Status:
ACTIVE_NOT_RECRUITING
The SpeedPlate™ Rapid Compression Implant Study (The SPRINT™ Study)
Lead Sponsor:
Treace Medical Concepts, Inc.
Conditions:
Joint Arthrodesis
Joint Fixation
Eligibility:
All Genders
14+ years
Brief 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 treate...
Detailed Description
The objectives of this study are to evaluate: 1. Healing/union rates following joint fixation using the SpeedPlate™ Rapid Compression Implants 2. Whether early weight-bearing (WB) following joint fix...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06548581
Start Date
September 4 2024
End Date
December 1 2026
Last Update
June 11 2025
Active Locations (5)
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1
Decatur Orthopaedic Clinic
Decatur, Alabama, United States, 35601
2
Orlando Foot and Ankle Clinic
Orlando, Florida, United States, 32825
3
JCMG - Podiatry
Jefferson City, Missouri, United States, 65101
4
Ohio Foot and Ankle Center
Stow, Ohio, United States, 44224