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Sponsor will not pursue CE mark for this product, which precludes need for large PMCF study.
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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.
Primary Endpoint:
• Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
Secondary Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-Force Screws | Other | N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-Force Screws Augmented with N-Force Blue | Device | N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material) |
|
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Boylan, MBA | Zimmer Biomet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Washington University |
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| ID | Title | Description |
|---|---|---|
| FG000 | N-Force Screws | N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures. 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2020 |
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| 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 |
| St Louis |
| Missouri |
| 63130 |
| United States |
| Donald B Slocum Research and Education Foundation | Eugene | Oregon | 97401 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | N-Force Screws | N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures. 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) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Reoperation | Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | 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). | At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects. | Posted | Count of Participants | Participants | 6 weeks, 3 months, 6 months, and 12 months |
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| Secondary | 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 | At the time of early study termination, 12 subjects enrolled into the study. Steinberg classification is only measured for subjects that have completed their 12 month follow-up visit. Although 3 subjects completed the 12 month follow-up, Steinberg Classification is only available on 2 subjects. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | 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. | At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks, 3 months, 6 months, and 12 months |
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| Secondary | 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'). | At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks, 3 months, 6 months, and 12 months |
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| Secondary | 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). | At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks, 3 months, 6 months, and 12 months |
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| Secondary | 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. | At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects; at 3 months, data was available for 9 subjects; at 6 months, data was available for 5 subjects; and, at 12 months, data was available for 3 of the 12 subjects. | Posted | Count of Participants | Participants | 6 weeks, 3 months, 6 months, and 12 months |
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| Secondary | 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. | At the time of early study termination, 12 subjects enrolled into the study. At 6 weeks, data was available for all 12 subjects (only 5 could complete the test); at 3 months, data was available for 9 subjects (only 6 could complete the test); at 6 months, data was available for 5 subjects (only 4 could complete the test); and, at 12 months, data was available for 3 (only 1 could complete the test) of the 12 subjects. | Posted | Mean | Standard Deviation | seconds | 6 weeks, 3 months, 6 months, and 12 months |
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| Secondary | Cost-Effective Analysis | Analysis will be performed comparing N-Force to standard non-augmented cannulated screws. | Cost effective analysis was not performed due to lack of overall study data. | Posted | 12 months |
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Per the protocol, ISO definitions were followed for adverse event data collection. All adverse events were captured for subjects enrolled through 12 months follow-up or study completion (including lost to follow-up), whichever came first.
ISO definition is not materially different from clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | N-Force Screws | N-Force Screws augmented with N-Force Blue in Intracapsular Femur Fractures. 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) | 0 | 12 | 1 | 12 | 8 | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leg Pain and failure to thrive | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bout of dizziness | Cardiac disorders | ISO 14155:2011 | Systematic Assessment |
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| Right knee pain | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Diagnosed with Osteoporosis | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Swollen left knee | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Left groin pain | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Lower Extremity/Foot Swollen | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Left hip pain and weakness after multiple falls | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Strike Alert | Nervous system disorders | ISO 14155:2011 | Systematic Assessment |
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| Scratched eye from contacts | Eye disorders | ISO 14155:2011 | Systematic Assessment |
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| AVN | Musculoskeletal and connective tissue disorders | ISO 14155:2011 | Systematic Assessment |
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| Screw loosening | Product Issues | ISO 14155:2011 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ryan Boylan, Clinical Affairs Manager | Zimmer Biomet | 574-371-9784 | ryan.boylan@zimmerbiomet.com |
| Mar 7, 2022 |
| Prot_SAP_000.pdf |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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