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

Stopped early · Not applicable

Conditions studied: Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck

In brief

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.

Key facts

Study ID

NCT03807349

Run by

Zimmer Biomet

People needed

12

Starts

2019-02-21

Expected to finish

2021-03-11

Last updated by the study team

2022-06-08

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stanford University — Stanford, California, United States
• Washington University — St Louis, Missouri, United States
• Donald B Slocum Research and Education Foundation — Eugene, Oregon, United States
• University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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