PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System

Study Overview
=================
Brief Summary
-----------------
The study is a monocentric, retro- and prospective, 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 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.

Detailed Description
-----------------
The Zimmer® Plates and Screws System consists of temporary internal fixation devices comprised of plates and screws that provide management of fractures through interfragmentary compression and bone plating. In this study, the focus is on the Zimmer® Plates and Screws System used to stabilize diaphyseal, proximal humerus and proximal tibia fractures. One site will be involved in this study. The aim is to include a maximum of 112 consecutive series cases who received the Zimmer® Plates and Screws System at the Istituto Ortopedico Rizzoli (Bologna, Italy) between 2008 and 2018. All potential study subjects will be required to participate in the Informed Consent process. Baseline data from the preoperative, intraoperative, immediate post-operative and last consultation visit at minimum 6 months post-operative will be available in medical notes and collected retrospectively. During a follow up phone call the subject will be asked to complete questionnaires and a clinical assessment of the fracture healing. In addition, any complications since the last consultation visit at the clinic and information about the treatment of the complications will also be collected over the phone.

Official 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

Conditions
-----------------
Proximal Humeral Fracture, Proximal Tibia Fractures, Diaphyseal Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having received one of the plates belonging to the Zimmer® Plates and Screws System, designed for temporary internal fixation to stabilize fractures during the normal healing process. In this study we will collect data specifically on Zimmer® Plates and Screws System plates belonging to the Diaphysis, Proximal Humerus and Proximal Tibia groups. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients implanted with the Zimmer® Plates and Screws System<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance: Fracture healing | Performance will be assessed by analyzing fracture healing radiographically or clinically. | At last consultation visit at minimum 6 months post-operative and at follow-up phone call at minimum 1 year postoperative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product safety | Safety will be assessed by recording and analyzing the incidence and frequency of complications and adverse events. | At operative evaluation, immediate post-operative evaluation, last consultation visit at minimum 6 months post-operative and at the follow-up phone call at minimum 1 year postoperative. | 
| Tegner Lysholm Knee Score | Assessment of patient-reported outcome measures (PROMs): The Tegner Lysholm Knee Score consists of 8 subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). This score is used for the Proximal Tibia Group in this study. | Final follow-up visit at minimum 1 year postoperative. | 
| Oxford Shoulder Score (OSS) | Assessment of patient-reported outcome measures (PROMs): The Oxford Shoulder Score (OSS) consists of 12 questions specifically designed and developed for assessing outcomes of shoulder surgery. The score will be on a scale from 0 (worst) to 48 (best). This score is used for the Proximal Humerus Group in this study. | Final follow-up visit at minimum 1 year postoperative. | 
| EuroQol five-dimensional Health Questionnaire (EQ-5D-5L) | Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D-5L) is a generic instrument. The EQ-5D-5L is scored on a 0 to 100 mm scale. 0 mm represents the worst... and 100 mm represents the best health you can imagine. This Questionnaire is used for the Diaphysis Group in this study. | Final follow-up visit at minimum 1 year postoperative. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Medical device, Performance, Safety, Clinical benefits, Diaphysis, Proximal humerus, Proximal Tibia, Fracture, Post Market Clinical Follow Up Study