Femur Fracture Clinical Trial
Official title:
A Prospective Study to Investigate Postoperative Real Life Weight Bearing Measured in Patients Treated With a Trochanter Fixation Nail Advanced (TFNA)
Verified date | September 2020 |
Source | AO Innovation Translation Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study documents real life weight bearing in patients treated with a TFNA, who are allowed for immediate weight bearing as tolerated.
Status | Terminated |
Enrollment | 16 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Age 18 years and older - Patients treated with the TFNA; i.e. according to the technique guide and the indications for use, patients who presented any of the following conditions: - Stable or unstable pertrochanteric fractures - Intertrochanteric fractures - Basal neck fractures - Combinations of pertrochanteric, intertrochanteric, and basal neck fractures - Patients who were able to walk before the fracture and are prescribed full weight bearing as tolerated post-surgery - Ability to understand the content of the patient information / informed consent form - Willingness and ability to participate in the study according to the clinical investigation plan - Signed and dated ethical committee approved written informed consent according to the local regulations Exclusion Criteria: - Patients who are not allowed to full weight bearing as tolerated post-surgery - Any condition, which impairs weight bearing (e.g. additional acute fracture on the ipsilateral and/or contralateral side, pain) - Patients, who due to their condition, are in opinion of the Prinicipal Investigator (PI) unable to complete a reliable assessment - Pregnancy or women planning to conceive within the study period - Participation in any other medical device or medicinal product registry within the previous month that could, in opinion of the PI, influence the results of the present study |
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Innsbruck | Innsbruck | |
Switzerland | Kantonsspital Baselland | Binningen |
Lead Sponsor | Collaborator |
---|---|
AO Innovation Translation Center |
Austria, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Weight bearing | Time course of the weight bearing difference between the operated and the healthy legs within 3 months after surgery. | 3 months |
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