Trial Outcomes & Findings for N-Force Screws Augmented With N-Force Blue in Hip Fractures (NCT NCT03807349)

NCT ID: NCT03807349

Last Updated: 2022-06-08

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2022-06-08

Participant Flow

Participant milestones

Measure	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)
Overall Study STARTED	12
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	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)
Overall Study Early Study Termination	9

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	N-Force Screws n=12 Participants 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)
Age, Continuous	77 years n=93 Participants
Sex: Female, Male Female	9 Participants n=93 Participants
Sex: Female, Male Male	3 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	10 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	12 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	N-Force Screws n=12 Participants 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)
Number of Participants With a Reoperation	0 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	N-Force Screws n=12 Participants 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)
Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH) 12 months - RUSH Healing	3 Participants
Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH) 6 weeks - RUSH Healing	5 Participants
Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH) 3 months - RUSH Healing	6 Participants
Number of Participants With Radiographic Fracture Healing of the Intracapsular Femur (RUSH) 6 months - RUSH Healing	5 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Measure	N-Force Screws n=2 Participants 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)
Participant Steinberg Classification at 12 Months Stage 0: Normal radiographs	1 Participants
Participant Steinberg Classification at 12 Months Stage VI: Advanced degenerative changes	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	N-Force Screws n=12 Participants 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)
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur) 6 week - Fix-IT Score	6.4 score on a scale Standard Deviation 2.4
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur) 3 month - Fix-IT Score	8.2 score on a scale Standard Deviation 2.1
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur) 6 month - Fix-IT Score	8.6 score on a scale Standard Deviation 3.5
Average FIX-IT Score (Clinical Fracture Healing of the Intracapsular Femur) 12 month - Fix-IT Score	7 score on a scale Standard Deviation 5.3

SECONDARY outcome

Timeframe: 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 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').

Outcome measures

Measure	N-Force Screws n=12 Participants 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)
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur) 6 week - EQ-5D Score	.605 score on a scale Standard Deviation .257
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur) 3 month - EQ-5D Score	.674 score on a scale Standard Deviation .136
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur) 6 month - EQ-5D Score	.719 score on a scale Standard Deviation .131
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur) 12 month - EQ-5D Score	.542 score on a scale Standard Deviation .420
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur) 6 week - Health Status	68.7 score on a scale Standard Deviation 17.1
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur) 3 month - Health Status	74.4 score on a scale Standard Deviation 25.2
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur) 6 month - Health Status	68 score on a scale Standard Deviation 23.1
Average EQ-5D-5L Score (Clinical Fracture Healing of the Intracapsular Femur) 12 month - Health Status	78.3 score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	N-Force Screws n=12 Participants 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)
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur) 6 months - Harris Hip Score	65.4 score on a scale Standard Deviation 15.7
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur) 6 weeks - Harris Hip Score	55.7 score on a scale Standard Deviation 16
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur) 3 months - Harris Hip Score	59.3 score on a scale Standard Deviation 17.6
Average Harris Hips Score (Clinical Fracture Healing of the Intracapsular Femur) 12 months - Harris Hip Score	68.7 score on a scale Standard Deviation 28.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	N-Force Screws n=12 Participants 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)
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur) 6 Week - Did Patient perform test?	5 Participants
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur) 3 Month - Did Patient perform test?	6 Participants
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur) 6 Month - Did Patient perform test?	4 Participants
Number of Participants That Performed Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur) 1 Year - Did Patient perform test?	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	N-Force Screws n=12 Participants 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)
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur) 6 Week - Average Time to Complete Test (seconds)	21.8 seconds Standard Deviation 9.5
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur) 3 Month - Average Time to Complete Test (seconds)	35.3 seconds Standard Deviation 39.9
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur) 6 Month - Average Time to Complete Test (seconds)	15.5 seconds Standard Deviation 7
Average Participant Time to Complete Timed Up-and-Go Test (Clinical Fracture Healing of the Intracapsular Femur) 1 Year - Average Time to Complete Test (seconds)	11 seconds Standard Deviation 0

SECONDARY outcome

Timeframe: 12 months

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

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

Outcome measures

Outcome data not reported

Adverse Events

N-Force Screws

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	N-Force Screws n=12 participants at risk 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)
Musculoskeletal and connective tissue disorders Leg Pain and failure to thrive	8.3% 1/12 • 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.

Other adverse events

Measure	N-Force Screws n=12 participants at risk 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)
Cardiac disorders Bout of dizziness	8.3% 1/12 • 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.
Musculoskeletal and connective tissue disorders Right knee pain	8.3% 1/12 • 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.
Musculoskeletal and connective tissue disorders Diagnosed with Osteoporosis	8.3% 1/12 • 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.
Musculoskeletal and connective tissue disorders Swollen left knee	8.3% 1/12 • 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.
Musculoskeletal and connective tissue disorders Left groin pain	8.3% 1/12 • 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.
Musculoskeletal and connective tissue disorders Lower Extremity/Foot Swollen	8.3% 1/12 • 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.
Musculoskeletal and connective tissue disorders Left hip pain and weakness after multiple falls	8.3% 1/12 • 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.
Nervous system disorders Strike Alert	8.3% 1/12 • 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.
Eye disorders Scratched eye from contacts	8.3% 1/12 • 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.
Musculoskeletal and connective tissue disorders AVN	8.3% 1/12 • 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.
Product Issues Screw loosening	8.3% 1/12 • 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.

Additional Information

Ryan Boylan, Clinical Affairs Manager

Zimmer Biomet

Phone: 574-371-9784

Email: ryan.boylan@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place