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

NCT04921865 | Recruiting

• 1 other identifier: VA Clavicle
• Study Type: observational
• Target: 76
• Locations: 4 countries
• Sites: 7

Brief 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.

Conditions

Clavicle; Acromioclavicular Joint; Fracture

Outcome Measures

Primary Outcomes (7)

• 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

Other Outcomes (19)

• Patient characteristics

  Baseline

• Patient characteristics

  Baseline

• Patient characteristics

  Baseline

Study Arms (1)

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AO Innovation Translation Center: lead

Study Sites (7)

Corewell Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

RECRUITING

Prisma Health Richland Hospital

Columbia, South Carolina, 29203, United States

RECRUITING

Klinik Ottakring

Vienna, 1160, Austria

RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsklinikum Münster

Münster, 48149, Germany

RECRUITING

Luzerner Kantonsspital

Lucerne, 6000, Switzerland

RECRUITING

Related Publications (1)

• Jaeger M, Sussiek J, Beeres F, Carroll E, Conlan T, Cunningham D, Arnhold R, Lambert S. Observational case series on the clinical performance of the Variable Angle Clavicle Plate and Clavicle Hook Plate 2.7 systems: a study protocol. Front Surg. 2026 Jan 8;12:1694295. doi: 10.3389/fsurg.2025.1694295. eCollection 2025.

  PMID: 41583835 DERIVED

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Simon Lambert

  University College London Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marco Minoia, PhD

CONTACT

+41 79 612 09 67; marco.minoia@aofoundation.org

Maria Clara Medina Giner

CONTACT

+41 79 545 61 20; maria.medinaginer@aofoundation.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: June 10, 2021
• Study Start: July 10, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

AU (1); US (3); DE (2); CH (1)