N-Force Screws Augmented With N-Force Blue in Hip Fractures (N-Force)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03807349|
Recruitment Status : Terminated (Sponsor will not pursue CE mark for this product, which precludes need for large PMCF study.)
First Posted : January 16, 2019
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Intracapsular Proximal Femur Fracture Garden Grade I Subcapital Fracture of Femoral Neck Garden Grade II Subcapital Fracture of Femoral Neck||Device: N-Force Screws Augmented with N-Force Blue||Not Applicable|
• Re-operation within 12 months after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
- Radiographic and clinical fracture healing of the proximal femur using standard scoring methods and patient satisfaction.
- Cost effectiveness
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||N-Force Screws Augmented With N-Force Blue in Intracapsular Proximal Femur Fracture Treatment|
|Actual Study Start Date :||February 21, 2019|
|Actual Primary Completion Date :||March 11, 2021|
|Actual Study Completion Date :||March 11, 2021|
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)
- Re-operation Rate [ Time Frame: 12 months ]Re-operation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.
- Radiographic Fracture Healing of the Intracapsular Femur (RUSH) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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).
- Radiographic Fracture Healing of the Intracapsular Femur (Steinberg Classification) [ Time Frame: 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
- Clinical Fracture Healing of the Intracapsular Femur (FIX-IT) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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.
- Clinical Fracture Healing of the Intracapsular Femur (EQ-5D-5L) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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.
- Clinical Fracture Healing of the Intracapsular Femur (Harris Hip) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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).
- Clinical Fracture Healing of the Intracapsular Femur (Timed Up-and-Go) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]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 [ Time Frame: 12 months ]Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03807349
|United States, California|
|Stanford, California, United States, 94305|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63130|
|United States, Oregon|
|Donald B Slocum Research and Education Foundation|
|Eugene, Oregon, United States, 97401|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84108|
|Study Director:||Kacy Arnold, RN MBA||Zimmer Biomet|