The CHINA TFNA Study

NCT ID: NCT03635320

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-13
• Study Completion Date: 2020-05-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

investigational group

using Trochanteric Fixation Nail Advanced to treat the fracture

Group Type: EXPERIMENTAL

TFNA

Intervention Type: DEVICE

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

the control group

Using Proximal Femoral Nail Antirotation to treat the fracture

Group Type: ACTIVE_COMPARATOR

PFNA-II

Intervention Type: DEVICE

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

Interventions

TFNA

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

Intervention Type: DEVICE

PFNA-II

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Medical (Shanghai) Ltd.

INDUSTRY

Sponsor Role: collaborator

Synthes GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Manyi Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Beijing Jishuitan Hospita

Vivian Li, Dr

Role: STUDY_DIRECTOR

Johnson & Johnson Medical (Shanghai) Ltd.

Locations

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Peking University third Hospital

Beijing, Beijing Municipality, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical university

Guangzhou, Guangdong, China

University of Hong Kong shenzhen hospital

Shenzhen, Guangdong, China

The Second AffiliatedHospital of Zhejiang University of Medicine

Hangzhou, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Nantong, China

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 36780014 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2018l0002

Identifier Type: OTHER

Identifier Source: secondary_id

DPS-201502

Identifier Type: -

Identifier Source: org_study_id