At a glance
ClinicalIndex Comparison RecordN/ACompleted· 111 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study for Distal Radius Fracture and 2 related conditions. Completed, enrolled 111 participants across 1 site.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDistal Radius Fracture, Distal Ulna Fracture, Osteotomy
CountriesUnited Kingdom
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedDec 2020
Enrollment StartMar 2021
Primary CompletionOct 2021
Study CompletionNov 2022
TodayJul 2026
First PostedDec 4, 2020
Enrollment StartMar 12, 2021
Primary CompletionOct 3, 2021
Study CompletionNov 15, 2022
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.6 years ago