RecruitingNot Applicable

The Ailliance Post-Market Clinical Study

United States1,000 participantsStarted 2023-05-01

Plain-language summary

The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months. The Ailliance clinical study is intended to collect data congruous with routine clinical care practices.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)

Timeframe: Discharge (from Index Surgery completion to 14 days post-operatively)

Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)

Timeframe: 12 months

Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)

Timeframe: Index Surgery

Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)

Timeframe: 24 months

Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)

Timeframe: 12 months

Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)

Timeframe: Up to 12 months

Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers)

Timeframe: 12 months

Trial details

NCT IDNCT05856370

SponsorMedtronic Spinal and Biologics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-05

Contact for this trial

Lauren Oien

+17635268124 lauren.k.oien@medtronic.com

View on ClinicalTrials.gov More Spinal Deformity trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Surgical success (for any Medtronic eligible market-released Advanced Energy device(s) used)

Timeframe: Discharge (from Index Surgery completion to 14 days post-operatively)

Fusion Success (for any Medtronic eligible market-released Interbodies and Biologics, Other Spinal Hardware, and/or Rods and Screws device(s) used)

Timeframe: 12 months

Surgical performance (for any Medtronic eligible market-released Powered Systems, Instruments, and Imaging device(s) used)

Timeframe: Index Surgery

Device performance (for any Medtronic eligible market-released Robotics and Navigation device(s) used)

Timeframe: 24 months

Pain Resolution (for select Medtronic eligible market-released Other Spinal Hardware device(s) used)

Timeframe: 12 months

Stabilization (for any Medtronic eligible market-released device(s) used from the following product groups: Other Spinal Hardware)

Timeframe: Up to 12 months

Deformity Correction (for specified Medtronic eligible market-released device(s) used from the following product groups: Spinal Tethers)

Timeframe: 12 months