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

The objectives of this study are to evaluate:

• Healing/union rates following joint fixation using the SpeedPlate™ Rapid Compression Implants
• Whether early weight-bearing (WB) following joint fixation using the SpeedPlate™ Rapid Compression Implants affects the healing/union rates
• Quality of life, pain scores and patient satisfaction following joint arthrodesis using the SpeedPlate™ Rapid Compression Implants

Inclusion criteria

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 criteria

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.