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Joint ArthrodesisSPRINT™NCT06548581

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

An observational study of Joint Arthrodesis and Joint Fixation, run by Treace Medical Concepts, Inc. at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
Conditions the study is for
Joint Arthrodesis, Joint Fixation
What is being tested?
SpeedPlate™ Rapid Compression Implants
Type of treatment
Medical device
How many people
92 participants
Where
5 sitesUnited States
Study dates
4 Sep 2024to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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);
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  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Decatur Orthopaedic Clinic

    Decatur, Alabama, 35601

  • JCMG - Podiatry

    Jefferson City, Missouri, 65101

  • Foot and Ankle Associates of North Texas

    Keller, Texas, 76248

  • Orlando Foot and Ankle Clinic

    Orlando, Florida, 32825

  • Ohio Foot and Ankle Center

    Stow, Ohio, 44224

Other trials in United States

About this study

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

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.

Read the 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
Being tested
SpeedPlate™ Rapid Compression Implants
Medical subject headings
Ankylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpeedPlate™ Rapid Compression ImplantsDevice

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

Study groups in NCT06548581
Study groupRoleWhat they receive
Patients who have had joint arthrodesis procedures using the SpeedPlate™ Rapid Compression ImplantsPatients 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.
Receives: Device: SpeedPlate™ Rapid Compression Implants

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 12 Months

Secondary outcomes (11)

  1. Evaluate the Intermetatarsal Angle

    Evaluate change in radiographic angular/positional alignment of the Intermetatarsal Angle - (IMA) before and after Index.

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

  2. Evaluate the Hallux Valgus Angle

    Evaluate change in radiographic angular/positional alignment of the Hallux Valgus Angle (HVA) before and after Index.

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

  3. Evaluate the Tibial Sesamoid

    Evaluate change in radiographic angular/positional alignment of the Tibial Sesamoid Position (TSP) before and after Index.

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

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

    Time to start of weight-bearing in boot, in days.

    Measured: Days after surgery - on average up to 2 weeks

  5. Evaluate time to start weight-bearing in shoes.

    Time to start of weight-bearing in shoes, in days.

    Measured: Days after surgery - on average up to 6 weeks

  6. Evaluate time to start unrestricted activity.

    Time to return to full unrestricted activity, in days.

    Measured: Days after surgery - on average up to 4 months

  7. 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".

    Measured: 6 Months, 12 Months, 24 Months

  8. 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".

    Measured: 6 Months, 12 Months, 24 Months

  9. 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".

    Measured: 12 Months, 24 Months

  10. 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.

    Measured: 24 Months

  11. 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

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start4 Sep 2024
  3. Primary completionMar 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06548581
Sponsor's protocol ID
CP2024-1
Acronym
SPRINT™
Status last verified
Jun 2025
First submitted
29 Jul 2024
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Joint Arthrodesis and Joint Fixation, run by Treace Medical Concepts, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate union vs non-union (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06548581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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