The purpose of this study is to gather early and mid- to long-term evidence to confirm the clinical performance, safety and use of the Clavicle Plate and Clavicle Hook Plate System. A minimum of 76 patients with clavicle fractures or dislocations of the AC joint surgically treated with any plate from the DPS VA-LCP Clavicle System will be enrolled in this observational post-market clinical investigation. Outcomes will be collected until up to 2 years after surgery.
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Safety aspects
Timeframe: Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal
Clinical performance
Timeframe: Through study completion, an average of 1 year
Utility in terms of surgeons' experience
Timeframe: Assessed immediately after the surgery
Surgical time
Timeframe: Assessed immediately after surgeries
Fluoroscopy time
Timeframe: Assessed immediately after surgeries
The Disabilities of the Arm Shoulder and Hand short form (QuickDASH)
Timeframe: Patients treated with clavicle plate: From baseline up to 24 months after surgery; Patients treated with clavicle hook plate: From baseline until device removal (approximately 3months) and up to 12 months after device removal
Patient-Reported Outcomes Measurement Information System (PROMIS)
Timeframe: Patients treated with clavicle plate: From baseline up to 24 months after device implantation surgery; Patients treated with clavicle hook plate: From baseline until device removal surgery (approximately 3months) and up to 12 months after device removal