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Post-market clinical follow-up study on the Monster Screw System
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monster Screw System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monster Screw System | Device | Subjects who have undergone a foot and/or ankle procedure involving the index device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of secondary procedures | Safety will be assessed by recording the incidence of secondary procedures related to the index procedure | Up to 9 months |
| Incidence of adverse events | Safety will be assessed by recording the incidence of adverse events | Up to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Nonunion | Safety as related to the rate of nonunion of the area treated with the index device | Up to 9 months |
| Rate of Maintenance of Correction | Safety as related to the rate of the maintenance of correction |
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Inclusion Criteria:
For the Prospective Data Collection:
- The subject is willing to provide written informed consent
Exclusion Criteria:
-None
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The investigational population will include subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jacy Legue | Paragon 28 | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health Systems | Jackson | Michigan | 49201 | United States |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| D018409 | Foot Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Up to 9 months |
| Rate of Index Device Failure | Safety as related to the rate of the failure of the index device | Up to 9 months |
| Foot and Ankle Mobility Measure | Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) subscale and current level of daily activity rating (0-100). The higher the score, the higher the level of function, with 100% representing no dysfunction. | Up to 54 months |
| Visual Analog Scale | Device performance and benefits as related to pain levels based on the Visual Analog Scale (range: 0 to 100; 0 = no pain; 100 = worst pain imaginable) | Up to 54 months |
| Patient satisfaction | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) | Up to 54 months |