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

Condition(s) studied

Investigational drug(s) / intervention(s)

DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System: 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Safety aspects — 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
  Adverse events (AE) related or possibly related to the investigational device (ADE) or the procedure
• Clinical performance — Through study completion, an average of 1 year
  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)
• Utility in terms of surgeons' experience — Assessed immediately after the surgery
  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 — Assessed immediately after surgeries
  Surgical time in minutes
• Fluoroscopy time — Assessed immediately after surgeries
  Fluoroscopy time in minutes
• The Disabilities of the Arm Shoulder and Hand short form (QuickDASH) — 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
  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.
• Patient-Reported Outcomes Measurement Information System (PROMIS) — 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
  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.

Trial sites (7)

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