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

Reoperation after initial surgery to promote fracture healing, relieve pain, treat infection, or improve function.

Time frame: 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. 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

Population: 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.

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

Population: 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.

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

Population: 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.

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

Population: 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.

Analysis will be performed comparing N-Force to standard non-augmented cannulated screws.

Time frame: 12 months

Population: Cost effective analysis was not performed due to lack of overall study data.

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

Population: 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.

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

Population: 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.

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

Population: 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.