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

NCT06548581 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CP2024-1
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Joint Arthrodesis; Joint Fixation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Evaluate the Intermetatarsal Angle

  6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months

• Evaluate the Hallux Valgus Angle

  6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months

• Evaluate the Tibial Sesamoid

  6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months

• Evaluate time to start weight-bearing in a boot.

  Days after surgery - on average up to 2 weeks

• Evaluate time to start weight-bearing in shoes.

  Days after surgery - on average up to 6 weeks

Study Arms (1)

Patients who have had joint arthrodesis procedures using the SpeedPlate™ Rapid Compression Implants

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 inclusion and exclusion criteria established in the study protocol.

Device: SpeedPlate™ Rapid Compression Implants

Interventions

SpeedPlate™ Rapid Compression Implants DEVICE

MTP and/or TMT joint fixation with SpeedPlate™ Rapid Compression Implants

Patients who have had joint arthrodesis procedures using the SpeedPlate™ Rapid Compression Implants

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 14 years of age or older that have had MTP and/or TMT joint fixation with the SpeedPlate™ Rapid Compression Implants.

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.

Sponsors & Collaborators

• Treace Medical Concepts, Inc.: lead

Study Sites (5)

Decatur Orthopaedic Clinic

Decatur, Alabama, 35601, United States

Location

Orlando Foot and Ankle Clinic

Orlando, Florida, 32825, United States

Location

JCMG - Podiatry

Jefferson City, Missouri, 65101, United States

Location

Ohio Foot and Ankle Center

Stow, Ohio, 44224, United States

Location

Foot and Ankle Associates of North Texas

Keller, Texas, 76248, United States

Location

MeSH Terms

Conditions

Ankylosis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 12, 2024
• Study Start: September 4, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

US (5)