Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems

Study Overview
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Brief Summary
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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.

Detailed Description
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Common problems with existing clavicular plates are poor plate 'fit,' unbalance fixation, plate prominence, associated soft tissue irritation, subacromial pain, plate and/or fixation failure (due to unbalanced fixation) and high reoperation rate (for plate removal) [1-3]. The newly developed DePuy Synthes (DPS) variable angle locking compression plate (VA-LCP®) Clavicle 2.7 System was designed to address these problems. The system consists of lateral, shaft and medial plates and hook plates of different sizes to cover a wide variation in clavicular morphology and diverse fracture, fracture-dislocation and dislocation indications. The objective is to describe the short and long-term clinical performance and safety of both systems, as well as the functional outcomes of this patient population. Outcomes will be collected at baseline, 2 weeks, 6 weeks, 3 months, 6 months 1, and 2 years after surgery. In addition, the surgeons' experience and utility of the devices will be surveyed. For the short term evaluation, an interim analysis will be done as soon as 30 patients in each group have completed 6 months of follow-up (FU). The final evaluation of long-term outcomes will be done after 2 years of FU. All treatments and follow-up visits are according to standard of care.

Official Title
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Observational Case Series on the Clinical Performance of the DePuy Synthes Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 Systems

Conditions
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Clavicle, Acromioclavicular Joint, Fracture

Intervention / Treatment
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* Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years Unilateral clavicel injury and primary surgical treatment within 21 days from injury with a DPS VA-LCP® Clavicle Plate according to manufacturer's instruction use: VA-LCP® Clavicle Plates 2.7: Fixation of clavicle bone fragments VA-LCP® Clavicle Hook Plates 2.7: Fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint VA-LCP Clavicle Button Hook Plates 2.7: Fixation of acromioclavicular joint dislocations Expected ability to attend postoperative FU visits Patient informed and consent obtained according to the IRB/EC defined and approved procedures Exclusion Criteria: Stable clavicle fractures Systemic infection or infection localized to the site of the proposed implantation Concomitant nerve or vessel injury Polytrauma (Injury Severity Score ≥ 16) BMI ≥40 Uncontrolled severe systemic disease or terminal illness Intraoperative decision to use other implant

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System<br>Any patient undergoing surgical treatment for the fixation of clavicle bone fragments and acromioclavicular joint dislocations using the DPS VA-LCP® Clavicle Plate 2.7 System or DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 . | Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System<br>* The DPS VA-LCP® Clavicle Plate 2.7 System is indicated for the fixation of clavicle bone fragments. The system consists of three plate types: lateral, shaft, and medial, each available in different sizes and materials (titanium alloy and stainless steel). Each plate is available in left and right. The DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 System is indicated or the fixation of lateral clavicle fractures and AC joint dislocations. The Clavicle Hook Plate system consists of three plate types: long, short and button plates.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety aspects | Adverse events (AE) related or possibly related to the investigational device (ADE) or the procedure | 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 | The outcome measures for clinical performance are a subcategory of safety-related parameters (e.g. incidence of complaints related to plate prominence or discomfort, fracture union rate, rate of stable AC joint healing) | Through study completion, an average of 1 year | 
| Utility in terms of surgeons' experience | Surgeons satisfaction with the use and handling of the devices is evaluated in a questionnaire using 5-point Likert scale questions. These include: Surgical time (skin to skin) required for fracture reduction and fixation Much less time than with other implants Slightly less time than with other implants No difference with other implants More time than with other implants Much more time than with other implants Surgeon's impression of the fitting of the device Implant fitted well, no contouring required Implant fitted well, minimal contouring required Implant fitted well laterally but required contouring medially Implant fitted well medially but required contouring laterally Implant required contouring medially and laterally | Assessed immediately after the surgery | 
| Surgical time | Surgical time in minutes | Assessed immediately after surgeries | 
| Fluoroscopy time | Fluoroscopy time in minutes | Assessed immediately after surgeries | 
| The Disabilities of the Arm Shoulder and Hand short form (QuickDASH) | The Disabilities of the Arm Shoulder and Hand short form (QuickDASH) questionnaire was designed as an occupational health and disability questionnaire. It includes 30 questions that have to be rated from 1 (no difficulty) to 5 (unable) where lower values indicate less disability and higher values indicate more disability. | 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) | The PROMIS Physical Function Upper Extremity Short Form 7a v2.0 (2018) consists of 7 questions aimed to evaluate activities that require use of the upper extremity including shoulder, arm, and hand activities. Questions can be rated from 1 without any difficulties to 5 unable to do where lower values indicate less disability and higher values indicate more disability. | 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 |