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CompletedNCT03635320TFNAUpdated Jun 6, 2023Results posted

The CHINA TFNA Study

An interventional study of TFNA and PFNA-II in Femur Fractures, sponsored by Synthes GmbH. Completed at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-06.

Sponsored by Synthes GmbH (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
188
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Femur Fractures

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03

In context

Femoral Fractures

186 studies on the registry are indexed under Femoral Fractures; 38 are open to participants now.

This study's enrollment of 188 is above the median of 61 across 114 interventional studies indexed under Femoral Fractures.

Browse Femoral Fractures studies →

Lead sponsor

Synthes GmbH is the lead sponsor of 10 studies on the registry; none are open to participants now.

First submitted after Synthes GmbH became part of Johnson & Johnson.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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
  11. Patients known to be allergic to implant components
  12. Patients who are currently using chemotherapeutics or accepting radiotherapy, use systematically 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
188 participants (actual)

Study arms

  • Experimental
    investigational group

    using Trochanteric Fixation Nail Advanced to treat the fracture

    Device: TFNA

  • Active comparator
    the control group

    Using Proximal Femoral Nail Antirotation to treat the fracture

    Device: PFNA-II

Interventions

  • DeviceTFNA

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

  • DevicePFNA-II

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

06

What researchers measure

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

    Time frame: 24 weeks

07

Results

Posted May 21, 2021

Participant flow

One hundred eighty-eight subjects were included in this study and randomly assigned to a study group; enrollment included 94 in the study group and 94 in the control group. Subjects were clinically followed after surgery at 1, 6, 12 and 24 weeks at the hospital.

Participant flow — Overall Study
MilestoneTFNA Group (Study Group)PFNA-II Group (Control Group)
Started9494
Fas9392
Pps8183
Completed8286
Not completed128
Withdrew: Not implanted the device12
Withdrew: Withdrawal by subject116

Outcome measures

PrimarySuccessful 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

Time frame:
24 weeks
Reported as:
Count of participants · Participants
Successful Fracture Union Rate 24 Weeks After Surgery
ParticipantsTFNA Group (Study Group)PFNA-II Group (Control Group)
Successful Fracture Union Rate 24 Weeks After Surgery8183
Statistical analysis
  • TFNA Group (Study Group) vs PFNA-II Group (Control Group) · Newcombe-Wilson scoring method · 95%ci: 0 · 95% CI -4.53 to 4.42If the lower limit of 95% CI of the difference in the rates of the study group and the control group is greater than the non-inferiority margin of -10%, then the investigational product is considered non-inferior to the control product.

Adverse events

Collected over Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
TFNA Group (Study Group)2/93 (2.2%)18/93 (19.4%)93/93 (100%)
PFNA-II Group (Control Group)1/92 (1.1%)16/92 (17.4%)89/92 (96.7%)
Most frequent serious events
Most frequent serious events
EventTFNA Group (Study Group)PFNA-II Group (Control Group)
Non-device relatedProduct Issues18/9316/92
Device-relatedProduct Issues0/930/92
Most frequent other events
Most frequent other events
EventTFNA Group (Study Group)PFNA-II Group (Control Group)
Non-device relatedProduct Issues93/9389/92
Device relatedProduct Issues0/930/92

Baseline characteristics

3 subjects were not implanted with any device, so total 185 subjects were included in FAS.

Age, Continuous
Age, Continuous(Years)TFNA Group (Study Group)PFNA-II Group (Control Group)Total
Mean77.8 (30 to 91)74.1 (29 to 91)75.9 (29 to 91)
Sex: Female, Male
Sex: Female, Male(Participants)TFNA Group (Study Group)PFNA-II Group (Control Group)Total
Female6459123
Male293362
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)TFNA Group (Study Group)PFNA-II Group (Control Group)Total
Han(Asian)8991180
Others415
Medical history
Medical history(Participants)TFNA Group (Study Group)PFNA-II Group (Control Group)Total
Osteoporosis — Yes5655111
Osteoporosis — No373774
Malnutrition — Yes131427
Malnutrition — No8078158
Anemia — Yes423880
Anemia — No5154105
Hormone deficiency — Yes101
Hormone deficiency — No9292184
Diabetes — Yes281846
Diabetes — No6574139
Smoke within one year — Yes5510
Smoke within one year — No8887175
Drink within one year — Yes358
Drink within one year — No9087177
08

Study locations

9 sites
  • Beijing Jishuitan Hospital
    Beijing, Beijing 100035, China
  • Peking University third Hospital
    Beijing, Beijing 100083, China
  • Chinese PLA General Hospital
    Beijing, Beijing 100853, China
  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
    Guangzhou, Guangdong 510000, China
  • Nanfang Hospital of Southern Medical university
    Guangzhou, Guangdong 510515, China
  • University of Hong Kong shenzhen hospital
    Shenzhen, Guangdong 518000, China
  • The Second AffiliatedHospital of Zhejiang University of Medicine
    Hangzhou, Jiangsu 310009, China
  • Affiliated Hospital of Nantong University
    Nantong, Nantong 226000, China
  • Shanghai First People's Hospital
    Shanghai, Shanghai 200080, China
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2018 to primary completion in May 2020, 17 months.

Results were first posted in May 2021, 1 year after primary completion.

Of 53 interventional studies with no phase under Femoral Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 50. This study's 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 15, 2018
First posted
Aug 17, 2018
StartActual
Dec 13, 2018
Primary completionActual
May 18, 2020
CompletionActual
May 18, 2020
Results first posted
May 21, 2021
Last update
Jun 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03635320
Lead sponsor
Synthes GmbH
Responsible party
Sponsor
First posted
Aug 17, 2018
Start date
Dec 13, 2018
Primary completion
May 18, 2020
Completion
May 18, 2020
Results posted
May 21, 2021
Last update
Jun 6, 2023

Study contacts

Manyi Wang, Dr
principal investigator · Beijing Jishuitan Hospita
Vivian Li, Dr
study director · Johnson & Johnson Medical (Shanghai) Ltd.

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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