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.
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.
Study Type
OBSERVATIONAL
Enrollment
111
Southampton General Hospital
Southampton, United Kingdom
Fracture Healing Based on Clinical Measures and X-rays
Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)
Time frame: Mean time of 3.8 years after the surgery
Product Safety Based on Complications
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). .
Time frame: Mean time of 3.8 years after surgery
Patient's Outcomes Were Also Assessed
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.
Time frame: Mean time of 3.8 years after surgery
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