An observational study in Joint Arthrodesis and Joint Fixation, sponsored by Treace Medical Concepts, Inc.. Active, not recruiting at 5 sites in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-11.
Sponsored by Treace Medical Concepts, Inc. · Observational
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.
The objectives of this study are to evaluate:
83 studies on the registry are indexed under Ankylosis; 18 are open to participants now.
This study's enrollment of 92 is below the median of 103 across 46 observational studies indexed under Ankylosis.
Browse Ankylosis studies →Treace Medical Concepts, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients 14 years of age or older that have had MTP and/or TMT joint fixation with the SpeedPlate™ Rapid Compression Implants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients satisfying the following criteria will be considered and eligible for participation:
Exclusion Criteria:
Patients satisfying the following criteria will not be eligible for participation:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
MTP and/or TMT joint fixation with SpeedPlate™ Rapid Compression Implants
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.
Time frame: 12 Months
Evaluate the Intermetatarsal Angle
Evaluate change in radiographic angular/positional alignment of the Intermetatarsal Angle - (IMA) before and after Index.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Days after surgery - on average up to 6 weeks
Evaluate time to start unrestricted activity.
Time to return to full unrestricted activity, in days.
Time frame: 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".
Time frame: 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".
Time frame: 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".
Time frame: 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.
Time frame: 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
Time frame: 24 Months
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Treace Medical Concepts, Inc.