Femoral FracturesNCT04865146
A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models)
An observational study of Femoral Fractures and Hip Fractures, run by Smith & Nephew Medical (Shanghai) Ltd at 7 sites in China.
Trial summary
This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation. The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites are involved. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Fractures, Hip Fractures
- What is being tested?
- TRIGEN™ INTERTAN™
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 7 sitesChina
- Study dates
- 23 Jun 2022to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects who plan to be treated using TRIGEN™ INTERTAN™ (10S)
Who may be able to join
- Subjects who sign the informed consent form (ICF) voluntarily.
- Subjects who have a femoral fracture and are scheduled for repair using an INTERTAN 10S Nail.
- Male or female subjects aged 18 years or older, with mature bone development at time of implantation.
- Subjects who agree to follow all study visits and procedures.
Who cannot join
- Subjects with known hypersensitivity to the device or implant materials.
- Subjects in which use of the device would cross open epiphyseal plate(s).
- Subjects with complex intertrochanteric and femoral neck fractures.
- Subjects with an existing condition that predisposes them to a poor outcome, such as blood supply limitations, insufficient bone quality or quantity, obliterated medullary canal, previous infections or other conditions which tend to retard healing.
- Subjects not suitable for operation due to obvious local or systemic infection.
- Subjects who are unable to tolerate anesthesia and surgery due to cardiopulmonary failure or other serious diseases.
Show all 16Show fewer
- Subjects with a congenital or acquired bony deformity.
- Subjects with Body Mass Index (BMI) of ≥ 35.
- Subjects with hypovolemia, hypothermia, or coagulopathy.
- Subject is immunosuppressed, has an autoimmune disorder or an immunosuppressive disorder. For examples, subjects are on immunosuppressive therapy (cortisol at large dose, cytotoxic drugs, antilymphocytic serum or irradiation at large doses) or has acquired immunodeficiency syndrome (AIDS).
- Subjects with any existing hardware that would preclude the use of the nail.
- Subjects with mental or emotional conditions or any other clinical conditions that, in the opinion of the Investigator, would preclude cooperation and compliance with the rehabilitation regimen.
- Subjects with medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
- Subject is a woman who is pregnant or lactating, or intends to become pregnant during the course of the study follow-up.
- Subjects who have participated in any other clinical trial within 3 months of Screening.
- Subjects who have participated previously in this clinical study and were withdrawn for any reason.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University Third Hospital
Beijing, 100191
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Shanghai 6th People Hospital
Shanghai, 200025
Shanghai Tenth People's Hospital
Shanghai, 200072
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Tang Shan 2rd Hospital
Tangshan, Hebei, 063000
About this study
Official title: A Multicenter, Post Market, Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ Intertrochanteric Antegrade Nails (10S Models) for the Treatment of Femoral Fracture in Chinese Subjects
This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation. The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites are involved. The study duration will be Approximately 36 months (6 months start-up, 1 year enrollment, 1 year follow-up, 6 months closeout/study report).
Read the detailed description
Background:
The INTERTAN nail was designed to improve upon existing intramedullary nail systems. INTERTAN nails utilize two interlocking screws, thereby improving controlled intertochanteric fracture compression and post-surgical stability.
Purpose:
Evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation
Objectives:
- Primary Objective: To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation
- Secondary Objective: To generate safety and effectiveness evidence for INTERTAN 10S Nails via the collection of functional outcomes, quality of life, and safety data
Research participants / locations:
The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites in China are involved.
- Conditions
- Femoral Fractures, Hip Fractures
- Being tested
- TRIGEN™ INTERTAN™
- Keywords
- femoral fractures, Nails, TRIGEN, INTERTAN
- Medical subject headings
- Femoral Fractures, Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIGEN™ INTERTAN™Device
Femoral fracture treated with INTERTAN 10S Nail
| Study group | Role | What they receive |
|---|---|---|
| TRIGEN™ INTERTAN™ | Confirmed femoral fracture subjects who are scheduled for repair using INTERTAN 10S Nail Receives: Device: TRIGEN™ INTERTAN™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Revision Rate
To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation.
Measured: 1 year
Secondary outcomes (7)
Intraoperative Complications
Documentation of any complications related to the implantation of the device. Potential complications of this type of surgery include, but are not limited to, those listed below.
- Loosening, bending, cracking or fracture of the implant components
- Limb shortening or loss of anatomical position, accompanied with bone nonunion or with rotation or angulated malunion
- Infections, both deep and superficial
- Irritational injury of soft tissues, including impingement syndrome
- Supracondylar fractures from retrograde nailing
- Macrophage and foreign body reactions adjacent to implants
Measured: Intraoperative
Radiographic Assessment
Full-length standing radiographs, standard anteroposterior (AP), and lateral radiographs of lower extremities taken prior to surgery and at all follow-up time points to identify the presence of bone healing result, normal fracture healing and disturbed fracture healing.
Measured: Pre-operative, 6 weeks, 3 months, 6 months, & 1 year
Time to Union
To evaluate the bone healing during each visit by achieving radiographic union.
Measured: Through study completion, approximately 1 year
Harris Hip Score (HHS)
The Harris Hip Score is a joint specific score that consists of 10 items covering domains of pain (1 item, 0-44 points), function (7 items, 0-47 points), functional activities, absence of deformity (1 item, 0 or 4 points), and hip range of motion (2 items, 0-5 points). Scores range from 0 (worst) to 100 (best).
Measured: 6 weeks, 3 months, 6 months, & 1 year
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
The EQ-5D-5L is a standardized instrument for use as a measurement of health outcome. It consists of a descriptive system with 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned five levels (no problems, slight problems, moderate problems, severe problems and extreme problems), as well as, a Visual Analogue Scale (VAS) where subjects indicate a numerical value from 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state.
The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the dimensions. This decision results in a 1- digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.
Measured: Pre-operative, 6 weeks, 3 months, 6 months, & 1 year
Time to Return to Full Weight-Bearing
To evaluate the bone healing during each visit by achieving return to full weight-bearing.
Measured: Post-operatively through study completion, approximately 12 months
Length of Stay
Length of stay in days participant spends in hospital.
Measured: During hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start23 Jun 2022
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: Change on clinical and marketing strategy for intramedullary devices
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew Medical (Shanghai) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuqiang Sun, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865146
- Sponsor's protocol ID
- InterTan.2019.13
- Status last verified
- Feb 2024
- First submitted
- 26 Apr 2021
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Post Market, Clinical Follow-Up Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ Intertrochanteric Antegrade Nails (10S Models) for the Treatment of Femoral Fracture in Chinese Subjects
- ClinicalTrials.gov ID
- NCT04865146
- Acronym / sponsor ID
- InterTan.2019.13
- Conditions
- Femoral Fractures, Hip Fractures
- Keywords
- femoral fractures, Nails, TRIGEN, INTERTAN
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Change on clinical and marketing strategy for intramedullary devices
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Smith & Nephew Medical (Shanghai) LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-market study to evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation. The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites are involved. The study duration will be Approximately 36 months (6 months start-up, 1 year enrollment, 1 year follow-up, 6 months closeout/study report).
Detailed description
Background:
The INTERTAN nail was designed to improve upon existing intramedullary nail systems. INTERTAN nails utilize two interlocking screws, thereby improving controlled intertochanteric fracture compression and post-surgical stability.
Purpose:
Evaluate the revision rate of femoral fractures, treated with INTERTAN 10S Nails at one-year post-operation
Objectives:
- Primary Objective: To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation
- Secondary Objective: To generate safety and effectiveness evidence for INTERTAN 10S Nails via the collection of functional outcomes, quality of life, and safety data
Research participants / locations:
The study will enroll Approximately 180 subjects with femoral fractures, Approximately 7 sites in China are involved.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRIGEN™ INTERTAN™ | – | Device: TRIGEN™ INTERTAN™Confirmed femoral fracture subjects who are scheduled for repair using INTERTAN 10S Nail |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who plan to be treated using TRIGEN™ INTERTAN™ (10S)
Key inclusion criteria (4 listed)
- Subjects who sign the informed consent form (ICF) voluntarily.
- Subjects who have a femoral fracture and are scheduled for repair using an INTERTAN 10S Nail.
- Male or female subjects aged 18 years or older, with mature bone development at time of implantation.
- Subjects who agree to follow all study visits and procedures.
Key exclusion criteria (16 listed)
- Subjects with known hypersensitivity to the device or implant materials.
- Subjects in which use of the device would cross open epiphyseal plate(s).
- Subjects with complex intertrochanteric and femoral neck fractures.
- Subjects with an existing condition that predisposes them to a poor outcome, such as blood supply limitations, insufficient bone quality or quantity, obliterated medullary canal, previous infections or other conditions which tend to retard healing.
- Subjects not suitable for operation due to obvious local or systemic infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIGEN™ INTERTAN™Femoral fracture treated with INTERTAN 10S Nail | Device | TRIGEN™ INTERTAN™ |
Primary outcome
The Revision Rate
Time frame: 1 year
To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation.
7 secondary outcomes
Intraoperative Complications
Time frame: Intraoperative
Radiographic Assessment
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, & 1 year
Time to Union
Time frame: Through study completion, approximately 1 year
Harris Hip Score (HHS)
Time frame: 6 weeks, 3 months, 6 months, & 1 year
EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Time frame: Pre-operative, 6 weeks, 3 months, 6 months, & 1 year
Time to Return to Full Weight-Bearing
Time frame: Post-operatively through study completion, approximately 12 months
Length of Stay
Time frame: During hospitalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuqiang Sun principal investigator
Shanghai 6th People's Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fractures and Hip Fractures, run by Smith & Nephew Medical (Shanghai) Ltd at 7 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 4 inclusion and 16 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: withdrawn, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The Revision Rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2024.