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: Distal Radius Fracture, Distal Ulna Fracture, Osteotomy
Sponsor: Zimmer Biomet

 
Revision 1 
 
Clinical Investigation Plan  
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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 
 
Revision 1 
08/05/2019 
NCT04653051 
 
 
 
 
 
 
 
STUDY SPONSOR  
 
 
Zimmer GmbH 
Sulzerallee 8 
P.O. Box 
CH-8404 Winterthur 
Switzerland 
Tel. +41 (0)58 854 80 00 
 
 
 

 
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Clinical Investigation Plan  
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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 
CIP ID: MDRG2017-89MS-14T 
Sponsor: Zimmer GmbH  
Manufacturer: Biomet Trauma, Warsaw, Indiana, USA 
Objectives: The objective of this retrospective PMCF study is to collect data confirming 
safety, performance and clinical benefits of the DVR Plating System (implant 
and instrumentation) 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. 
Population: Consecutive series of subjects implanted with one of the DVR Plating System 
according to the approved/cleared indications. Inclusion/exclusion criteria are 
in accordance to the indications and contraindications in the IFU. The devices 
included in the study will be the ones used in accordance with their IFU and/or 
Zimmer Biomet’s approved labeling. 
Inclusion/Exclusion 
Criteria 
Inclusion Criteria: 
All subjects must have been implanted with one of the DVR Plates 
according to the approved indications. 
 

 
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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 
Study Design: Single-center, Retrospective, Consecutive series 
Clinical Phase: Post-market 
Number of 
Subjects: 
115 cases (in 111 patients) implanted with the DVR Plating System: 
 
Length of Study: 12 months overall: 
- 
Ethics Committee approval, patients’ identification, consent and 
enrollment into the study 
- 
Collection of baseline information available in medical notes from the 
pre-OP condition to the immediate post-OP and last consultation visit 
- 
Conduct follow-up phone calls, data collection, analysis, and final report 

 
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Clinical Investigation Plan  
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Study Device: DVR Plates: 
DVR Crosslock Plates (and respective instrumentation)  
  
 
 
 
 

 
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Clinical Investigation Plan  
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 DVR Wrist Plates (and respective instrumentation) 
 
DVR Volar Rim Plates (and respective instrumentation) 
 
  
Score: Patient-Rated Wrist Evaluation Score (PRWE) 
Documentation: Paper / electronic 
Statistical Analysis: Data collected in the study will be summarized descriptively. Continuous 
data (e.g. age) will be summarized through means, medians, standard 
deviation, minimum, maximum and 95% confidence intervals (CIs). 

 
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Categorical data (e.g. gender) will be summarized using counts, 
percentages and 95% confidence limits. Summaries of fracture healing and 
osteotomy rates, implant related revision rates and complication data will be 
presented as frequencies and percentages. 
 
 
References 
1. Clinical Investigation of medical devices for human subjects – Good Clinical practice. ISO 
14155:2011.