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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Fracture; Clavicle; Acromioclavicular Joint
• Intervention / Treatment: Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 76

Contacts and Locations

• Study Contact: Name: Maria Clara Medina Giner; Phone Number: +41 79 545 61 20; Email: maria.medinaginer@aofoundation.org
• Study Contact Backup: Name: Marco Minoia, PhD; Phone Number: +41 79 612 09 67; Email: marco.minoia@aofoundation.org

Study Locations

• Austria
  • Vienna, Austria, 1160
    • Recruiting
    • Klinik Ottakring
    • Contact: Franz Kralinger, Prof Dr; Email: ordination@kralinger.at
    • Contact: Richard Arnhold, Dr; Email: richardarnhold@gmail.com
• Germany
  • Freiburg im Breisgau, Germany, 79106
    • Recruiting
    • Universitatsklinikum Freiburg
    • Contact: Martin Jäger, MD; Email: martin.jaeger@uniklinik-freiburg.de
    • Contact: Johannes Bausch, Dr; Email: johannes.bausch@uniklinik-freiburg.de
  • Münster, Germany, 48149
    • Recruiting
    • Universitatsklinikum Munster
    • Contact: Julia Sußiek, Dr; Email: julia.sussiek2@ukmuenster.de
• Switzerland
  • Lucerne, Switzerland, 6000
    • Recruiting
    • Luzerner Kantonsspital
    • Contact: Frank Beeres, Dr; Email: frank.beeres@luks.ch
• United States
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
      • Recruiting
      • Corewell Health
      • Contact: Todd Conlan; Phone Number: 330-265-3097; Email: todd.conlan@corewellhealth.org
      • Principal Investigator: Todd Conlan
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist
      • Contact: Eben Carroll, Prof Dr; Email: ecaroll@wakehealth.edu
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Recruiting
      • Prisma Health Richland Hospital
      • Contact: Daniel Cunningham, MD; Email: Daniel.cunningham2@prismahealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System; 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; 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.

What is the study measuring?

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 fixationMuch less time than with other implantsSlightly less time than with other implantsNo difference with other implantsMore time than with other implantsMuch more time than with other implants; Surgeon's impression of the fitting of the deviceImplant fitted well, no contouring requiredImplant fitted well, minimal contouring requiredImplant fitted well laterally but required contouring mediallyImplant fitted well medially but required contouring laterallyImplant 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient characteristics	Demographics	Baseline
Patient characteristics	Height in centimeters	Baseline
Patient characteristics	Weight in kilograms	Baseline
Patient characteristics	Body Mass Index (BMI) in kg/m^2	Baseline
Comorbidities	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.	Baseline
Injury details	Date of injury. Only the year of birth will be assessed.	Baseline
Injury details	Side injured (i.e. left/right)	Baseline
Fracture classification	- Clavicle fracture will be recorded using two classifications: AO/OTA Classification and Robinson Classification - AC joint dislocation: Rockwood classification	Baseline
Surgical details	Date of surgery	Intraoperative
Surgical time	Surgical time (i.e. defined as skin-to-skin time) in minutes	Intraoperative
Plate details	Clavicle Plate System; Type of plate and sizeLateralCS1CS2CS3ShaftCS1CS2CS3XLMedial; MaterialStainless steelTitanium alloy Clavicle Hook System; Type of plate and hook depthLong9 mm12 mm15 mmShort9 mm12 mm15 mmButton9 mm12 mm15 mm; MaterialStainless steelTitanium alloy	Intraoperative
Screw details	Screw details will be documented per fragment side (medial and lateral) as: Number of screws; Diameter; Typevariable angle lockingmetaphysealcortex	Intraoperative
Adjunctive fixations	Osseo cerclage suture; Direct ligament suture; Internal brace; Ligament augmentation for primary repair; Suture anchors; Muscular reattachment; Other	Intraoperative
Patient reported outcomes	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.	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
Radiographical outcomes - Screw density and distribution	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	Patients treated with clavicle plate: Intraoperative, 2 weeks; Patients treated with clavicle hook plate: Intraoperative, 2 weeks
Radiographical outcomes - Osteolysis	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	Patients treated with clavicle hook plate: Intraoperative until device removal (approximately 3months)
Radiographical outcomes - Bone union	Bone union is defined as the presence of bridging callus in three of four cortices on orthogonal views	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
Radiographical outcomes - Quality of reduction	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	Patients treated with clavicle plate: Immediately after surgery; Patients treated with clavicle hook plate: Immediately after surgery
Radiographical outcomes - Acromioclavicular and coracoclavicular	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.	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

Collaborators and Investigators

• Sponsor: AO Innovation Translation Center
• Investigators: Principal Investigator: Simon Lambert, University College London Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Estimated): August 29, 2025
• Last Update Submitted That Met QC Criteria: August 28, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: VA Clavicle

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No