Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
- Conditions
- Acromioclavicular JointFractureClavicle
- Interventions
- Device: DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System
- Registration Number
- NCT04921865
- Lead Sponsor
- AO Innovation Translation Center
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
-
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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients treated with the DPS VA-LCP® Clavicle Plate 2.7 System or Hook Plate 2.7 System DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle 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 .
- Primary Outcome Measures
Name Time Method Fluoroscopy time Assessed immediately after surgeries Fluoroscopy time in minutes
Safety aspects 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 Adverse events (AE) related or possibly related to the investigational device (ADE) or the procedure
Utility in terms of surgeons' experience Assessed immediately after the surgery 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 laterallyThe Disabilities of the Arm Shoulder and Hand short form (QuickDASH) 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 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.
Patient-Reported Outcomes Measurement Information System (PROMIS) 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 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.
Clinical performance Through study completion, an average of 1 year 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)
Surgical time Assessed immediately after surgeries Surgical time in minutes
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
Prisma Health Richland Hospital
🇺🇸Columbia, South Carolina, United States
University Hospital
🇺🇸Cleveland, Ohio, United States
Klinik Ottakring
🇦🇹Wien, Austria
Metrohealth Medical Center
🇺🇸Cleveland, Ohio, United States
Luzerner Kantonsspital
🇨🇭Luzern, Switzerland
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitätsklinikum Münster
🇩🇪Münster, Germany