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

Running, not enrolling

Conditions studied: Joint Arthrodesis, Joint Fixation

In brief

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.

Key facts

Study ID: NCT06548581
Run by: Treace Medical Concepts, Inc.
People needed: 92
Starts: 2024-09-04
Expected to finish: 2026-12-01
Last updated by the study team: 2025-06-11

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Patients satisfying the following criteria will be considered and eligible for participation:
Patients who have had MTP and/or TMT joint fixation using at least one SpeedPlate™ Rapid Compression Implant (Index Procedure);
Males and females ages 14 years of age or older at the time of the Index Procedure;
Patients who have completed at least their 6-week post-operative visit but have not yet completed their 12-month post-operative visit;
Adequate pre-operative AP and lateral weight-bearing radiographs collected within 6 months of the Index Procedure;
Patients must be capable of completing self-administered questionnaires;
Willing and able to provide written informed consent.

You may not qualify if…

Patients satisfying the following criteria will not be eligible for participation:
Female patients of childbearing potential with positive pregnancy result at time of consent;
Unwilling or unable to schedule and return for follow-up visits;
Surgery for MTP or TMT joint arthrodesis on operative foot prior to Index Procedure;
Joint arthrodesis using other plating constructs in addition to the SpeedPlate™ Implant(s) at MTP or TMT joint at the time of Index Procedure;
Surgeries on operative foot involving fusion of the foot or ankle joints prior to, or at the time of, Index Procedure (other than hammertoe or lesser toes/digits);
Clinically significant neuropathy at time of Index Procedure;
Untreated Moderate - Severe Osteoarthritis of 1st, 2nd, or 3rd TMT or MTP during the Index Procedure;
Untreated Moderate - Severe Osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd TMT or MTP joints at the time of Index Procedure;
BMI >40 kg/m² at time of Index Procedure;
Use of structural bone graft during the Index Procedure;
Additional concomitant procedure during the Index Procedure that would have altered patient's ability to early weight-bear post-procedure.
Patient is actively involved with a workman's compensation case or is currently involved in litigation;
Patient is currently or has participated in a clinical study in the last 30 days prior to signing informed consent or is considering participation in another research protocol during this study; exceptions to this include survey clinical studies with no treatment or if participant is greater than 12 months post-procedure in either the Treace ALIGN3D™, Mini3D™ or MTA3D™ study without ongoing protocol defined adverse events;
Patient has a condition or finding that, in the opinion of the Investigator, may jeopardize the patient's well-being, the soundness of this clinical study, or could interfere with provision of informed consent, completion of tests, therapy, or follow-up.

Where it is running

Decatur Orthopaedic Clinic — Decatur, Alabama, United States
Orlando Foot and Ankle Clinic — Orlando, Florida, United States
JCMG - Podiatry — Jefferson City, Missouri, United States
Ohio Foot and Ankle Center — Stow, Ohio, United States
Foot and Ankle Associates of North Texas — Keller, Texas, United States

Full record on ClinicalTrials.gov

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