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

Adverse events (AE) related or possibly related to the investigational device (ADE) or the procedure

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)

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

Surgical time in minutes

Fluoroscopy time in minutes

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.

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.

Demographics

Height in centimeters

Weight in kilograms

Body Mass Index (BMI) in kg/m^2

Concomitant diseases will be assessed using the Charlson Comorbidity Index (CCI). This score assesses the comorbidity level by considering both the number and severity of pre-defined comorbid conditions. It provides a weighted score of a patient's comorbidities which can be used to predict mortality risk. The minimum possible score is 0 (no comorbidities) and maximum 29. The higher the score, the more likely the predicted outcome will result in mortality.

Date of injury. Only the year of birth will be assessed.

Side injured (i.e. left/right)

• Clavicle fracture will be recorded using two classifications: AO/OTA Classification and Robinson Classification

• AC joint dislocation: Rockwood classification

Date of surgery

Surgical time (i.e. defined as skin-to-skin time) in minutes

Clavicle Plate System

• Type of plate and size

• Lateral

• CS1
• CS2
• CS3
• Shaft

• CS1
• CS2
• CS3
• XL
• Medial
• Material

• Stainless steel
• Titanium alloy

Clavicle Hook System

• Type of plate and hook depth

• Long

• 9 mm
• 12 mm
• 15 mm
• Short

• 9 mm
• 12 mm
• 15 mm
• Button

• 9 mm
• 12 mm
• 15 mm
• Material

• Stainless steel
• Titanium alloy

Screw details will be documented per fragment side (medial and lateral) as:

• Number of screws
• Diameter
• Type

• variable angle locking
• metaphyseal
• cortex

• Osseo cerclage suture
• Direct ligament suture
• Internal brace
• Ligament augmentation for primary repair
• Suture anchors
• Muscular reattachment
• Other

Pain Numeric Rating Scale (NRS). Local pain will be assessed with the Numerical Rating Scale (NRS). The scale range goes from 0 (no pain) to 10 (worst imaginable pain). A higher value correlates with greater pain.

Will be assessed in intraoperative or the first postoperative image by analyzing the screw placement with regards to the fracture line, their distribution and type of screws used

Defined as the presence of a lucent line in the acromion around the tip and body hook of the clavicle hook plate. It will be documented as:

• Not assessable
• Partial: any lucency zone around the hook
• Tip: lucency limited to the tip of the hook
• Complete: lucency around all zones of the hook

Bone union is defined as the presence of bridging callus in three of four cortices on orthogonal views

In cases of fixation failure, quality of reduction will be assessed in the immediate postoperative radiographs and documented as:

• Accurate reduction of simple fracture
• Accurate alignment of complex fracture
• Inaccurate reduction of simple fracture
• Inaccurate alignment of complex fracture

Acromioclavicular and coracoclavicular distances (in mm) will be assessed using AC joint anteroposterior and Alexander views (if available). The AC distance is the distance between the most medial point on the acromion visible on an anteroposterior view of the AC joint and a point on a line drawn perpendicular to the plane of the dorsal aspect of the lateral or fifth of the clavicle.