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