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The SpeedPlate™ Rapid Compression Implant Study (The SPRINT™ Study)

Study acronym: SPRINT™
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 11, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Enrolling by Invitation to Active, Not Recruitingv9 Show 4 more changesShow less
    • Enrollment target: estimated 200 to confirmed 92
    • Study sites: 6 to 5
    • Primary completion date: Sep 2026 to Mar 2026
    • Study completion date: Sep 2028 to Dec 2026
  2. Study sites: 7 to 6v8
  3. Re-verified, no change to tracked fieldsv7
  4. Study sites: 6 to 7v6
  5. Eligibility criteria expanded, about 18 wordsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 5 to 6
    • Start date changed from estimate of Sep 2024 to Sep 4, 2024
    v4
  2. Study sites: 2 to 5v3
  3. Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Study sites: 0 to 2
    • Primary completion date: Aug 2026 to Sep 2026
    • Study completion date: Aug 2028 to Sep 2028
    • Start date: Aug 2024 to Sep 2024
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06548581
Lead Sponsor Treace Medical Concepts, Inc.
Conditions
(from sponsor)		 Joint Arthrodesis, Joint Fixation
Related terms Ankylosis
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov