PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System

Study Overview
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Brief Summary
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The study is a single-center, retrospective, non-randomized, non-controlled and consecutive series post-market study. The purpose of this study is to confirm safety, performance and clinical benefits of the DVR Plates. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objective is the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events.

Detailed Description
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The DVR plating system in this study includes the DVR Crosslock Distal Radial Plate, the DVR Volar Rim Plate and the DVR Wrist Plates. One site will be involved in this study. The aim is to include a total of 112 consecutive series patients treated between 2014 and 2018. All potential study subjects will be required to participate in the Informed Consent Process. Baseline data from the preop, intraop, immediate post-op and last consultation visit will be available in medical notes and collected retrospectively. During a follow up phone call the patient will be asked to complete a patient questionnaire and a question on his/her wrist function. In addition, any complications since the last consultation visit at the clinic, information about and treatment of the complications will also be collected over the phone.

Official Title
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Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the DVR Plating System (Implant and Instrumentation) - A Retrospective Consecutive Series Study

Conditions
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Osteotomy, Distal Radius Fracture, Distal Ulna Fracture

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must have been implanted with one of the DVR Plates according to the approved indications. Exclusion Criteria: Off-label use. Cases where there is an active infection. Conditions which tend to retard healing such as, blood supply limitations, previous infections, etc. Insufficient quantity or quality of bone to permit stabilization of the fracture. Conditions that restrict the patient's ability or willingness to follow postoperative instructions during the healing process. Foreign body sensitivity - where material sensitivity is suspected, appropriate tests should be conducted and sensitivity ruled out prior to implantations. Cases where the implant(s) would cross open epiphyseal plates in skeletally immature patients. Cases with malignant primary or metastatic tumors which preclude adequate bone support or screw fixations, unless supplemental fixation or stabilization methods are utilized.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who received DVR Plating System<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture healing based on clinical measures and/or x-rays | Fracture healing will be evaluated by x-rays and/or clinical measures (no pain at fracture site) | From last consultation visit to follow-up phone call, 2-6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product safety based on complication and adverse events | Safety will be assessed by recording and analyzing the incidence and frequency of complications and adverse events | From operation to study completion, 2-6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical Device, Performance, Safety, Clinical Benefits, Post-Market Clinical Follow-Up Study