DVR Plating System Post-market Clinical Follow-up Study Version 01
Research type
Research Study
Full title
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
IRAS ID
271214
Contact name
Alistair/AP Phillips
Contact email
Sponsor organisation
Zimmer Biomet
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Distal Volar Radius (DVR®) Plating System (Implant and Instrumentation)
Hand and wrist injuries are common among athletes. The treatment of distal radius fractures experienced a revolution in hand and wrist trauma when the DVR device was released in 2000. Since then, the brand continues to evolve helping restore motion of the hand and wrist. The objective of this study is to collect data confirming safety, performance and clinical benefits of the DVR Plating System when used for the treatment of wrist fractures. The primary objective is the assessment of performance by analyzing fracture healing. The secondary objectives are the assessment of safety by recording and analyzing the incidence and frequency of complications and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. Patients’ outcomes will also be assessed.
Summary of Results
115 consecutive cases (in 111 patients) were enrolled at 1 site, in the Southampton General Hospital, UK. Fracture/osteotomy healing was assessed radiologically at the last follow-up visit at the hospital and/or clinically during a follow-up phone call. Additionally, performance and clinical benefits were assessed by recording and analyzing potential benefits through the evaluation of the patient-rated wrist evaluation (PRWE) score and by evaluating the general wrist function compared to before the injury. Finally, product safety was assessed by recording and analyzing the incidence and frequency of complications and adverse events.
Fracture/osteotomy healing was assessed in 105 cases radiographically at a mean time of 0.2 years (0.0 to 0.7 years), with 103 cases (103/105, 98.1%) showing normal healing and 2 cases showing fracture not properly healed (2/104, 1.9%), and clinically (pain at fracture site) for 114 cases and 114 cases (114/114, 100.0%) showed successful bone union at a mean follow-up time of 3.8 years (2.2 - 4.7 years). The mean PRWE score collected at a mean follow-up time of 3.8 years (2.2 - 4.7 years) post-operatively, was 12.8 (N=114). In addition, patients assessed their wrist function compared to before the injury on a scale from 0 to 10 (0 being worst imaginable, 10 being as good as before the injury), resulting in a mean score of 8.0 (N=113). In total, 92 complications were reported in 62 cases. 77 were classified as adverse events (AE), 4 as serious adverse events (SAE), 11 as adverse device effects (ADE), 0 as serious adverse device effects (SADE) and 0 as device deficiencies (DD). 19 of these complications have been resolved, and 58 were tolerated without re-operation and 6 of these complications are pending at the time of the last follow-up phone call. 9 complications required a re-operation.REC name
London - Westminster Research Ethics Committee
REC reference
20/LO/0261
Date of REC Opinion
28 May 2020
REC opinion
Further Information Favourable Opinion