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The CHINA TFNA Study (TFNA)

Primary Purpose

Femur Fractures

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TFNA

PFNA-II

About this trial

This is an interventional treatment trial for Femur Fractures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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:
1. Pertrochanteric (31-A1 and 31-A2)
2. Intertrochanteric (31-A3)
3. 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)

Exclusion Criteria:

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.

Sites / Locations

Beijing Jishuitan Hospital
Peking University third Hospital
Chinese PLA General Hospital
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Nanfang Hospital of Southern Medical university
University of Hong Kong shenzhen hospital
The Second AffiliatedHospital of Zhejiang University of Medicine
Affiliated Hospital of Nantong University
Shanghai First People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

investigational group

the control group

Arm Description

using Trochanteric Fixation Nail Advanced to treat the fracture

Using Proximal Femoral Nail Antirotation to treat the fracture

Outcomes

Primary Outcome Measures

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: No focal tenderness or lengthwise percussion pain, or abnormal movement The frontal/lateral X-ray examination shows the vague or no fracture gap, or the continuous callus passing across the fracture line No deformation or breakage is found in the test product

Secondary Outcome Measures

Full Information

NCT ID

NCT03635320

First Posted

August 15, 2018

Last Updated

June 2, 2023

Sponsor

Synthes GmbH

Collaborators

Johnson & Johnson Medical (Shanghai) Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03635320

Brief Title

The CHINA TFNA Study

Acronym

TFNA

Official Title

A Prospective Study Evaluating Trochanteric Fixation Nail Advanced (TFNA) in a Chinese Patient Population

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

December 13, 2018 (Actual)

Primary Completion Date

May 18, 2020 (Actual)

Study Completion Date

May 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Synthes GmbH

Collaborators

Johnson & Johnson Medical (Shanghai) Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femur Fractures

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

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.

Allocation

Randomized

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

investigational group

Arm Type

Experimental

Arm Description

using Trochanteric Fixation Nail Advanced to treat the fracture

Arm Title

the control group

Arm Type

Active Comparator

Arm Description

Using Proximal Femoral Nail Antirotation to treat the fracture

Intervention Type

Device

Intervention Name(s)

TFNA

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

PFNA-II

Intervention Description

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

Primary Outcome Measure Information:

Title

Successful Fracture Union Rate 24 Weeks After Surgery

Description

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Manyi Wang, Dr

Organizational Affiliation

Beijing Jishuitan Hospita

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Vivian Li, Dr

Organizational Affiliation

Johnson & Johnson Medical (Shanghai) Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

Beijing Jishuitan Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100035

Country

China

Facility Name

Peking University third Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100083

Country

China

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510000

Country

China

Facility Name

Nanfang Hospital of Southern Medical university

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

Facility Name

University of Hong Kong shenzhen hospital

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518000

Country

China

Facility Name

The Second AffiliatedHospital of Zhejiang University of Medicine

City

Hangzhou

State/Province

Jiangsu

ZIP/Postal Code

310009

Country

China

Facility Name

Affiliated Hospital of Nantong University

City

Nantong

State/Province

Nantong

ZIP/Postal Code

226000

Country

China

Facility Name

Shanghai First People's Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200080

Country

China

12. IPD Sharing Statement

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The CHINA TFNA Study

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