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

Proximal Humeral Fracture Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05215613
Study type	Observational
Source	Zimmer Biomet
Contact
Status	Completed
Phase
Start date	March 15, 2023
Completion date	March 27, 2024

View Details

See also
Status	Clinical Trial	Phase
Not yet recruiting	`NCT06467006` - AI PREDICTION FOR PROXIMAL HUMERAL FRACTURES
Active, not recruiting	`NCT06444828` - Comparing Outcomes of Non-surgical Versus Surgical Treatment of Shoulder Fractures With Different Shoulder Replacements	N/A
Recruiting	`NCT04762667` - Individual Preoperative Planning for RSA	N/A
Active, not recruiting	`NCT03531463` - The Nordic DeltaCon Trial for Displaced Proximal Humeral Fractures in Elderly	N/A
Terminated	`NCT03711591` - Single Center Post Approval Proximal Humerus Fixation With the Conventus Cage PH™ Device
Completed	`NCT03339570` - Orthopaedic Treatment Proximal Humeral Fractures
Completed	`NCT03919422` - Paravertebral Block for Proximal Humeral Fracture Surgery	N/A
Completed	`NCT01984112` - Proximal Humerus Fractures: Randomized Study Between Locking Nails and Locking Plates for Neer 2 and 3 Parts	N/A
Completed	`NCT00863473` - Comminuted Proximal Humeral Fractures. A Randomised Study of Surgical Versus Conservative Treatment	Phase 2
Not yet recruiting	`NCT06416618` - Surgical Versus Non-surgical Treatment of Displaced Proximal Humerus Fracture in Adults Aged 50 to 65 Years	N/A
Recruiting	`NCT04543682` - A Clinical Trial Investigating Iloprost as Medication to Improve Bone Healing in Patients With Proximal Humeral Fracture	Phase 1/Phase 2
Recruiting	`NCT04748016` - 3D-printed Bone Models in Addition to CT Imaging for Intra-articular Fracture Repair	N/A
Completed	`NCT04786639` - Surgical Fixation and Non-Operative Management Outcomes in Proximal Humerus Fractures
Active, not recruiting	`NCT04623346` - Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic
Recruiting	`NCT05437822` - Tranexamic Acid in Proximal Humeral Fractures	Phase 4
Terminated	`NCT03567954` - The Accuracy of Ultrasound in Detecting Rotator Cuff Tears in Proximal Humerus Fracture Patients
Recruiting	`NCT03626038` - Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System	N/A
Not yet recruiting	`NCT05960435` - Proprioceptive Neuromuscular Facilitation Techniques in Proximal Humerus Fractures	N/A
Recruiting	`NCT03243409` - Perioperative Complications in Reversed Shoulder Arthroplasties	N/A
Completed	`NCT04622852` - Pegs for Osteofixation of Proximal Humeral Fractures

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.