Clinical trial NCT05215613: PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
Official title: PMCF 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proximal Humeral Fracture
Proximal Tibia Fractures
Diaphyseal Fracture
Keywords: Medical device
Performance
Safety
Clinical benefits
Diaphysis
Proximal humerus
Proximal Tibia
Fracture
Post Market Clinical Follow Up Study
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2022-01-31
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Performance: Fracture Healing
timeFrame: At last consultation visit either at minimum 6 months post-operative by radiographic assessment or, if no x-rays available, by clinical assessment at the follow-up phone call at minimum 1 year postoperative.
Secondary outcomes:
measure: Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)
timeFrame: 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.
measure: Tegner Lysholm Knee Score (Proximal Tibia)
timeFrame: Final follow-up visit at minimum 1 year postoperative.
measure: Oxford Shoulder Score (OSS) (Proximal Humerus)
timeFrame: Final follow-up visit at minimum 1 year postoperative.
measure: EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis)
timeFrame: Final follow-up visit at minimum 1 year postoperative.
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: SC Clinica Ortopedica e Traumatologica II IRCCS Istituto Ortopedico Rizzoli
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: