NCT06548581

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

Radiographic and Patient Reported Outcomes Following Joint Arthrodesis Following the Use of the SpeedPlate™ Rapid Compression Implants: An Ambidirectional Cohort Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 92 (actual)
• Sponsor: Treace Medical Concepts, Inc. · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

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.

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 fixation using the SpeedPlate™ Rapid Compression Implants affects the healing/union rates 3. Quality of life, pain scores and patient satisfaction following joint arthrodesis using the SpeedPlate™ Rapid Compression Implants

Conditions

• Joint Arthrodesis
• Joint Fixation

Interventions

Type	Name	Description
DEVICE	SpeedPlate™ Rapid Compression Implants	MTP and/or TMT joint fixation with SpeedPlate™ Rapid Compression Implants

Timeline

• Start date: 2024-09-04
• Primary completion: 2026-03-01
• Completion: 2026-12-01
• First posted: 2024-08-12
• Last updated: 2025-06-11

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study