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Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
This is an ambispective, multi-surgeon, single site, consecutive case series taking place in the United States. Once a subject is identified and informed consent is obtained from that subject, retrospective data will be collected from the subject's electronic medical record (EMR), and prospective data will be collected from subject-provided PROM's. A minimum of 16 and maximum of 23 subjects will participate in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: Grappler Interference Screw System | Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grappler Interference Screw System | Device | Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Device performance and benefits as related to Foot and Ankle Mobility Measure | Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction. | 6 months post-operative |
| Device performance and benefits as related to pain levels based on the 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)of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction. | 6 months post-operative |
| Device performance and benefits as related to pain levels based on Patient satisfaction | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) | 6 months post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Safety will be assessed by recording the incidence of secondary procedures related to the index device | Safety will be assessed by recording the incidence of secondary procedures related to the index device | 6 months post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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The investigational population will include a minimum of 23 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 |
|---|---|---|---|---|---|---|
| Orthopedic Foot and Ankle | Worthington | Ohio | 43085 | United States |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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