Ankle Injuries, Foot Injury
Conditions
Brief summary
Post-market clinical follow-up study on the Monster Screw System
Detailed description
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.
Interventions
DEVICEMonster Screw System
Subjects who have undergone a foot and/or ankle procedure involving the index device
Sponsors
Paragon 28
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators. * The subject has adequate radiographic and medical records For the Prospective Data Collection: \- The subject is willing to provide written informed consent
Exclusion criteria
-None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of secondary procedures | Up to 9 months | Safety will be assessed by recording the incidence of secondary procedures related to the index procedure |
| Incidence of adverse events | Up to 9 months | Safety will be assessed by recording the incidence of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Index Device Failure | Up to 9 months | Safety as related to the rate of the failure of the index device |
| Foot and Ankle Mobility Measure | Up to 54 months | 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. |
| Rate of Nonunion | Up to 9 months | Safety as related to the rate of nonunion of the area treated with the index device |
| Patient satisfaction | Up to 54 months | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) |
| Visual Analog Scale | Up to 54 months | 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) |
| Rate of Maintenance of Correction | Up to 9 months | Safety as related to the rate of the maintenance of correction |
Countries
United States
Outcome results
None listed