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Femur FracturesTFNANCT03635320

The CHINA TFNA Study

A study testing TFNA and PFNA-II in people with Femur Fractures, run by Synthes GmbH at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Femur Fractures
What is being tested?
TFNA and PFNA-II
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
9 sitesChina
Study dates
13 Dec 2018to 18 May 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Beijing Jishuitan Hospital

    Beijing, Beijing Municipality, 100035

  • Peking University third Hospital

    Beijing, Beijing Municipality, 100083

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou, Guangdong, 510000

  • Nanfang Hospital of Southern Medical university

    Guangzhou, Guangdong, 510515

  • The Second AffiliatedHospital of Zhejiang University of Medicine

    Hangzhou, Jiangsu, 310009

  • Affiliated Hospital of Nantong University

    Nantong, Nantong, 226000

  • Shanghai First People's Hospital

    Shanghai, Shanghai Municipality, 200080

  • University of Hong Kong shenzhen hospital

    Shenzhen, Guangdong, 518000

Other trials in China

About this study

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

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
Being tested
TFNA, PFNA-II
Medical subject headings
Femoral Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TFNADevice

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

  • PFNA-IIDevice

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

Study groups in NCT03635320
Study groupRoleWhat they receive
investigational groupExperimentalusing Trochanteric Fixation Nail Advanced to treat the fracture
Receives: Device: TFNA
the control groupActive comparatorUsing Proximal Femoral Nail Antirotation to treat the fracture
Receives: Device: PFNA-II

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start13 Dec 2018
  3. Primary completion18 May 2020
  4. Study completion18 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03635320
Sponsor's protocol ID
DPS-201502
Other IDs
2018l0002
Acronym
TFNA
Status last verified
Jun 2023
First submitted
15 Aug 2018
Last updated
6 Jun 2023
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 36780014

Questions about this trial

What is this clinical trial studying?

A study testing TFNA and PFNA-II in people with Femur Fractures, run by Synthes GmbH at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful Fracture Union Rate 24 Weeks After Surgery (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03635320, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.

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