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.
Study Type
OBSERVATIONAL
Enrollment
82
Subjects who have undergone a foot and/or ankle procedure involving the index device
Henry Ford Health Systems
Jackson, Michigan, United States
Incidence of secondary procedures
Safety will be assessed by recording the incidence of secondary procedures related to the index procedure
Time frame: Up to 9 months
Incidence of adverse events
Safety will be assessed by recording the incidence of adverse events
Time frame: Up to 9 months
Rate of Nonunion
Safety as related to the rate of nonunion of the area treated with the index device
Time frame: Up to 9 months
Rate of Maintenance of Correction
Safety as related to the rate of the maintenance of correction
Time frame: Up to 9 months
Rate of Index Device Failure
Safety as related to the rate of the failure of the index device
Time frame: 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.
Time frame: 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)
Time frame: Up to 54 months
Patient satisfaction
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Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
Time frame: Up to 54 months