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 50 Years
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
