Achilles Tendon Rupture, Ankle Injuries, Ankle Inversion Sprain, Ankle Sprains, Deltoid Ankle Sprain, Flexor Digitorum Longus on the Left, Flexor Digitorum Longus on the Right, Flexor Hallucis Longus on the Left, Flexor Hallucis Longus on the Right, Syndesmotic Injuries
Conditions
Brief summary
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
Detailed description
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.
Interventions
DEVICEGrappler Interference Screw System
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System
Sponsors
Paragon 28
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The subject underwent a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques * The subject signs a written informed consent form (ICF)
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device performance and benefits as related to Foot and Ankle Mobility Measure | 6 months post-operative | 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. |
| Device performance and benefits as related to pain levels based on the Visual Analog Scale | 6 months post-operative | 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. |
| Device performance and benefits as related to pain levels based on Patient satisfaction | 6 months post-operative | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety will be assessed by recording the incidence of secondary procedures related to the index device | 6 months post-operative | Safety will be assessed by recording the incidence of secondary procedures related to the index device |
Countries
United States
Outcome results
None listed