Evaluating the performance of new clavicle plates for fractures and dislocations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to gather evidence on the clinical performance and safety of the DePuy Synthes variable angle locking compression plate (VA-LCP) Clavicle 2.7 System. A minimum of 76 patients with clavicle fractures or acromioclavicular joint dislocations will be enrolled and followed for up to two years post-surgery. Outcomes will be assessed at multiple time points, including baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. The study will also evaluate the surgeons' experiences with the devices used.

Why it matters

Who can join: the full rules

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

Where it's running

• Corewell Health
  Grand Rapids, Michigan, United States Recruiting
• Atrium Health Wake Forest Baptist
  Winston-Salem, North Carolina, United States Recruiting
• Prisma Health Richland Hospital
  Columbia, South Carolina, United States Recruiting
• Klinik Ottakring
  Vienna, Austria Recruiting
• Universitätsklinikum Freiburg
  Freiburg im Breisgau, Germany Recruiting
• Universitätsklinikum Münster
  Münster, Germany Recruiting

Study contacts

• Principal investigator: Simon Lambert — University College London Hospitals
• Study coordinator: Marco Minoia, PhD
• Email: marco.minoia@aofoundation.org
• Phone: +41 79 612 09 67

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• See if a new tomosynthesis imaging tool helps diagnose MSK issues in ED and clinic

  This study tests whether the Nanox.ARC Digital Tomosynthesis system can add diagnostic value for adults with suspected MSK problems and potentially reduce the need for CT or MRI.

  Recruiting Nano-X Imaging · Kfar Saba · NCT07900412

• REMS testing for osteoporosis diagnosis and fracture risk in adults compared with DXA

  This study tests whether REMS can diagnose osteoporosis and predict fracture risk in adults who are being evaluated for bone health, using DXA as the standard reference.

  Recruiting at 2 sites BoneVue Diagnostics · Easton, Maryland and 1 other locations · NCT07876882

• See how well iFuse TORQ TNT works for pelvic fragility fractures

  This study tests the iFuse TORQ TNT implant in older adults with pelvic fragility fractures to see if real-world use leads to better outcomes.

  Recruiting at 3 sites SI-BONE, Inc. · Edina, Minnesota and 2 other locations · NCT07530497

• Buprenorphine for pain relief in older adults with broken bones in the ED

  This study tests whether buprenorphine can safely and effectively relieve pain in older adults with acute fractures, compared with hydromorphone.

  Recruiting Phase 1/2 Cooper Norcross Health · Camden, New Jersey · NCT07430345

• Rigid taping for acromioclavicular (AC) joint degeneration

  We will try rigid taping plus a standard exercise program to see if it reduces shoulder pain and improves motion and function in adults aged 18–65 with imaging-confirmed AC joint degeneration.

  Recruiting Hacettepe University · Ankara, Ankara · NCT07333417

• Cannabidiol for pain relief after traumatic fractures and to reduce opioid use

  We will test whether taking cannabidiol twice daily for one month can reduce pain and opioid use in adults 18–70 treated for recent long-bone fractures at Sacré-Coeur Hospital.

  Recruiting Phase 2 Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal · Montreal, Quebec · NCT06448923

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.