The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU).
The objective of this retrospective enrollment/prospective follow up study is to collect data confirming safety, performance, and clinical benefits of the Biomet Cannulated Bone Screw System (Implants and Instrumentation) when used according to the approved Indications for Use (IFU). Safety will be established by recording the incidence and frequency of complications and adverse events. Relationship of the events to either implant or instrumentation should be specified. Performance and clinical benefits will be assessed by analyzing fracture healing/fusion and the overall pain and functional performance of subjects who received the Biomet Cannulated Bone Screws by recording survey questions. Zimmer Biomet defines the expected performance rate for Cannulated Screws for long and small bone fractures to be a union rate of at least 81% at 8-12 months.
Study Type
OBSERVATIONAL
Enrollment
51
Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw.
Zimmer Biomet
Warsaw, Indiana, United States
Orthopedic Foot and Ankle Center
Worthington, Ohio, United States
Associated Foot & Ankle Centers of Northern Virginia
Lake Ridge, Virginia, United States
Device Safety Assessed Through the Incidence and Frequency of Revisions, Complications, and Adverse Events
Assessment of safety by recording and analyzing the incidence and frequency of revisions, complications, and adverse events.
Time frame: Out to12+ months
Device Performance and Clinical Benefits Assessed by a Patient Questionnaire Case Report Form
Performance and clinical benefits demonstrated by the assessment of survey questions.
Time frame: Out to 12+ months
Device Performance and Clinical Benefits Assessed by a Follow-Up Analysis Case Report Form
Performance and clinical benefits demonstrated by the assessment of fracture healing/fusion and survey questions.
Time frame: Out to 12+ months
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