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



Status:Not yet recruiting
Conditions:Orthopedic, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:61 - Any
Updated:3/14/2019
Start Date:March 2019
End Date:January 2022
Contact:Ryan Boylan
Email:ryan.boylan@zimmerbiomet.com
Phone:5743719784

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N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment

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.

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.
We found this trial at
2
sites
55 Coburg Road
Eugene, Oregon 97408
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Eugene, OR
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Springfield, Illinois 62703
Principal Investigator: Matthew Gardner
Phone: 217-528-7541
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Springfield, IL
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