Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT05456633
Eligibility Criteria:
Inclusion Criteria:
* Skeletally mature
* Willingness and ability to comply with the requirements of the protocol including follow-up requirements
* Willing and able to sign a study specific informed consent form. For fully retrospective enrollments, i.e., subjects that already have 24-month follow-up data available, the Principal Investigator will request a waiver of the written informed consent requirement.
* Has undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) using either Capri Cervical 3D Static OR Capri Cervical 3D Expandable to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders -OR- Has undergone or will undergo VBR in the thoracolumbar spine (T1 to L5) using Capri Thoracolumbar Expandable to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture)
* Score at least 30 points on the ODI or at least 30 points on the NDI at screening (or before surgery for retrospective enrollment) (on a 100-point scale)
Exclusion Criteria:
* Presence of infection, except within the spinal indications for use of this product
* Pregnancy (pregnant at the time of enrollment or intends to become pregnant during the course of the study)
* Metabolic disorders of calcified tissues
* Grossly distorted anatomy
* Inadequate tissue coverage
* Drug / alcohol abuse
* Mental illness such as a psychiatric or cognitive impairment, that in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements or patient reported outcomes (e.g., Alzheimer's Disease)
* General neurological conditions
* Immunosuppressive disorders
* Subjects with known sensitivities to materials in the device
* Obesity defined as a BMI greater than 30
* Subjects who are unwilling to restrict activities or follow medical advice
* Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery
* Biological factors such as smoking, use of nonsteroidal anti-inflammatory agents, use of anticoagulants, etc.
* Subjects that adhere to the specified washout period detailed below can be enrolled: Smoking cessation must occur at a minimum of 4 weeks prior to surgery; Nonsteroidal anti-inflammatories (NSAIDs) should be stopped at a minimum of 7 days prior to surgery; Anticoagulants should be stopped at the discretion of the operating surgeon as the washout period varies for each medication
* Trauma subjects that are unable to adhere to the washout period can be enrolled; however, the aforementioned biological factors will need to be documented during data collection
* Prior fusion at the level(s) to be treated
* Incarcerated at the time of study enrollment
* Current participation in an investigational study that may impact study outcomes
* Involved in current or pending spinal litigation or a workman compensation claim
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05456633
Study Brief:
Protocol Section:
NCT05456633