Clinical trial NCT03635320: The CHINA TFNA Study
Official title: A Prospective Study Evaluating Trochanteric Fixation Nail Advanced (TFNA) in a Chinese Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femur Fractures
Lead sponsor: Synthes GmbH
Sponsor class: INDUSTRY
Collaborators: name: Johnson & Johnson Medical (Shanghai) Ltd.
First posted: 2018-08-17
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Successful Fracture Union Rate 24 Weeks After Surgery
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Jishuitan Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University third Hospital
state: Beijing
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical university
state: Guangdong
city: Shenzhen
country: China
facility: University of Hong Kong shenzhen hospital
state: Guangdong
city: Hangzhou
country: China
facility: The Second AffiliatedHospital of Zhejiang University of Medicine
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Nantong
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
Study officials:
affiliation: Beijing Jishuitan Hospita
name: Manyi Wang, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Johnson & Johnson Medical (Shanghai) Ltd.
name: Vivian Li, Dr
role: STUDY_DIRECTOR
References: