Recruiting

VA Clavicle

Sponsor:

AO Innovation Translation Center

Code:

NCT04921865

Conditions

Clavicle

Acromioclavicular Joint

Fracture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT04921865

Start date

Jul 10, 2024

Status verified date

Aug, 2025

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Jan 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

76 participants

Anticipated

Interventions and Outcome Measures

Arms

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 .

Interventions

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.

Primary outcome measure

  • Safety aspects [ 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 ]
  • Clinical performance [ Time Frame: Through study completion, an average of 1 year ]
  • Utility in terms of surgeons' experience [ Time Frame: Assessed immediately after the surgery ]
  • Surgical time [ Time Frame: Assessed immediately after surgeries ]
  • Fluoroscopy time [ Time Frame: Assessed immediately after surgeries ]
  • The Disabilities of the Arm Shoulder and Hand short form (QuickDASH) [ 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 ]
  • Patient-Reported Outcomes Measurement Information System (PROMIS) [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Marco Minoia, PhD

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

Maria Clara Medina Giner

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

Locations

Corewell Health

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Todd Conlan

330-265-3097todd.conlan@corewellhealth.org

Principal Investigator:

Todd Conlan

Atrium Health Wake Forest Baptist

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Eben Carroll, Prof Dr

ecaroll@wakehealth.edu

Prisma Health Richland Hospital

Recruiting

Columbia, South Carolina, United States, 29203

Contacts

Daniel Cunningham, MD

Daniel.cunningham2@prismahealth.org

More Information

Sponsor

AO Innovation Translation Center

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AO Innovation Translation Center on 2025-08-29.