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

Zimmer Biomet

Status

Terminated

Conditions

Intracapsular Proximal Femur Fracture

Garden Grade II Subcapital Fracture of Femoral Neck

Garden Grade I Subcapital Fracture of Femoral Neck

Treatments

Device: N-Force Screws Augmented with N-Force Blue

Study type

Interventional

Funder types

Industry

Identifiers

NCT03807349

CMU2017-60T

Details and patient eligibility

About

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.

Full description

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

Enrollment

12 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.