. The questionnaire scores 10 aspects of the subject's home and work life and analgesic use. The disability index is then calculated as a percentage with a high percentage indicating a high level of disability.

  Intra-operative to up to 10-years Post-Operative

Secondary Outcomes (8)

• Secondary Safety Assessments: Additional required medical treatments and/or supplemental surgical procedure

  Pre-Operative to up to 10-years Post-Operative

• Secondary Effectiveness Assessments: Quality of Life assessment

  Pre-Operative to up to 10-years Post-Operative

• Secondary Effectiveness Assessments: Changes in neurological function

  Pre-Operative to up to 10-years Post-Operative

• Secondary Effectiveness Assessments: Work and Activity status

  Pre-Operative to up to 10-years Post-Operative

• Secondary Effectiveness Assessments: Patient Satisfaction

  Pre-Operative to up to 10-years Post-Operative

Study Arms (1)

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)

Procedure: Spinal Surgery

Interventions

Spinal Surgery PROCEDURE

Implanted with Orthofix Spinal products

Implanted with Orthofix Spinal products

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient diagnosed with a spine injury/disorder and undergoing or has undergone spine procedure at the participating investigative centers utilizing Orthofix Spine devices.
• Patient is 18 years or older at the time of surgery.
• Patient is capable of understanding the content of the patient information / Informed Consent Form (ICF) for the prospective segment of the study.
• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Orthofix Inc.: lead

Study Sites (20)

Lanman Spinal Neurosurgery

Beverly Hills, California, 90210, United States

Location

RasouliSpine

Beverly Hills, California, 90211, United States

Location

Neurosurgical Medical Clinic

San Diego, California, 92111, United States

Location

Acadiana Neurosurgery

Lafayette, Louisiana, 70508, United States

Location

Columbus Orthopaedic

Columbus, Mississippi, 39705, United States

Location

M3 Emerging Medical Research

Durham, North Carolina, 27704, United States

Location

University Orthopedics

East Providence, Rhode Island, 02914, United States

Location

Summit Brain, Spine and Orthopedics

Lehi, Utah, 84043, United States

Location

Tuckahoe Orthopedics

Richmond, Virginia, 23226, United States

Location

Marien-Krankenhaus Bergisch Gladbach

Bergisch Gladbach, Germany

Location

Stenum Ortho GmbH

Ganderkesee, 27777, Germany

Location

Praxis für Neurochirurgie-Chirotherapie

Nordhausen, Germany

Location

Orthopädikum Potsdam

Potsdam, 14482, Germany

Location

Krankenhaus Maria-Hilf Stadtlohn

Stadtlohn, Germany

Location

The Club Surgical Centre

Pretoria, South Africa

Location

Zuid-Afrikaans Hospital

Pretoria, South Africa

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitario Son Espases

Palma de Mallorca, Spain

Location

University Hospital Marqués de Valdecilla

Santander, Spain

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Cahit Akbas

  Global Clinical Program Manager

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 18, 2021
• Study Start: September 15, 2021
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4); DE (5); US (9); ZA (2)