Clinical trial NCT06548581: The SpeedPlate™ Rapid Compression Implant Study (The SPRINT™ Study)
Official title: Radiographic and Patient Reported Outcomes Following Joint Arthrodesis Following the Use of the SpeedPlate™ Rapid Compression Implants: An Ambidirectional Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Joint Arthrodesis
Joint Fixation
Lead sponsor: Treace Medical Concepts, Inc.
Sponsor class: INDUSTRY
First posted: 2024-08-12
Enrollment: 92
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

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

Eligibility criteria: Inclusion Criteria:

Patients satisfying the following criteria will be considered and eligible for participation:

1. Patients who have had MTP and/or TMT joint fixation using at least one SpeedPlate™ Rapid Compression Implant (Index Procedure);
2. Males and females ages 14 years of age or older at the time of the Index Procedure;
3. Patients who have completed at least their 6-week post-operative visit but have not yet completed their 12-month post-operative visit;
4. Adequate pre-operative AP and lateral weight-bearing radiographs collected within 6 months of the Index Procedure;
5. Patients must be capable of completing self-administered questionnaires;
6. Willing and able to provide written informed consent.

Exclusion Criteria:

Patients satisfying the following criteria will not be eligible for participation:

1. Female patients of childbearing potential with positive pregnancy result at time of consent;
2. Unwilling or unable to schedule and return for follow-up visits;
3. Surgery for MTP or TMT joint arthrodesis on operative foot prior to Index Procedure;
4. Joint arthrodesis using other plating constructs in addition to the SpeedPlate™ Implant(s) at MTP or TMT joint at the time of Index Procedure;
5. 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);
6. Clinically significant neuropathy at time of Index Procedure;
7. Untreated Moderate - Severe Osteoarthritis of 1st, 2nd, or 3rd TMT or MTP during the Index Procedure;
8. 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;
9. BMI \>40 kg/m² at time of Index Procedure;
10. Use of structural bone graft during the Index Procedure;
11. Additional concomitant procedure during the Index Procedure that would have altered patient's ability to early weight-bear post-procedure.
12. Patient is actively involved with a workman's compensation case or is currently involved in litigation;
13. 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;
14. 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.

Primary outcomes:
measure: Evaluate union vs non-union
timeFrame: 12 Months
Secondary outcomes:
measure: Evaluate the Intermetatarsal Angle
timeFrame: 6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months
measure: Evaluate the Hallux Valgus Angle
timeFrame: 6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months
measure: Evaluate the Tibial Sesamoid
timeFrame: 6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months
measure: Evaluate time to start weight-bearing in a boot.
timeFrame: Days after surgery - on average up to 2 weeks
measure: Evaluate time to start weight-bearing in shoes.
timeFrame: Days after surgery - on average up to 6 weeks
measure: Evaluate time to start unrestricted activity.
timeFrame: Days after surgery - on average up to 4 months
measure: Evaluate patient-reported pain, post surgery.
timeFrame: 6 Months, 12 Months, 24 Months
measure: Evaluate patient-reported quality of life, post surgery.
timeFrame: 6 Months, 12 Months, 24 Months
measure: Evaluate patient-reported satisfaction, post surgery.
timeFrame: 12 Months, 24 Months
measure: Evaluate non-surgical clinical complications or health conditions that could affect outcomes related to the implants or procedure.
timeFrame: 24 Months
measure: Evaluate surgical clinical complications or health conditions that could affect outcomes related to the implants or procedure.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Decatur Orthopaedic Clinic
state: Alabama
city: Orlando
country: United States
facility: Orlando Foot and Ankle Clinic
state: Florida
city: Jefferson City
country: United States
facility: JCMG - Podiatry
state: Missouri
city: Stow
country: United States
facility: Ohio Foot and Ankle Center
state: Ohio
city: Keller
country: United States
facility: Foot and Ankle Associates of North Texas
state: Texas
Study officials:
References: