The CHINA TFNA Study (TFNA)

• ClinicalTrials.gov Identifier: NCT03635320
• Recruitment Status: Completed
• First Posted: August 17, 2018
• Results First Posted: May 21, 2021
• Last Update Posted: May 21, 2021
• Sponsor: Synthes GmbH
• Collaborator: Johnson & Johnson Medical (Shanghai) Ltd.
• Information provided by (Responsible Party): Synthes GmbH

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Femur Fractures	Device: TFNA; Device: PFNA-II	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment

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).

• Masking: Single (Participant)
• 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.
• Primary Purpose: Treatment
• Official Title: A Prospective Study Evaluating Trochanteric Fixation Nail Advanced (TFNA) in a Chinese Patient Population
• Actual Study Start Date: December 12, 2018
• Actual Primary Completion Date: May 18, 2020
• Actual Study Completion Date: May 18, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: investigational group; using Trochanteric Fixation Nail Advanced to treat the fracture	Device: TFNA; intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation
Active Comparator: the control group; Using Proximal Femoral Nail Antirotation to treat the fracture	Device: PFNA-II; intramedullary nail ' Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation

Outcome Measures

Primary Outcome Measures :

1. Successful Fracture Union Rate 24 Weeks After Surgery [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Beijing

Beijing Jishuitan Hospital

Beijing, Beijing, China, 100035

Peking University third Hospital

Beijing, Beijing, China, 100083

Chinese PLA General Hospital

Beijing, Beijing, China, 100853

China, Guangdong

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, China, 510000

Nanfang Hospital of Southern Medical university

Guangzhou, Guangdong, China, 510515

University of Hong Kong shenzhen hospital

Shenzhen, Guangdong, China, 518000

China, Jiangsu

The Second AffiliatedHospital of Zhejiang University of Medicine

Hangzhou, Jiangsu, China, 310009

China, Nantong

Affiliated Hospital of Nantong University

Nantong, Nantong, China, 226000

China, Shanghai

Shanghai First People's Hospital

Shanghai, Shanghai, China, 200080

Sponsors and Collaborators

Synthes GmbH

Johnson & Johnson Medical (Shanghai) Ltd.

Investigators

• Principal Investigator: Manyi Wang, Dr; Beijing Jishuitan Hospita
• Study Director: Vivian Li, Dr; Johnson & Johnson Medical (Shanghai) Ltd.

  Study Documents (Full-Text)

Documents provided by Synthes GmbH:

Study Protocol  [PDF] January 8, 2019

Statistical Analysis Plan  [PDF] May 19, 2020

More Information

• Responsible Party: Synthes GmbH
• ClinicalTrials.gov Identifier: NCT03635320
• Other Study ID Numbers: DPS-201502; 2018l0002 ( Other Identifier: CFDA )
• First Posted: August 17, 2018
• Results First Posted: May 21, 2021
• Last Update Posted: May 21, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Leg Injuries