PMCF Study to Provide Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System Applied for Diaphyseal, Proximal Humerus and Proximal Tibia Fractures (Implants and Instrumentation) - A Retro- and Prospective Consecutive Series Study
Conditions: Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture
Sponsor: Zimmer Biomet

Post-Market Clinical Follow-Up Study to Provide 
Safety, Performance and Clinical Benefits Data of 
the Zimmer® Plates and Screws System applied 
for Diaphyseal, Proximal Humerus and Proximal 
Tibia Fractures (Implants and Instrumentation) – A 
Retro- and Prospective Consecutive Series Study  
 
 
EMEA 
MDRG2017-89MS-158T 
V 1.2 
27-Sep-2024 
NCT05215613 
 
 
 
STUDY SPONSOR 
 
 
Zimmer GmbH 
Clinical Affairs 
Zählerweg 4 
CH-6300 Zug 
Switzerland 
+41 (0)58 854 80 00 
 
 

 
Study Synopsis 
Complete Protocol Title 
Post-Market Clinical Follow-Up Study to Provide Safety, 
Performance and Clinical Benefits Data of the Zimmer® 
Plates and Screws System applied for Diaphyseal, Proximal 
Humerus and Proximal Tibia Fractures (Implants and 
Instrumentation) – A Retro-and Prospective Consecutive 
Series Study 
Protocol Number 
MDRG2017-89MS-158T 
Short Protocol Title 
Zimmer Plates and Screws (ZPS) System Study 
Sponsor 
Zimmer GmbH, Zug, Switzerland 
Manufacturer 
Zimmer Inc. 
Study Device(s) 
ZPS System plates (implants and instrumentation) for which 
data is being collected within this study*:  
o Diaphysis group: 
 Compression Plate (2.0 and 2.7): 
 
 
 Compression Broad Plate: 
 
 
 Compression Narrow Plate: 
 
 
 One-Quarter Tubular Plate with Collar:  
 
 
 Cobra Head Plate: 
 
 
 Semi-Tubular Plate: 
 
 
 Straight Plate (1.5 and 2.0mm): 

 
 
 
o Proximal Humerus group: 
 T-Plate (4.5mm): 
 
 
 
 Cloverleaf-Plate: 
 
 
o Proximal Tibia group: 
 L-Buttress Plate: 
 
 
 T-Buttress Plate: 
 
 
 Spoon Plate: 
 
* Plates are grouped per anatomical region they are 
applied. 
Technical Documentation 
Reference Number 
414b, 402a, 401, 850  
Study Objectives/Endpoints 
The objective of this post-market clinical follow-up (PMCF) 
study is to collect data confirming safety, performance and 
clinical benefits of the Zimmer Plates and Screws System 
(implants and instrumentation) when used to stabilize 
diaphyseal, proximal humerus and proximal tibia 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. Subjects’ outcomes will also be assessed. 

Indications/Target Population 
Consecutive series of subjects implanted with plates and 
screws belonging to the ZPS System according to the 
indications for use. Please refer to the study device section 
of this synopsis for more details on the different plates used 
in this study. Inclusion/exclusion criteria are based on the 
indications and contraindications in the Instruction for Use 
(IFU). 
Inclusion/Exclusion Criteria 
The inclusion criteria are: 
Patients having received one of the plates belonging to the 
ZPS System, designed for temporary internal fixation to 
stabilize fractures during the normal healing process.  
In this study we will collect data specifically on ZPS plates 
belonging to the Diaphysis, Proximal Humerus and Proximal 
Tibia groups. 
 
The exclusion criteria are: 
• 
Off-label use 
• 
Patients under the age of 18 
• 
Prisoners 
• 
Severely comminuted fractures in which bone 
fragments are too small or numerous to adequately 
fix or maintain a reduced position. 
• 
Infection. 
• 
Metal sensitivity or intolerance. 
• 
Severe osteopenia and/or osteoporosis, or in the 
presence of marked or rapid bone absorption, 
metabolic bone disease, cancer, or any other 
tumor-like condition of the bone which may 
compromise fixation. 
• 
Sternal or spinal fractures. 
• 
Anatomical location in which the device would 
interfere with nerves, blood vessels, or other vital 
structures. 
• 
Patients with inadequate soft tissue coverage at the 
implant site. 
Study Design 
Single-Center, Retro- and prospective, Non-controlled, 
Non-randomized, Consecutive series of patients 
Clinical Phase 
Post-market 
Sample Size  
The goal is to collect data on a total of 112 consecutive cases 
operated with a plate belonging to one of the three ZPS 
System groups defined in this synopsis and distributed as 
following: 
• 
50 consecutive cases treated with a plate of the 
Diaphysis group.  

• 
52 consecutive cases treated with a plate of the 
Proximal Humerus group. 
• 
10 consecutive cases treated with a plate of the 
Proximal Tibia group. 
The cases should be equally distributed between the 
different plates of each group, if possible.  
Length of Study 
18 months overall: 
• 
Ethics Committee approval 
• 
Subject identification, consent and enrollment into 
the study 
• 
Collection of baseline and follow-up (FUP) 
information available in medical notes from the 
pre-operative condition to the immediate post-op 
and last consultation visit 
• 
Conduct FUP phone call 
• 
Conduct data collection, analyses, write an interim 
report as well as a final report or a manuscript. 
Materials and Methods 
Retrospective data will be collected from medical charts 
including baseline information from the preoperative, 
operative, immediate post-operative interval and last 
consultation visit. In addition, a prospective FUP call (min 1 
year post-op) will be performed. All data will be entered 
into an Excel database provided by the Sponsor. 
Data Collection 
Paper/Electronic 
Statistical Reporting 
Statistical analysis will be conducted by Zimmer Biomet or 
its designee. Data collected in the study will be 
summarized descriptively. Descriptive summaries will be 
the basis of study reports to participants, as well as to 
generate an overall summary of the clinical and 
radiological evaluation of the ZPS System groups described 
in this protocol. Continuous data (e.g. age) will be 
summarized through means, medians, standard deviation, 
minimum, maximum and 95% confidence intervals (CIs) 
over time periods of interest. Categorical data (e.g. 
gender) will be summarized using counts, percentages and 
95% confidence limits over time periods of interest. 
Summaries of fracture healing rate and complication data 
will be presented as frequencies and percentages. 
Subgroup summaries will be generated as needed either 
by strata within the study population (e.g. male vs. female) 
or by different cut-points (e.g. body mass index (BMI)) 
ranges.  
Scores/Performance Assessments 
Tegner and Lysholm (Proximal Tibia Group), Oxford 
Shoulder Score (Proximal Humerus Group), EQ-5D-5L 
(Diaphysis Group); Fracture Healing, Adverse Events 

Standards 
The PMCF is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of medical 
devices for human subjects - Good clinical practice [1]. 
• 
The Declaration of Helsinki (DoH) - Ethical principles 
for medical research involving human subjects [2]. 
• 
European Regulation (EU) 2017/745 [3]. 
• 
MDCG 2020-10/1 Safety reporting in clinical 
investigations for medical devices under the 
Regulation (EU) 2017/74 [4] 
Study Funding 
Funding for this clinical study is made available by Zimmer 
Biomet to support clinical data collection, IRB/EC review 
fees and other expenses associated with the conduct and 
execution of this study protocol as outlined in the fully 
executed Clinical Trial Agreement.