Back to resultsN-Force Screws Augmented With N-Force Blue in Hip Fractures (N-Force)
Primary Purpose
Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
N-Force Screws Augmented with N-Force Blue
Sponsored by
About this trial
This is an interventional treatment trial for Intracapsular Proximal Femur Fracture focused on measuring Cannulated Screws, Augmentation
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.
Sites / Locations
- Stanford University
- Washington University
- Donald B Slocum Research and Education Foundation
- University of Utah
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
N-Force Screws
Arm Description
N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.
Outcomes
Primary Outcome Measures
Number of Participants With a Reoperation
Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
Secondary Outcome Measures
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).
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
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.
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').
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).
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.
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.
Cost-Effective Analysis
Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03807349
Brief Title
N-Force Screws Augmented With N-Force Blue in Hip Fractures
Acronym
N-Force
Official Title
N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Sponsor will not pursue CE mark for this product, which precludes need for large PMCF study.
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
March 11, 2021 (Actual)
Study Completion Date
March 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracapsular Proximal Femur Fracture, Garden Grade I Subcapital Fracture of Femoral Neck, Garden Grade II Subcapital Fracture of Femoral Neck
Keywords
Cannulated Screws, Augmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-Force Screws
Arm Type
Other
Arm Description
N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures.
Intervention Type
Device
Intervention Name(s)
N-Force Screws Augmented with N-Force Blue
Intervention Description
N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)
Primary Outcome Measure Information:
Title
Number of Participants With a Reoperation
Description
Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH)
Description
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).
Time Frame
6 weeks, 3 months, 6 months, and 12 months
Title
Participant Steinberg Classification at 12 Months
Description
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
Time Frame
12 months
Title
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur)
Description
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.
Time Frame
6 weeks, 3 months, 6 months, and 12 months
Title
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur)
Description
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').
Time Frame
6 weeks, 3 months, 6 months, and 12 months
Title
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur)
Description
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).
Time Frame
6 weeks, 3 months, 6 months, and 12 months
Title
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
Description
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.
Time Frame
6 weeks, 3 months, 6 months, and 12 months
Title
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur)
Description
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.
Time Frame
6 weeks, 3 months, 6 months, and 12 months
Title
Cost-Effective Analysis
Description
Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Boylan, MBA
Organizational Affiliation
Zimmer Biomet
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Donald B Slocum Research and Education Foundation
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
N-Force Screws Augmented With N-Force Blue in Hip Fractures
We'll reach out to this number within 24 hrs