The SpeedPlate™ Rapid Compression Implant Study (The SPRINT™ Study)
NCT Number: NCT06548581
Acronym: SPRINT™
Status: ENROLLING_BY_INVITATION
Study Type: OBSERVATIONAL
Conditions: Joint Arthrodesis|Joint Fixation
Sponsor: Treace Medical Concepts, Inc.
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09
Completion Date: 2028-09

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 through 65 years 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 Measures: Evaluate union vs non-union, 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., 12 Months
Secondary Outcome Measures: Evaluate the Intermetatarsal Angle, Evaluate change in radiographic angular/positional alignment of the Intermetatarsal Angle - (IMA) before and after Index., 6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months|Evaluate the Hallux Valgus Angle, Evaluate change in radiographic angular/positional alignment of the Hallux Valgus Angle (HVA) before and after Index., 6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months|Evaluate the Tibial Sesamoid, Evaluate change in radiographic angular/positional alignment of the Tibial Sesamoid Position (TSP) before and after Index., 6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months|Evaluate time to start weight-bearing in a boot., Time to start of weight-bearing in boot, in days., Days after surgery - on average up to 2 weeks|Evaluate time to start weight-bearing in shoes., Time to start of weight-bearing in shoes, in days., Days after surgery - on average up to 6 weeks|Evaluate time to start unrestricted activity., Time to return to full unrestricted activity, in days., Days after surgery - on average up to 4 months|Evaluate patient-reported pain, post surgery., Reported pain via Visual Analog Scale (VAS) at 6-, 12- and 24-months post-procedure. The VAS pain scale is measured from 0-10 with 0 being "pain free" to 10 being "unconscious - pain makes you pass out"., 6 Months, 12 Months, 24 Months|Evaluate patient-reported quality of life, post surgery., Quality of Life (Manchester-Oxford Foot Questionnaire) defined as the total domain score measured at 6-, 12- and 24-months post-procedure. The MOxFQ is a series of 16 quality of life questions related to a patient's foot - from pain, appearance, and functionality. Answers range from "none of the time to all of the time", "none to severe" and "no nights to every night"., 6 Months, 12 Months, 24 Months|Evaluate patient-reported satisfaction, post surgery., Post-Operative Patient Satisfaction at 12- and 24-months post-procedure. The Post-Op Patient Satisfaction questionnaire asks a series of 10 quality of life questions related to the patient's surgical and recovery experience as related to: pain, function, foot alignment, and foot aesthetics. The answers range mostly from "better, worse, same" and "satisfied, unsatisfied"., 12 Months, 24 Months|Evaluate non-surgical clinical complications or health conditions that could affect outcomes related to the implants or procedure., Percentage of participants experiencing at least one clinical complication related to the SpeedPlate™ Rapid Compression Implants, to the joint arthrodesis procedure, or to other health conditions that could affect outcome measures and not requiring surgical intervention through the 24-month post-operative visit., 24 Months|Evaluate surgical clinical complications or health conditions that could affect outcomes related to the implants or procedure., Percentage of participants experiencing at least one clinical complication related to the SpeedPlate™ Rapid Compression Implants, to the joint arthrodesis procedure, or to other health conditions that could affect outcome measures through the 24-month post-operative visit and requiring one or more of the following subsequent secondary surgical interventions (SSSI):

1. hardware removal (any reason, hardware not replaced)
2. revision of bone for delayed union or non-union (e.g. bone graft)
3. hardware failure (e.g. broken hardware) requiring supplemental fixation or hardware replacement
4. wound healing (hardware not replaced or removed)
5. infection at the surgical site (hardware not replaced or removed)
6. other complication requiring surgical intervention, 24 Months