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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient characteristics | Demographics | Baseline |
| Patient characteristics | Height in centimeters | Baseline |
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:
Expected ability to attend postoperative FU visits
Patient informed and consent obtained according to the IRB/EC defined and approved procedures
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Simon Lambert | University College London Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corewell Health | Recruiting | Grand Rapids | Michigan | 49503 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41583835 | Derived | 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. |
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|
| 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 |
| 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
Clavicle Hook System
| Intraoperative |
| Screw details | Screw details will be documented per fragment side (medial and lateral) as:
| Intraoperative |
| Adjunctive fixations |
| 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:
| 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:
| 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 |
| Atrium Health Wake Forest Baptist | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
|
| Prisma Health Richland Hospital | Recruiting | Columbia | South Carolina | 29203 | United States |
|
| Klinik Ottakring | Recruiting | Vienna | 1160 | Austria |
|
| Universitätsklinikum Freiburg | Recruiting | Freiburg im Breisgau | 79106 | Germany |
|
| Universitätsklinikum Münster | Recruiting | Münster | 48149 | Germany |
|
| Luzerner Kantonsspital | Recruiting | Lucerne | 6000 | Switzerland |
|
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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