N-Force Screws Augmented With N-Force Blue in Hip Fractures

Primary Endpoint:

• Re-operation within 12 months after initial surgery to promote fracture healing, relieve
pain, treat infection, or improve function.

Secondary Endpoints:

- Radiographic and clinical fracture healing of the proximal femur using standard scoring
methods and patient satisfaction.

- Cost effectiveness

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 older 61 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.