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

Completed

Brief Summary: 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. Patients' outcomes will also be assessed.

Detailed Description: 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Fracture Healing Based on Clinical Measures and X-rays	Mean time of 3.8 years after the surgery	Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)

Secondary Outcome Measures

Name	Time	Method
Product Safety Based on Complications	Mean time of 3.8 years after surgery	Safety will be assessed by recording and analyzing the incidence and frequency of complications. The complications are classified per ISO 14155 Definitions: Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs). .
Patient's Outcomes Were Also Assessed	Mean time of 3.8 years after surgery	Patients were asked to complete a patient questionnaire (Patient-Rated Wrist Evaluation Score- PRWE)\* and a question on their wrist function\\ \* the PRWE is a self-administered, patient-specific questionnaire that consists of 15 items. It was designed to measure wrist pain and disability in activities of daily living, and consists of two subscales: pain and function. A score of 100 represents the worst functional score, whereas 0 represents no disability \\ Patient reported outcome: assessment of fractured wrist comparing to before injury on a scale from 0 to 10, 0 being worst imaginable, and 10 being as good as before the injury.