Trials / Completed
CompletedNCT03635320
The CHINA TFNA Study
A Prospective Study Evaluating Trochanteric Fixation Nail Advanced (TFNA) in a Chinese Patient Population
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 188 (actual)
- Sponsor
- Synthes GmbH · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-12-13
- Primary completion
- 2020-05-18
- Completion
- 2020-05-18
- First posted
- 2018-08-17
- Last updated
- 2023-06-06
- Results posted
- 2021-05-21
Locations
9 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03635320. Inclusion in this directory is not an endorsement.