N/A
Completed N=56
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
proximal humeral fracture · Proximal Tibia Fractures · Diaphyseal Fracture
Source: ClinicalTrials.gov NCT05215613 ↗
Enrolled (actual)
56
Serious AEs
12.5%
Results posted
Feb 2025
Primary outcomePrimary: Performance: Fracture Healing — 29; 26; 2; 0 Fractures
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Performance: Fracture Healing |
29; 26; 2; 0 | — |
| SECONDARY Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) |
0; 3; 0; 3; 0; 0 | — |
| SECONDARY Tegner Lysholm Knee Score (Proximal Tibia) |
87.4 | — |
| SECONDARY Oxford Shoulder Score (OSS) (Proximal Humerus) |
— | — |
| SECONDARY EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis) |
0.70; 80.7 | — |
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
Data sourced from ClinicalTrials.gov (NCT05215613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.