Health TrialsbyHealthPanel

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

ConditionsClavicleAcromioclavicular JointFracture
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAO Innovation Translation Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age >= 18 years

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

Disqualifiers

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)

Trial population

Any patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or the DPS VA-LCP® Clavicle Hook Plate 2.7 System for clavicular fracture or dislocations of the acromioclavicular joint

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System

    Device

    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.

Treatment groups

76 Participants
are divided into 1 treatment group
Group A: Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System1 intervention

Trial outcomes

Primary outcomes

1

Safety aspects

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

Time frame
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
2

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)

Time frame
Through study completion, an average of 1 year
3

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

Time frame
Assessed immediately after the surgery
4

Surgical time

Surgical time in minutes

Time frame
Assessed immediately after surgeries

Secondary outcomes

Other outcomes

1

Patient characteristics

Demographics

Time frame
Baseline
2

Patient characteristics

Height in centimeters

Time frame
Baseline
3

Patient characteristics

Weight in kilograms

Time frame
Baseline
4

Patient characteristics

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

Time frame
Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AO Innovation Translation Center

Lead sponsor

Source ClinicalTrials.gov
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