Femur Fractures
Conditions
Brief summary
This is a prospective, multicenter, randomized, controlled, two-arm, non-inferiority study which will be conducted in China to support registration of a cephalomedullary nailing system (TFNA) that currently is available globally. The study will compare the safety and the effectiveness of two intramedullary nails (the investigational group is TFNA and the control group is PFNA-II).Patients enrolled at each site will be randomized in a ratio of 1:1, i.e. one patient assigned to surgery implanted with TFNA for each patient assigned to PFNA-II. Separate block randomization schedules within each site will be used to ensure equal distribution of treatment and control patients. Up to 15 centers will be approved to participate in this study. Patient will be clinically followed after surgery at 1, 6, 12 and 24 weeks. The data up to and including 24 week follow up visit will be used in determining the primary safety and effectiveness of the TFNA. The primary objective of this study is to evaluate whether fracture union rate, evaluated 24 weeks after proximal femur fracture, for the investigational TFNA intramedullary nail is non-inferior to that for currently available control product PFNA-II in patients with proximal femur fractures.
Interventions
DEVICETFNA
intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation
DEVICEPFNA-II
intramedullary nail ' Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
Sponsors
Johnson & Johnson Medical (Shanghai) Ltd.
Synthes GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only patient is masked during the study. He/she will be notified during inform consent that either treatment will be used but they will not be informed exactly which group.
Intervention model description
The study population will include 188 patients with proximal femur fracture undergoing internal fixation using an intramedullary nail. Subjects will be randomized in a 1:1 ratio to receive either the investigational TFNA devices (n=94) or to the control PFNA-II devices (n=94).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Patients with unilateral proximal femur fractures that will be treated with intramedullary nail internal fixation 3. According to AO fracture classification, subjects with following fracture type: 1. Pertrochanteric (31-A1 and 31-A2) 2. Intertrochanteric (31-A3) 3. Trochanteric area (31-A1/A2/A3) with diaphyseal extension 4. Subject must be comfortable with speaking and understanding questions and responses in an available translated language for patient reported outcomes (PROs)
Exclusion criteria
1. Subject does not provide voluntary consent to participate in the study 2. The subject is a woman who is pregnant or lactating 3. Fractures where the operative treatment will occur more than three weeks after the primary injury 4. Patients with femoral head fractures and femoral neck fractures (AO classification 31-B and 31-C) 5. Pathological fracture (e.g., primary or metastatic tumor) 6. Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined vascular injury, and combined osteofascial compartment syndrome 7. Multiple systemic injuries judged by researchers not suitable for enrollment, or orthopaedic fractures in other bones at three or more sites 8. Revision surgeries (for example, due to malunion, nonunion or infection) 9. Concurrent medical conditions judged by researchers not suitable for enrollment, such as: diabetes, metabolic bone disease, post-polio syndrome, poor bone quality, prior history of poor fracture healing, etc 10. Patients with anaesthetic and surgical contraindications 11. Patients known to be allergic to implant components 12. Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically corticosteroid hormone or growth factor, or long-term use sedative hypnotics (continuous use over 3 months) or non-steroidal anti-inflammatory drugs (continuous use over 3 months) 13. Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse); 14. Patients participated into other clinical trial in the previous 3 months; 15. Patients with bad compliance judged by researchers and cannot complete the test according to test scheme, such as schizophrenia and dementia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Fracture Union Rate 24 Weeks After Surgery | 24 weeks | The number of achieving fracuture union at 24 weeks of each group will be counted and the percentage will be calculated. Fracture union success is a composite endpoint; in order for an individual subject's surgery implanted with TFNA or PFNA-II to be considered successful he/she must satisfy all of the following criteria: 1. No focal tenderness or lengthwise percussion pain, or abnormal movement 2. The frontal/lateral X-ray examination shows the vague or no fracture gap, or the continuous callus passing across the fracture line 3. No deformation or breakage is found in the test product |
Countries
China
Participant flow
Recruitment details
One hundred eighty-eight subjects were included in this study and randomly assigned to a study group; enrollment included 94 in the study group and 94 in the control group. Subjects were clinically followed after surgery at 1, 6, 12 and 24 weeks at the hospital.
Pre-assignment details
Subjects required to meet inclustion/exclusion prior to receiving device. 4 subjects were screened but not randomized: 1 subject withdrew ICF before randomization, 1 subject didn't meet inclusion criteria 4, 1 subject met exclusion criteria 9 and 10, 1 subject met exclusion criteria 15.
Participants by arm
| Arm | Count |
|---|---|
| TFNA Group (Study Group) intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation | 93 |
| PFNA-II Group (Control Group) intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation | 92 |
| Total | 185 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | not implanted the device | 1 | 2 |
| Overall Study | Withdrawal by Subject | 11 | 6 |
Baseline characteristics
| Characteristic | TFNA Group (Study Group) | PFNA-II Group (Control Group) | Total |
|---|---|---|---|
| Age, Continuous | 77.8 Years | 74.1 Years | 75.9 Years |
| Medical history Anemia No | 51 Participants | 54 Participants | 105 Participants |
| Medical history Anemia Yes | 42 Participants | 38 Participants | 80 Participants |
| Medical history Diabetes No | 65 Participants | 74 Participants | 139 Participants |
| Medical history Diabetes Yes | 28 Participants | 18 Participants | 46 Participants |
| Medical history Drink within one year No | 90 Participants | 87 Participants | 177 Participants |
| Medical history Drink within one year Yes | 3 Participants | 5 Participants | 8 Participants |
| Medical history Hormone deficiency No | 92 Participants | 92 Participants | 184 Participants |
| Medical history Hormone deficiency Yes | 1 Participants | 0 Participants | 1 Participants |
| Medical history Malnutrition No | 80 Participants | 78 Participants | 158 Participants |
| Medical history Malnutrition Yes | 13 Participants | 14 Participants | 27 Participants |
| Medical history Osteoporosis No | 37 Participants | 37 Participants | 74 Participants |
| Medical history Osteoporosis Yes | 56 Participants | 55 Participants | 111 Participants |
| Medical history Smoke within one year No | 88 Participants | 87 Participants | 175 Participants |
| Medical history Smoke within one year Yes | 5 Participants | 5 Participants | 10 Participants |
| Race/Ethnicity, Customized Han(Asian) | 89 Participants | 91 Participants | 180 Participants |
| Race/Ethnicity, Customized Others | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Female | 64 Participants | 59 Participants | 123 Participants |
| Sex: Female, Male Male | 29 Participants | 33 Participants | 62 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 93 | 1 / 92 |
| other Total, other adverse events | 93 / 93 | 89 / 92 |
| serious Total, serious adverse events | 18 / 93 | 16 / 92 |
Outcome results
Primary
Successful Fracture Union Rate 24 Weeks After Surgery
The number of achieving fracuture union at 24 weeks of each group will be counted and the percentage will be calculated. Fracture union success is a composite endpoint; in order for an individual subject's surgery implanted with TFNA or PFNA-II to be considered successful he/she must satisfy all of the following criteria: 1. No focal tenderness or lengthwise percussion pain, or abnormal movement 2. The frontal/lateral X-ray examination shows the vague or no fracture gap, or the continuous callus passing across the fracture line 3. No deformation or breakage is found in the test product
Time frame: 24 weeks
Population: based on PPS
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TFNA Group (Study Group) | Successful Fracture Union Rate 24 Weeks After Surgery | 81 Participants |
| PFNA-II Group (Control Group) | Successful Fracture Union Rate 24 Weeks After Surgery | 83 Participants |
95% CI: [-4.53, 4.42]Newcombe-Wilson scoring method