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NCT05856370 · ClinicalTrials.gov registry record · NA
The Ailliance Post-Market Clinical Study
A NA study of Spinal Deformity and Spinal Degenerative Disorder, sponsored by Medtronic Spinal and Biologics.
- Recruiting
- Registry status
- NA
- Development phase
- 1,000
- Enrollment target
- 20
- Study locations
NCT05856370: Recruiting NA study of Spinal Deformity and Spinal Degenerative Disorder, sponsored by Medtronic Spinal and Biologics.
NCT05856370 is a NA study of Spinal Deformity and Spinal Degenerative Disorder that is actively recruiting participants, run by Medtronic Spinal and Biologics. The registered enrollment target is 1,000 participants, above the 480-participant average among 7 other Spinal Deformity trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05856370, a NA study of Spinal Deformity and Spinal Degenerative Disorder, is actively recruiting participants, sponsored by Medtronic Spinal and Biologics.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,000 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Defined by amount of: 1) blood loss (mL) during surgery and/or 2) total operation time and/or 3) length of stay in the hospital (measured from surgery completion to discharge), and/or 4) investigator opinion on whether the device(s) directly assisted in the completion of surgery
Conditions Studied
Interventions
- DEVICE Follow-up schedule: pre-operative baseline up to 24-months post-procedure
Study Locations (20)
Indiana
- Indiana University School of Medicine - Bloomington
- Indiana Spine Group - Carmel
- The Orthopaedic Research Foundation (OrthoIndy) - Indianapolis
California
- University of California Davis Medical Center - Sacramento
- University of California, San Francisco (UCSF) - San Francisco
Missouri
- Washington University School of Medicine - St Louis
- Washington University School of Medicine - St Louis
Arizona
- University of Arizona - Tucson
Arkansas
- OrthoArkansas - Little Rock
Kentucky
- Norton Leatherman Spine Specialists - Louisville
Maryland
- University of Maryland Medical Center - Baltimore
Michigan
- Michigan Orthopaedic & Spine Surgeons - Rochester Hills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,000 participants |
| Start Date | 2023-05-01 |
| Est. Completion | 2031-05 |
| Phase | NA |
What NCT05856370 shows while recruiting
NCT05856370 is an interventional study that assigns participants to a tested intervention. Its 1,000 participants enrollment target places it among the larger protocols in the corpus, above the 480-participant average among 7 other Spinal Deformity trials with a reported enrollment target (108% higher).
The record links to 5 conditions, with Spinal Deformity appearing as the primary indexed condition, and to 1 intervention - of which Follow-up schedule: pre-operative baseline up to 24-months post-procedure is the first listed.
NCT05856370 names 20 study sites across 16 states, led by Indiana, California, Missouri.
Frequently Asked Questions
What is clinical trial NCT05856370 about?
NCT05856370 is a clinical study titled "The Ailliance Post-Market Clinical Study". 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 ...
What is the current status of trial NCT05856370?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,000 participants. The study started on 2023-05-01. Estimated completion is 2031-05.
What conditions does trial NCT05856370 study?
This clinical trial studies the following conditions: Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma, Spinal Tumor Case.
What interventions are being tested in trial NCT05856370?
The interventions under investigation include: Follow-up schedule: pre-operative baseline up to 24-months post-procedure (DEVICE).
Who is sponsoring clinical trial NCT05856370?
This trial is sponsored by Medtronic Spinal and Biologics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05856370 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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