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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeedPlate™ Rapid Compression Implants | Device | MTP and/or TMT joint fixation with SpeedPlate™ Rapid Compression Implants |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Intermetatarsal Angle | Evaluate change in radiographic angular/positional alignment of the Intermetatarsal Angle - (IMA) before and after Index. | 6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months |
| Evaluate the Hallux Valgus Angle |
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Inclusion Criteria:
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:
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Patients 14 years of age or older that have had MTP and/or TMT joint fixation with the SpeedPlate™ Rapid Compression Implants.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Decatur Orthopaedic Clinic | Decatur | Alabama | 35601 | United States | ||
| Orlando Foot and Ankle Clinic |
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| ID | Term |
|---|---|
| D000844 | Ankylosis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Evaluate change in radiographic angular/positional alignment of the Hallux Valgus Angle (HVA) before and after Index.
| 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. | 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. | 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. | Days after surgery - on average up to 6 weeks |
| Evaluate time to start unrestricted activity. | Time to return to full unrestricted activity, in days. | 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". | 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". | 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". | 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. | 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):
| 24 Months |
| Orlando |
| Florida |
| 32825 |
| United States |
| JCMG - Podiatry | Jefferson City | Missouri | 65101 | United States |
| Ohio Foot and Ankle Center | Stow | Ohio | 44224 | United States |
| Foot and Ankle Associates of North Texas | Keller | Texas | 76248 | United States |