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NCT06548581 · ClinicalTrials.gov registry record
The SpeedPlate™ Rapid Compression Implant Study (The SPRINT™ Study)
A clinical trial of Joint Arthrodesis and Joint Fixation, sponsored by Treace Medical Concepts.
- Active
- Registry status
- 92
- Enrollment target
- 5
- Study locations
NCT06548581: Active study of Joint Arthrodesis and Joint Fixation, sponsored by Treace Medical Concepts.
NCT06548581 is a study of Joint Arthrodesis and Joint Fixation that is active but no longer recruiting, run by Treace Medical Concepts. The registered enrollment target is 92 participants. The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06548581, a study of Joint Arthrodesis and Joint Fixation, is active but no longer recruiting, sponsored by Treace Medical Concepts.
- ACTIVE NOT RECRUITING
- Registry status
- 92 participants
- Enrollment target
- 5
- Study locations
Study Summary
Post-market, observational, multicenter, unblinded, ambidirectional cohort study to evaluate outcomes of study participants treated with the SpeedPlate™ product. Up to 200 participants will be treated in this study at (up to) 15 clinical sites. Patients 14 years of age or older that have had MTP and/or TMT joint fixation with the SpeedPlate™ Rapid Compression Implants will be eligible to participate based on the inclusion and exclusion criteria defined in this protocol.
Primary Outcome
Evaluate clinical/radiographic healing (union vs non-unio). Non-union is defined as radiographic lucency and clinical pain at the 1st, 2nd, and/or 3rd TMT or MTP joint at 12 months post Index.
Conditions Studied
Interventions
- DEVICE SpeedPlate™ Rapid Compression Implants
Study Locations (5)
Alabama
- Decatur Orthopaedic Clinic - Decatur
Florida
- Orlando Foot and Ankle Clinic - Orlando
Missouri
- JCMG - Podiatry - Jefferson City
Ohio
- Ohio Foot and Ankle Center - Stow
Texas
- Foot and Ankle Associates of North Texas - Keller
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2024-09-04 |
| Est. Completion | 2026-12 |
What the registry record for NCT06548581 still lists
NCT06548581 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 92 participants, a relatively small participant target.
The record links to 2 conditions, with Joint Arthrodesis appearing as the primary indexed condition, and to 1 intervention - of which SpeedPlate™ Rapid Compression Implants is the first listed.
NCT06548581 lists 5 locations in 5 states (Alabama, Florida, Missouri).
Frequently Asked Questions
What is clinical trial NCT06548581 about?
NCT06548581 is a clinical study titled "The SpeedPlate™ Rapid Compression Implant Study (The SPRINT™ Study)". Post-market, observational, multicenter, unblinded, ambidirectional cohort study to evaluate outcomes of study participants treated with the SpeedPlate™ product. Up to 200 participants will be treated in this study at (up to) 15 clinical sites. Patients 14 years of age or older that have had MTP a...
What is the current status of trial NCT06548581?
This trial is currently active not recruiting. The enrollment target is 92 participants. The study started on 2024-09-04. Estimated completion is 2026-12.
What conditions does trial NCT06548581 study?
This clinical trial studies the following conditions: Joint Arthrodesis, Joint Fixation.
What interventions are being tested in trial NCT06548581?
The interventions under investigation include: SpeedPlate™ Rapid Compression Implants (DEVICE).
Who is sponsoring clinical trial NCT06548581?
This trial is sponsored by Treace Medical Concepts, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06548581 being conducted?
This trial has 5 study locations across Alabama, Florida, Missouri, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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