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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05215613
• Other study ID #: MDRG2017-89MS-158T
• Status: Completed
• Start date: March 15, 2023
• Est. completion date: March 27, 2024

Study information

• Verified date: April 2024
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 27, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Humeral Fractures
• Proximal Humeral Fracture
• Shoulder Fractures
• Tibial Fractures

Locations

Country	Name	City	State
Italy	SC Clinica Ortopedica e Traumatologica II IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.