A Study to Evaluate the Safety and Effectiveness of TRIGEN™ INTERTAN™ (10S Models)

NCT04865146 | Withdrawn

• 1 other identifier: InterTan.2019.13
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 7

Brief 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. The study duration will be Approximately 36 months (6 months start-up, 1 year enrollment, 1 year follow-up, 6 months closeout/study report).

Conditions

Femoral Fractures; Hip Fractures

Keywords

femoral fractures; Nails; TRIGEN; INTERTAN

Outcome Measures

Primary Outcomes (1)

• The Revision Rate

  To evaluate the revision rate for any reason of femoral fractures, treated with INTERTAN 10S Nails at one year post-operation.

  1 year

Secondary Outcomes (7)

• Intraoperative Complications

  Intraoperative

• Radiographic Assessment

  Pre-operative, 6 weeks, 3 months, 6 months, & 1 year

• Time to Union

  Through study completion, approximately 1 year

• Harris Hip Score (HHS)

  6 weeks, 3 months, 6 months, & 1 year

• EuroQol 5-Dimension 5-Level (EQ-5D-5L)

  Pre-operative, 6 weeks, 3 months, 6 months, & 1 year

Study Arms (1)

TRIGEN™ INTERTAN™

Confirmed femoral fracture subjects who are scheduled for repair using INTERTAN 10S Nail

Device: TRIGEN™ INTERTAN™

Interventions

TRIGEN™ INTERTAN™ DEVICE

Femoral fracture treated with INTERTAN 10S Nail

TRIGEN™ INTERTAN™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who plan to be treated using TRIGEN™ INTERTAN™ (10S)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Smith & Nephew Medical (Shanghai) Ltd: lead

Study Sites (7)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

Location

Tang Shan 2rd Hospital

Tangshan, Hebei, 063000, China

Location

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

Shanghai 6th People Hospital

Shanghai, 200025, China

Location

Shanghai Tenth People's Hospital

Shanghai, 200072, China

Location

MeSH Terms

Conditions

Femoral Fractures; Hip Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Hip Injuries

Study Officials

• Yuqiang Sun

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: June 23, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)