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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Proximal Humeral Fracture; Proximal Tibia Fractures; Diaphyseal Fracture

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.

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

• Study Contact: Name: Andrea Singer; Phone Number: +41 79 318 06 55; Email: andrea.singer@zimmerbiomet.com

Study Locations

• Italy
  • Bologna, Italy, 40136
    • SC Clinica Ortopedica e Traumatologica II IRCCS Istituto Ortopedico Rizzoli
    • Contact: Zaffagnini Stefano, MD; Phone Number: +3951 8366 075; Email: stefano.zaffagnini@ior.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Consecutive series of cases implanted with plates and screws belonging to the Zimmer® Plates and Screws System according to Zimmer Biomet's Instruction for Use (IFU) and who meet the inclusion criteria and none of the exclusion criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients implanted with the Zimmer® Plates and Screws System

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.

Collaborators and Investigators

• Sponsor: Zimmer Biomet
• Investigators: Study Director: Hassan Achakri, Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2024

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Performance; Fracture; Medical device; Post Market Clinical Follow Up Study; Clinical benefits; Diaphysis; Proximal humerus; Proximal Tibia
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Shoulder Injuries; Arm Injuries; Fractures, Bone; Tibial Fractures; Humeral Fractures; Shoulder Fractures
• Other Study ID Numbers: MDRG2017-89MS-158T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No