Clinical trial NCT03807349: N-Force Screws Augmented With N-Force Blue in Hip Fractures
Official title: N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intracapsular Proximal Femur Fracture
Garden Grade I Subcapital Fracture of Femoral Neck
Garden Grade II Subcapital Fracture of Femoral Neck
Keywords: Cannulated Screws
Augmentation
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2019-01-16
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With a Reoperation
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)
timeFrame: 6 weeks, 3 months, 6 months, and 12 months
measure: Participant Steinberg Classification at 12 Months
timeFrame: 12 months
measure: Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)
timeFrame: 6 weeks, 3 months, 6 months, and 12 months
measure: Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)
timeFrame: 6 weeks, 3 months, 6 months, and 12 months
measure: Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)
timeFrame: 6 weeks, 3 months, 6 months, and 12 months
measure: Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
timeFrame: 6 weeks, 3 months, 6 months, and 12 months
measure: Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
timeFrame: 6 weeks, 3 months, 6 months, and 12 months
measure: Cost-Effective Analysis
timeFrame: 12 months
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Eugene
country: United States
facility: Donald B Slocum Research and Education Foundation
state: Oregon
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Zimmer Biomet
name: Ryan Boylan, MBA
role: STUDY_DIRECTOR
References: