The purpose of this study is to confirm the safety and effectiveness of the Internal Joint Stabilizer - Elbow.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Device designed for internal stabilization of the elbow
Massachusetts General Hospital
Boston, Massachusetts, United States
Broberg Morrey Functional Rating
To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation. The study is deemed a success if the at least 75% of patients receive a Broberg Morrey Functinoal Rating of Fair or better.
Time frame: Eight months (6 months post-explant)
Recurrent Dislocations
To confirm that the Internal Joint Stabilizer - Elbow (IJS-E) provides temporary stabilization of the elbow joint and allows functional recovery after trauma or chronic dislocation. The study is deemed a success if the at least 75% of patients do not have a recurrent dislocation while using the IJS-E or after removal of the IJS-E.
Time frame: 8 months (6 month post-explant)
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