The Ailliance Post-Market Clinical Study: All enablIng technoLogies,bioLogics, IDS, And core spiNe produCt collEction
Study of Safety and Performance of Investigational Devices for Conditions Related to the Skull and Backbone
David Stockwell
Primary Investigator
Brief description of study
Detailed description of study
The following is a list that outlines all the potential timepoints. The specific visits to be completed are dependent on the product group, as follows:
• Preoperative baseline visit
• Index surgery
• Discharge
• 1-month postoperative visit (30 ± 7 days)
• 3-month postoperative visit (91± 14 days) (optional visit per the
discretion of the investigator)
• 6-month postoperative visit (182 ± 30 days)
• 12-month postoperative visit (365 ± 91 days)
• 24-month (730 ± 91 days)
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma, Spinal Tumor
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria:
- Subject provides written informed consent per institution and/or geographical requirements.
- Subject is intended to receive or be treated with an eligible Medtronic Cranial and Spinal Technology (CST) device(s) (see product appendices), used alone or in combination, for a cranial and/or spinal indication(s).
- Subject is at least 18 years of age or minimum legal age as required by local regulations.
- Subject agrees to complete all required assessments per the Schedule of Events.
Exclusion Criteria:
- Subject is currently enrolled or plans to enroll in concurrent drug/device/biologic trial(s) that may confound this trial's results per investigator assessment (i.e. no required intervention that could affect interpretation of all-around device safety and or performance).
- Subject who is, or is expected to be, inaccessible for all required follow-up visits.
- Subject with exclusion criteria required by local law.
- Subject is considered vulnerable at the time of obtaining consent.
This study investigates the safety and performance of investigational devices for cranial and spinal conditions. The purpose is to collect clinical evidence about how these devices work and ensure they are safe for patients. These devices are used to treat conditions related to the brain and spine, which are important parts of the body responsible for many functions.
Participants in the study will go through several procedures, including surgeries and follow-up visits. The study will observe how the devices perform during and after these procedures to ensure they are working correctly and safely. The study will gather information at different times, such as before surgery, after surgery, and during follow-up visits.
- Who can participate: Adults 18 years and older scheduled to receive a specific investigational device for conditions related to the skull or backbone may participate. Participants must agree to complete all study assessments and cannot be part of another conflicting trial.
- Study details: Participants will undergo procedures involving investigational devices for conditions related to the skull or backbone. They must attend follow-up visits to monitor device performance and safety.
- Study visits: The study requires 7 visits.
