N-Force Screws Augmented With N-Force Blue in Hip Fractures (NCT03807349) | Clinical Trial Compass
TerminatedNot Applicable
N-Force Screws Augmented With N-Force Blue in Hip Fractures
Stopped: Sponsor will not pursue CE mark for this product, which precludes need for large PMCF study.
United States12 participantsStarted 2019-02-21
Plain-language summary
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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …