Observational Study of DPS VA-LCP® Clavicle Plate Systems for Clavicle Fractures
This study is looking at how well two types of surgical plates, the DPS VA-LCP® Clavicle Plate 2.7 System and the DPS VA-LCP® Clavicle Hook Plate 2.7 System, work for people with clavicle (collarbone) fractures or dislocations of the acromioclavicular (AC) joint. Researchers want to understand the safety and effectiveness of these plates over time. You might be able to join if you are at least 18 years old and have a clavicle injury that was surgically treated with one of these plates within 21 days of the injury. The study will track your progress for up to two years after surgery. The current status of this study is unclear.
- Study design
- This is an observational study aiming to enroll at least 76 participants. It is not specified if it is randomized or blinded.
- What's involved
- You will have follow-up visits at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. Surgeons' experiences with the devices will also be surveyed.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants treated with the clavicle plate will be followed for up to 24 months after surgery. Participants treated with the clavicle hook plate will be followed until device removal (approximately 3 months) and up to 12 months after device removal.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Case Series on the Clinical Performance of VA Clavicle and Clavicle Hook Plate 2.7 Systems
At a glance
Conditions
NCT04921865
Where you'd take part
This study runs at 7 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolinastudy coordinator listed
Recruiting
Corewell Health
Grand Rapids, Michiganstudy coordinator listed
Recruiting
Klinik Ottakring
Vienna, Austriastudy coordinator listed
Recruiting
Luzerner Kantonsspital
Lucerne, Switzerlandstudy coordinator listed
Recruiting
Prisma Health Richland Hospital
Columbia, South Carolinastudy coordinator listed
Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germanystudy coordinator listed
Recruiting
Universitätsklinikum Münster
Münster, Germanystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Simon Lambert · PRINCIPAL_INVESTIGATOR · University College London Hospitals
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Safety aspectsPatients 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
- Clinical performanceThrough 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)
- Utility in terms of surgeons' experienceAssessed 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 laterally
- Surgical timeAssessed immediately after surgeries
Surgical time in minutes
- Fluoroscopy timeAssessed immediately after surgeries
Fluoroscopy time in minutes
- The 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.