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The CHINA TFNA Study

NCT03635320 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2023-06-06

Study results available
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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

Interventions

DEVICE

TFNA

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

DEVICE

PFNA-II

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

Sponsors & Collaborators

  • Johnson & Johnson Medical (Shanghai) Ltd.

    collaborator INDUSTRY

  • Synthes GmbH

    lead INDUSTRY

Principal Investigators

  • Manyi Wang, Dr · Beijing Jishuitan Hospita

  • Vivian Li, Dr · Johnson & Johnson Medical (Shanghai) Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-13
Primary Completion
2020-05-18
Completion
2020-05-18
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03635320 on ClinicalTrials.gov