Education and Training
N-Force Screws Augmented With N-Force Blue in Hip Fractures
The objective of this prospective study is to confirm safety and performance of N-Force Screws augmented with N-Force Blue applied in intracapsular proximal femur fracture treatment.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- device: N-Force Screws Augmented with N-Force Blue
Eligibility
Inclusion Criteria:
- Patient has primary Garden I or II intracapsular proximal femur fracture requiring
surgical intervention and is eligible for fixation by three cannulated screws
augmented with N-Force Blue.
- Patient receives operative treatment within 7 days of injury.
- Patient was ambulatory before injury.
- Patient is 50 years of age or older.
Exclusion Criteria:
- Patient has Garden III or IV intracapsular proximal femur fracture.
- Patient has major cognitive impairment (including dementia).
- Patient is on dialysis.
- Patient is not expected to survive follow-up schedule.
- Patient is expected to have problems maintaining follow-up compliance, i.e. patients
with no fixed address, patients not mentally competent to give informed consent, etc.
(Investigator's discretion).
- Patient is a prisoner.
- Patient is known to be pregnant and/or breastfeeding.
- Patient is a known alcohol or drug abuser.
- Patient had previous/has active acute or chronic infections, especially at the site of
operation.
- Patient has non-viable bone, or has areas where surrounding bone is not viable or
capable of supporting and anchoring the implant.
- Patient has traumatic injuries with open wounds or close to the proximal femur
fracture, which are likely to become infected.
- Patient is expected to be non-compliant with recommended post-operative weight-bearing
instructions.
- Physical conditions, in the opinion of the investigator, that would prohibit adequate
implant support or impede healing.
Ages Eligible for Study
50 Years - N/A
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting