Diaphyseal Fracture, Proximal Humeral Fracture, Proximal Tibia Fractures
Conditions
Keywords
Medical device, Performance, Safety, Clinical benefits, Diaphysis, Proximal humerus, Proximal Tibia, Fracture, Post Market Clinical Follow Up Study
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.
Interventions
None listed
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Participant flow
Pre-assignment details
1 patient's fracture was revised with the study device and was therefore enrolled twice as 2 separate cases in the study, as two study devices were used.
Participants by arm
| Arm | Count |
|---|---|
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate 30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis. | 30 |
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate 30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis. | 31 |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate 26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia. | 26 |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate 26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia. | 26 |
| Total | 113 |
Baseline characteristics
| Characteristic | Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Total | Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate |
|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 19.6 | 38.2 years STANDARD_DEVIATION 17.1 | 36.2 years STANDARD_DEVIATION 13.6 |
| AO/OTA Fracture Classification 12A1 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 12A2 | 3 Fractures | 3 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 12A3 | 3 Fractures | 3 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 12B2 | 2 Fractures | 2 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 12B3 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 2U2A2 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 32A1 | 4 Fractures | 4 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 32A2 | 3 Fractures | 3 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 32A3 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 32B2 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 32B3 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 32C2 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 41A | 0 Fractures | 2 Fractures | 2 Fractures |
| AO/OTA Fracture Classification 41A1.2 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41A2 | 0 Fractures | 2 Fractures | 2 Fractures |
| AO/OTA Fracture Classification 41A2.1 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41A2.2 | 0 Fractures | 7 Fractures | 7 Fractures |
| AO/OTA Fracture Classification 41A2.3 | 0 Fractures | 3 Fractures | 3 Fractures |
| AO/OTA Fracture Classification 41A3 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41A3.2 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41A3.3 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41B1.1 | 0 Fractures | 2 Fractures | 2 Fractures |
| AO/OTA Fracture Classification 41B1.2 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41B2.1 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41B3.1 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41C1 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 41C3.3 | 0 Fractures | 1 Fractures | 1 Fractures |
| AO/OTA Fracture Classification 42A1 | 2 Fractures | 2 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 42B1 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 42B3 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 4F2B1 | 2 Fractures | 2 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 4F2B2 | 1 Fractures | 1 Fractures | 0 Fractures |
| AO/OTA Fracture Classification 87A2 | 2 Fractures | 2 Fractures | 0 Fractures |
| Concomitant Diseases Cardiac / Respiratory Disease and Hypertension | 2 Fractures | 3 Fractures | 1 Fractures |
| Concomitant Diseases Cardiac / Respiratory Disease, Hypertension and Hypercholesterolemia | 1 Fractures | 1 Fractures | 0 Fractures |
| Concomitant Diseases Cardiac / Respiratory Disease, Hypertension, Hypercholesterolemia and Diabetes | 1 Fractures | 1 Fractures | 0 Fractures |
| Concomitant Diseases Congenital Hip Dysplasia | 0 Fractures | 2 Fractures | 2 Fractures |
| Concomitant Diseases Diabetes and Hypercholesterolemia | 1 Fractures | 1 Fractures | 0 Fractures |
| Concomitant Diseases Hypothyroidism | 0 Fractures | 1 Fractures | 1 Fractures |
| Concomitant Diseases None | 25 Fractures | 42 Fractures | 17 Fractures |
| Concomitant Diseases Osteogenesis Imperfecta | 0 Fractures | 1 Fractures | 1 Fractures |
| Concomitant Diseases Previous Open Fracture and Internal Fixation Right Femur and Patella 1 year earlier | 0 Fractures | 1 Fractures | 1 Fractures |
| Concomitant Diseases Prothrombin Gene Mutation | 0 Fractures | 1 Fractures | 1 Fractures |
| Concomitant Diseases Vascular Disease and Hypertension | 1 Fractures | 2 Fractures | 1 Fractures |
| Concomitant Diseases Vascular Disease and Venous Insufficiency Right Lower Limb | 0 Fractures | 1 Fractures | 1 Fractures |
| Confounding fractures for bone union None | 22 Fractures | 43 Fractures | 21 Fractures |
| Confounding fractures for bone union Obesity | 2 Fractures | 2 Fractures | 0 Fractures |
| Confounding fractures for bone union Obesity and Leri-Weill Dischondrosteosis | 0 Fractures | 1 Fractures | 1 Fractures |
| Confounding fractures for bone union Patient with paralized lower limbs following polio | 1 Fractures | 1 Fractures | 0 Fractures |
| Confounding fractures for bone union Smoking | 5 Fractures | 9 Fractures | 4 Fractures |
| Confounding fractures for bone union Smoking and Obesity | 1 Fractures | 1 Fractures | 0 Fractures |
| Existence of Additional Fractures / Injuries No | 27 Fractures | 53 Fractures | 26 Fractures |
| Existence of Additional Fractures / Injuries Yes | 4 Fractures | 4 Fractures | 0 Fractures |
| Fracture Cause Correction following reduction and osteosynthesis performed at another center | 0 Fractures | 1 Fractures | 1 Fractures |
| Fracture Cause Crush Trauma | 1 Fractures | 1 Fractures | 0 Fractures |
| Fracture Cause Distorsion Trauma | 2 Fractures | 2 Fractures | 0 Fractures |
| Fracture Cause Domestic accident | 1 Fractures | 10 Fractures | 9 Fractures |
| Fracture Cause Domestic accident and Fall | 1 Fractures | 1 Fractures | 0 Fractures |
| Fracture Cause Fall | 4 Fractures | 4 Fractures | 0 Fractures |
| Fracture Cause New fracture on previous synthesis | 1 Fractures | 1 Fractures | 0 Fractures |
| Fracture Cause Non-union | 11 Fractures | 14 Fractures | 3 Fractures |
| Fracture Cause Non-union and Nail breakage | 1 Fractures | 1 Fractures | 0 Fractures |
| Fracture Cause Non-union and Pseudarthrosis after osteotomy in hip dysplasia | 2 Fractures | 2 Fractures | 0 Fractures |
| Fracture Cause Road traffic accident | 5 Fractures | 13 Fractures | 8 Fractures |
| Fracture Cause Trauma | 2 Fractures | 2 Fractures | 0 Fractures |
| Fracture Cause Winter Sports accident | 0 Fractures | 5 Fractures | 5 Fractures |
| Length of Hospital Stay | 4.3 days STANDARD_DEVIATION 2.6 | 4.2 days STANDARD_DEVIATION 2.4 | 4.2 days STANDARD_DEVIATION 2.2 |
| Open or Closed Fracture Closed | 31 Fractures | 57 Fractures | 26 Fractures |
| Open or Closed Fracture Open | 0 Fractures | 0 Fractures | 0 Fractures |
| Operated Side Left | 16 Fractures | 29 Fractures | 13 Fractures |
| Operated Side Right | 15 Fractures | 28 Fractures | 13 Fractures |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 9 Fractures | 19 Fractures | 10 Fractures |
| Sex: Female, Male Male | 22 Fractures | 38 Fractures | 16 Fractures |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 26 |
| other Total, other adverse events | 0 / 30 | 2 / 26 |
| serious Total, serious adverse events | 2 / 30 | 5 / 26 |
Outcome results
Primary
Performance: Fracture Healing
Performance will be assessed by analyzing fracture healing radiographically or clinically. Timepoints at which the data will be collected will be summarized through means.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Performance: Fracture Healing | Fracture healed | 29 Fractures |
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Performance: Fracture Healing | Fracture not healed | 2 Fractures |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate | Performance: Fracture Healing | Fracture healed | 26 Fractures |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate | Performance: Fracture Healing | Fracture not healed | 0 Fractures |
Secondary
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis)
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.
Time frame: Final follow-up visit at minimum 1 year postoperative.
Population: Patients implanted with the device in the Diaphysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis) | EQ-5D-5L Profile | 0.70 Score on a scale | Standard Deviation 0.3 |
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis) | Health State / VAS | 80.7 Score on a scale | Standard Deviation 20.9 |
Secondary
Oxford Shoulder Score (OSS) (Proximal Humerus)
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.
Time frame: Final follow-up visit at minimum 1 year postoperative.
Population: No cases implanted with a Zimmer® Plates and Screws Proximal Humerus Plate were enrolled and analyzed in this study.
Secondary
Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)
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.
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | Adverse Events (AEs) | 0 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | No Adverse Events | 29 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | Serious Adverse Events (SAEs) | 0 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | Adverse Device Effects (ADEs) | 0 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | Serious Adverse Device Effects (SADEs) | 2 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | Serious Adverse Device Effects (SADEs) | 2 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | Adverse Events (AEs) | 3 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | Adverse Device Effects (ADEs) | 0 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | No Adverse Events | 18 Participants |
| Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate | Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects) | Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Tegner Lysholm Knee Score (Proximal Tibia)
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).
Time frame: Final follow-up visit at minimum 1 year postoperative.
Population: Patients implanted with the device in the Proximal Tibia.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate | Tegner Lysholm Knee Score (Proximal Tibia) | 87.4 Score on a scale | Standard Deviation 19 |