N-Force Screws Augmented With N-Force Blue in Hip Fractures
Trial ID or NCT#
NCT03807349
Status
NOT RECRUITING
Purpose
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.
Official Title
N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment
Eligibility Criteria
Ages Eligible for Study: Older than 18
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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.
View on ClinicalTrials.gov
