PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System
- Conditions
- Proximal Humeral FractureProximal Tibia FracturesDiaphyseal Fracture
- Registration Number
- NCT05215613
- Lead Sponsor
- Zimmer Biomet
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Performance: Fracture Healing 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. Performance will be assessed by analyzing fracture healing radiographically or clinically. Timepoints at which the data will be collected will be summarized through means.
- Secondary Outcome Measures
Name Time Method Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) 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. Safety will be assessed by recording and analyzing the incidence and frequency of complications and adverse events. Timepoints at which the data will be collected will be summarized through means.
Tegner Lysholm Knee Score (Proximal Tibia) Final follow-up visit at minimum 1 year postoperative. Assessment of patient-reported outcome measures (PROMs):The Lysholm Knee Scoring Scale is an outcome measure addressing the following 8 symptoms; instability (25 points), pain (25 points), locking (15 points), swelling (10 points), stair climbing (10 points), limp (5 points), support (5 points), and squatting (5 points). Each of the 8 metrics uses different scoring systems. The total score is the sum of the 8 individual responses. Scores range from 0 (worse disability) to 100 (less disability).
Oxford Shoulder Score (OSS) (Proximal Humerus) Final follow-up visit at minimum 1 year postoperative. Assessment of patient-reported outcome measures (PROMs): The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TSA. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 5 (worst outcome) to 0 (best outcome) and the sum of all 12 items is reported with a maximum of 60, representing the worst score possible.
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis) Final follow-up visit at minimum 1 year postoperative. Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D) is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS), the highest score is 100 and the lowest score is 0. The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573.
Trial Locations
- Locations (1)
SC Clinica Ortopedica e Traumatologica II IRCCS Istituto Ortopedico Rizzoli
🇮🇹Bologna, Italy