An observational study in Clavicle, Acromioclavicular Joint and Fracture, sponsored by AO Innovation Translation Center. Recruiting at 7 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by AO Innovation Translation Center · Observational
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.
723 studies on the registry are indexed under Fractures, Bone; 114 are open to participants now.
This study's planned enrollment of 76 is below the median of 130 across 239 observational studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →AO Innovation Translation Center is the lead sponsor of 32 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Safety aspects
Adverse events (AE) related or possibly related to the investigational device (ADE) or the procedure
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
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)
Time frame: 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
Time frame: Assessed immediately after the surgery
Surgical time
Surgical time in minutes
Time frame: Assessed immediately after surgeries
Fluoroscopy time
Fluoroscopy time in minutes
Time frame: 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.
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)
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.
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
Patient characteristics
Demographics
Time frame: Baseline
Patient characteristics
Height in centimeters
Time frame: Baseline
Patient characteristics
Weight in kilograms
Time frame: Baseline
Patient characteristics
Body Mass Index (BMI) in kg/m\^2
Time frame: 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.
Time frame: Baseline
Injury details
Date of injury. Only the year of birth will be assessed.
Time frame: Baseline
Injury details
Side injured (i.e. left/right)
Time frame: Baseline
Fracture classification
\- Clavicle fracture will be recorded using two classifications: AO/OTA Classification and Robinson Classification \- AC joint dislocation: Rockwood classification
Time frame: Baseline
Surgical details
Date of surgery
Time frame: Intraoperative
Surgical time
Surgical time (i.e. defined as skin-to-skin time) in minutes
Time frame: Intraoperative
Plate details
Clavicle Plate System * Type of plate and size * Lateral * CS1 * CS2 * CS3 * Shaft * CS1 * CS2 * CS3 * XL * Medial * Material * Stainless steel * Titanium alloy Clavicle Hook System * Type of plate and hook depth * Long * 9 mm * 12 mm * 15 mm * Short * 9 mm * 12 mm * 15 mm * Button * 9 mm * 12 mm * 15 mm * Material * Stainless steel * Titanium alloy
Time frame: Intraoperative
Screw details
Screw details will be documented per fragment side (medial and lateral) as: * Number of screws * Diameter * Type * variable angle locking * metaphyseal * cortex
Time frame: Intraoperative
Adjunctive fixations
* Osseo cerclage suture * Direct ligament suture * Internal brace * Ligament augmentation for primary repair * Suture anchors * Muscular reattachment * Other
Time frame: 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.
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
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
Time frame: 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: * Not assessable * Partial: any lucency zone around the hook * Tip: lucency limited to the tip of the hook * Complete: lucency around all zones of the hook
Time frame: 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
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
Radiographical outcomes - Quality of reduction
In cases of fixation failure, quality of reduction will be assessed in the immediate postoperative radiographs and documented as: * Accurate reduction of simple fracture * Accurate alignment of complex fracture * Inaccurate reduction of simple fracture * Inaccurate alignment of complex fracture
Time frame: 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.
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
AO Innovation Translation Center