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

N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment

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.

Study Overview

• Status: Terminated
• Conditions: Intracapsular Proximal Femur Fracture; Garden Grade I Subcapital Fracture of Femoral Neck; Garden Grade II Subcapital Fracture of Femoral Neck
• Intervention / Treatment: Device: N-Force Screws Augmented with N-Force Blue

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University
  • Missouri
    • Saint Louis, Missouri, United States, 63130
      • Washington University
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Donald B Slocum Research and Education Foundation
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: N-Force Screws; N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.	Device: N-Force Screws Augmented with N-Force Blue; N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With a Reoperation	Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)	Radiographic fracture healing as seen on x-ray and defined using Radiographic Union Score for Hips (RUSH) scoring system. The RUSH quantifies four measures of healing: cortical bridging, cortical fracture disappearance, trabecular consolidation, and trabecular fracture disappearance. Cortical healing is assessed in four anatomic femoral neck regions (anterior, posterior, medial, lateral) and trabecular healing is measured with two assessments (fracture line disappearance and consolidation of matrix). Each of the 10 assessed dimensions of radiographic femoral neck healing are scored 1 to 3, leading to a minimum score of 10 (no signs of healing) and a maximum score of 30 (perfect healing).	6 weeks, 3 months, 6 months, and 12 months
Participant Steinberg Classification at 12 Months	Steinberg Classification is based on the radiographic appearance and location of lesion. It is concise and delineates the progression and extent of Avascular Necrosis (AVN) involvement more accurately. [stage 0:] normal or non-diagnostic radiographs, MRI and bone scan of at risk hip (often contralateral hip involved, or patient has risk factors and hip pain) [stage I:] normal radiograph, abnormal bone scan and/or MRI [stage II:] cystic and sclerotic radiographic changes [stage III:] subchondral lucency or crescent sign [stage IV:] flattening of femoral head, with depression graded into mild: <2 mm moderate: 2-4 mm severe: >4 mm [stage V:] joint space narrowing with or without acetabular involvement [stage VI]: advanced degenerative changes	12 months
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)	The Function IndeX for Trauma (FIX-IT) score is an assessment tool for patients with lower extremity fractures, incorporating pain and the ability to weight-bear. The score utilizes two questions to assess the ability to bear weight and two questions to assess pain at the fracture site. The maximum subtotal for each set of questions is 6 points, yielding a maximum overall score of 12 points and a minimum score (lowest weight bearing and highest pain) of 0 points.	6 weeks, 3 months, 6 months, and 12 months
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)	The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death. The Health Status is scored on a VAS scale of 0 to 100, where 100 ('the best imaginable health state' or 'the best health state you can imagine') to 0 ('the worst imaginable health state' or 'the worst health you can imagine').	6 weeks, 3 months, 6 months, and 12 months
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)	This will be measured using Harris Hip Score. This is quantified on a scale of 0-100 and the domains covered are pain, function, absence of deformity, and range of motion. The score is quantified on a scale of 0-100, with 100 points being the best possible outcome. The domains cover pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points).	6 weeks, 3 months, 6 months, and 12 months
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)	This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.	6 weeks, 3 months, 6 months, and 12 months
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)	This will be measured using the Timed 'Up-and-Go' Test. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.This test is used to assess a person's mobility and requires both static and dynamic balance. Scores of ten seconds or less indicate normal mobility, 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.	6 weeks, 3 months, 6 months, and 12 months
Cost-Effective Analysis	Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.	12 months

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2019
• Primary Completion (Actual): March 11, 2021
• Study Completion (Actual): March 11, 2021

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: May 14, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Augmentation; Cannulated Screws
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone
• Other Study ID Numbers: CMU2017-60T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No