The CHINA TFNA Study

NCT03635320 | Completed Results FDA Device

• 2 other identifiers: DPS-2015022018l0002
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 9

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.

Conditions

Femur Fractures

Outcome Measures

Primary Outcomes (1)

• 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

  24 weeks

Study Arms (2)

investigational group

EXPERIMENTAL

using Trochanteric Fixation Nail Advanced to treat the fracture

Device: TFNA

the control group

ACTIVE COMPARATOR

Using Proximal Femoral Nail Antirotation to treat the fracture

Device: PFNA-II

Interventions

TFNA DEVICE

intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation

investigational group

PFNA-II DEVICE

intramedullary nail ' Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation

the control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Patients with unilateral proximal femur fractures that will be treated with intramedullary nail internal fixation
• According to AO fracture classification, subjects with following fracture type:
• Pertrochanteric (31-A1 and 31-A2)
• Intertrochanteric (31-A3)
• Trochanteric area (31-A1/A2/A3) with diaphyseal extension
• Subject must be comfortable with speaking and understanding questions and responses in an available translated language for patient reported outcomes (PROs)

You may not qualify if:

• Subject does not provide voluntary consent to participate in the study
• The subject is a woman who is pregnant or lactating
• Fractures where the operative treatment will occur more than three weeks after the primary injury
• Patients with femoral head fractures and femoral neck fractures (AO classification 31-B and 31-C)
• Pathological fracture (e.g., primary or metastatic tumor)
• Serious soft tissue injury, judged by the investigator, will impact the union of the fracture, combined vascular injury, and combined osteofascial compartment syndrome
• Multiple systemic injuries judged by researchers not suitable for enrollment, or orthopaedic fractures in other bones at three or more sites
• Revision surgeries (for example, due to malunion, nonunion or infection)
• 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
• Patients with anaesthetic and surgical contraindications
• Patients known to be allergic to implant components
• 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)
• Intemperance judged by researchers not suitable for enrollment (e.g., excessive daily drinking or smoking, drug abuse);
• Patients participated into other clinical trial in the previous 3 months;
• Patients with bad compliance judged by researchers and cannot complete the test according to test scheme, such as schizophrenia and dementia.

Sponsors & Collaborators

• Synthes GmbH: lead
• Johnson & Johnson Medical (Shanghai) Ltd.: collaborator

Study Sites (9)

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, 100035, China

Location

Peking University third Hospital

Beijing, Beijing Municipality, 100083, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, 510000, China

Location

Nanfang Hospital of Southern Medical university

Guangzhou, Guangdong, 510515, China

Location

University of Hong Kong shenzhen hospital

Shenzhen, Guangdong, 518000, China

Location

The Second AffiliatedHospital of Zhejiang University of Medicine

Hangzhou, Jiangsu, 310009, China

Location

Affiliated Hospital of Nantong University

Nantong, Nantong, 226000, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Related Publications (1)

• Zhang L, Pan Z, Zheng X, Wang Q, Tang P, Zhou F, Liu F, Yu B, Leung FKL, Wu A, Hughson S, Chen Z, Blauth M, Rosner A, Sparks C, Wang M. Prospective randomized multicenter noninferiority clinical trial evaluating the use of TFN-advancedTM proximal femoral nailing system (TFNA) for the treatment of proximal femur fracture in a Chinese population. Eur J Trauma Emerg Surg. 2023 Jun;49(3):1561-1575. doi: 10.1007/s00068-023-02231-x. Epub 2023 Feb 13.

  PMID: 36780014 DERIVED

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Results Point of Contact

• Title: Jie, Zhou
• Organization: Johnson & Johnson Medical (Shanghai) Ltd.

JZHOU138@its.jnj.com

+86 18600551010

Study Officials

• Manyi Wang, Dr

  Beijing Jishuitan Hospita

  PRINCIPAL INVESTIGATOR

• Vivian Li, Dr

  Johnson & Johnson Medical (Shanghai) Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: August 15, 2018
• First Posted: August 17, 2018
• Study Start: December 13, 2018
• Primary Completion: May 18, 2020
• Study Completion: May 18, 2020
• Last Updated: June 6, 2023
• Results First Posted: May 21, 2021

Record last verified: 2023-06

Locations

CN (9)