Trial Outcomes & Findings for Safety Study of Femoral Neck Fracture System (NCT NCT03721835)
NCT ID: NCT03721835
Last Updated: 2023-09-25
Results Overview
Reoperation for any reason from time of implantation to one-year post operation
TERMINATED
NA
15 participants
1 year
2023-09-25
Participant Flow
Participant milestones
| Measure |
Control Femoral Neck Fracture System
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
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|---|---|
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Overall Study
STARTED
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15
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|
Overall Study
COMPLETED
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3
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Control Femoral Neck Fracture System
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
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|---|---|
|
Overall Study
Participant not able to return
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1
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Overall Study
Lost to Follow-up
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1
|
|
Overall Study
Revision of the components of the study device
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2
|
|
Overall Study
Sponsor terminated study
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6
|
|
Overall Study
Death
|
1
|
|
Overall Study
Sponsor decision
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1
|
Baseline Characteristics
Safety Study of Femoral Neck Fracture System
Baseline characteristics by cohort
| Measure |
Control Femoral Neck Fracture System
n=15 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
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|---|---|
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Age, Continuous
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65.9 years
STANDARD_DEVIATION 15.79 • n=5 Participants
|
|
Sex: Female, Male
Female
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9 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White/caucasian
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14 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race · Black/African American
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0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
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0 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Race · Alaskan native/American indian
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0 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Race · Native Hawaiian/Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
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1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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15 participants
n=5 Participants
|
|
Pre-injury Ambulatory Status
Unaided
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10 Participants
n=5 Participants
|
|
Pre-injury Ambulatory Status
Using a cane
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1 Participants
n=5 Participants
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|
Pre-injury Ambulatory Status
Using a walker
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3 Participants
n=5 Participants
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|
Pre-injury Ambulatory Status
Bed to chair
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 yearPopulation: When study was terminated, only 3 participants completed their one year follow up visit.
Reoperation for any reason from time of implantation to one-year post operation
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=3 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Reoperation Rate at One Year Post-operation
Reoperation
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2 Participants
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Reoperation Rate at One Year Post-operation
No Reoperation
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1 Participants
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SECONDARY outcome
Timeframe: 7 daysDocumentation of any complications related to the implantation of the device
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=15 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Number of Participants With Intraoperative Complications
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0 Participants
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SECONDARY outcome
Timeframe: Operative, 6 weeks, 3 months, 6 months, and 1 yearPopulation: Number of Participants Analyzed indicates the data available for each given time frame as specified.
Appropriate reduction was defined as the principal compressive trabeculae measuring \>160° in the AP view and \<5° of posterior angulation in the lateral view. Fractures were then classified as: * Grade I * Grade II * Grade III If reduction was acceptable in both views, it was classified as Grade I. Grade II was indicative of one plane of malreduction, and Grade III was indicative of malreduction in both radiographic views.
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=15 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Classification of Quality of Fracture Reduction
6 months · Grade II
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0 Participants
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Classification of Quality of Fracture Reduction
6 months · Grade III
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0 Participants
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|
Classification of Quality of Fracture Reduction
1 year · Grade I
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3 Participants
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|
Classification of Quality of Fracture Reduction
1 year · Grade II
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0 Participants
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|
Classification of Quality of Fracture Reduction
1 year · Grade III
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0 Participants
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|
Classification of Quality of Fracture Reduction
6 weeks · Grade II
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0 Participants
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Classification of Quality of Fracture Reduction
3 months · Grade II
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0 Participants
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Classification of Quality of Fracture Reduction
Operative · Grade I
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15 Participants
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Classification of Quality of Fracture Reduction
Operative · Grade II
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0 Participants
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|
Classification of Quality of Fracture Reduction
Operative · Grade III
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0 Participants
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Classification of Quality of Fracture Reduction
6 weeks · Grade I
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12 Participants
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Classification of Quality of Fracture Reduction
6 weeks · Grade III
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0 Participants
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|
Classification of Quality of Fracture Reduction
3 months · Grade I
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9 Participants
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Classification of Quality of Fracture Reduction
3 months · Grade III
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1 Participants
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Classification of Quality of Fracture Reduction
6 months · Grade I
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4 Participants
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SECONDARY outcome
Timeframe: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 yearPopulation: Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated.
The Visual Analogue Scale was simply a line of fixed length, on which the subject marked their experience of pain with a single stroke of a pen. At each specified visit, the participant was asked to indicate their average level of pain from the operated hip over the prior 24 hours using a visual analog scale (VAS). The participant recorded their level of pain on a 100 millimeter visual analog scale with scores ranging from 0 to 100. The scale marked 'no pain' (score of 0) on the left side of the scale and 'severe pain' (score of 100) at the right end of the scale. The participant was instructed to place a vertical mark on the scale, using an ink pen. The Investigator, or designee, measured the distance (in millimeters) from the left end of the VAS scale to the vertical line drawn by the participant. This value was entered in the participant's Case Report Form (CRF) as a measure of the pain associated with the operated hip.
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=15 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Visual Analogue Scale (VAS) for Pain
Pre-Operative
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70.00 score on a scale
Standard Deviation 28.06
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Visual Analogue Scale (VAS) for Pain
1 Year
|
4.30 score on a scale
Standard Deviation 1.53
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Visual Analogue Scale (VAS) for Pain
6 Weeks
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32.30 score on a scale
Standard Deviation 37.88
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Visual Analogue Scale (VAS) for Pain
3 Months
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24.60 score on a scale
Standard Deviation 29.79
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Visual Analogue Scale (VAS) for Pain
6 Months
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12.50 score on a scale
Standard Deviation 25.00
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SECONDARY outcome
Timeframe: Pre-Operative, 6 Weeks, 3 Months, 6 Months, and 1 yearPopulation: Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated.
The EuroQol Five Dimensions (EQ-5D-5L) Questionnaire descriptive system consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), which are each assigned 5 levels: * 1= no problems * 2= slight problems * 3= moderate problems * 4= severe problems * 5= extreme problems The respondent is asked to indicate his/her health using the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for the five dimensions are combined in a 5-digit code describing the respondent's health state with scores ranging from -0.109 to 1 where higher scores indicate a better health state.
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=15 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Quality of Life - EQ-5D-5L
1 Year
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0.8347 score on a scale
Standard Deviation 0.1481
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Quality of Life - EQ-5D-5L
Pre-Operative
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0.3453 score on a scale
Standard Deviation 0.3594
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Quality of Life - EQ-5D-5L
6 Weeks
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0.5164 score on a scale
Standard Deviation 0.2612
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Quality of Life - EQ-5D-5L
3 Months
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0.6724 score on a scale
Standard Deviation 0.2711
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Quality of Life - EQ-5D-5L
6 Months
|
0.8938 score on a scale
Standard Deviation 0.1366
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SECONDARY outcome
Timeframe: 6 Weeks, 3 Months, 6 Months, and 1 yearPopulation: Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated.
The Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in adults by measuring time, in seconds, that it takes the individual to stand from a chair, walk a distance of 10 feet, walk back to the chair, and sit down. The subject will perform the test in their everyday footwear with their walking aid (cane, walker), if applicable. The site will follow the guidelines provided by the Centers for Disease Control and Prevention recording the results on the form provided by the Sponsor.
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=8 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Timed Up and Go (TUG)
3 Months
|
31.4 seconds
Standard Deviation 27.48
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Timed Up and Go (TUG)
6 Months
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18.3 seconds
Standard Deviation 10.53
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|
Timed Up and Go (TUG)
6 Weeks
|
27.1 seconds
Standard Deviation 17.09
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Timed Up and Go (TUG)
1 Year
|
14.3 seconds
Standard Deviation 3.51
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SECONDARY outcome
Timeframe: 6 Weeks, 3 Months, 6 Months, and 1 yearPopulation: Number Analyzed indicates available participant data for each time frame specified. Only 3 participants completed the 1 Year follow up visit when the study was terminated.
The ASLR assessment provides information about the ability of load transfer and motor control strategies in the lumbo/pelvic/hip complex. ASLR will be performed with the subject in a relaxed supine position with legs straight and feet apart. Participants will be instructed to raise their operated leg 20cm above the examination table without bending the knee and without pelvic movement relative to the trunk. A score will be provided by the participant for the operated limb on a six-point Likert scale (0 = not difficult at all, 1 = minimally difficult; 2 = somewhat able to do, 3 = fairly difficult, 4 = very difficult, 5 = unable to do).
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=12 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
1 Year · 3- Fairly difficult
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0 Participants
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
1 Year · 4- Very difficult
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0 Participants
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
1 Year · 5- Not able to do
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0 Participants
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Weeks · 0- Not difficult at all
|
5 Participants
|
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Weeks · 1- Minimally difficult
|
2 Participants
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Weeks · 2- Somewhat able to do
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2 Participants
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Weeks · 3- Fairly difficult
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2 Participants
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Weeks · 4- Very difficult
|
1 Participants
|
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Weeks · 5- Not able to do
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0 Participants
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
3 Months · 0- Not difficult at all
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5 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
3 Months · 1- Minimally difficult
|
1 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
3 Months · 2- Somewhat able to do
|
1 Participants
|
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
3 Months · 3- Fairly difficult
|
1 Participants
|
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
3 Months · 4- Very difficult
|
1 Participants
|
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
3 Months · 5- Not able to do
|
0 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Months · 0- Not difficult at all
|
3 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Months · 1- Minimally difficult
|
1 Participants
|
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Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Months · 2- Somewhat able to do
|
0 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Months · 3- Fairly difficult
|
0 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Months · 4- Very difficult
|
0 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
6 Months · 5- Not able to do
|
0 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
1 Year · 0- Not difficult at all
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3 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
1 Year · 1- Minimally difficult
|
0 Participants
|
|
Active Straight Leg Raise (ASLR) Assessment: Evaluation Score
1 Year · 2- Somewhat able to do
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months post-operativePopulation: Number Analyzed indicates available participant data for the time frame specified.
Construct failure past typical femoral neck fracture healing period (past 6 months) indicated by reported device deficiencies.
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=4 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Number of Participants With Construct Failure
|
0 Participants
|
SECONDARY outcome
Timeframe: During hospitalizationTime spent in hospital measured by the number of days
Outcome measures
| Measure |
Control Femoral Neck Fracture System
n=15 Participants
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Length of Hospital Stay
|
4.90 days
Standard Deviation 1.83
|
Adverse Events
Control Femoral Neck Fracture System
Serious adverse events
| Measure |
Control Femoral Neck Fracture System
n=15 participants at risk
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Product Issues
Screw fracture (Posterior, Proximal), Screw back out (Anterior, Proximal)
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the time of surgery through the 1 year follow-up
|
|
Nervous system disorders
End stage Parkinson's Disease
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the time of surgery through the 1 year follow-up
|
|
Cardiac disorders
St. Elevation Myocardial Infarction
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the time of surgery through the 1 year follow-up
|
|
Infections and infestations
Foot infection
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the time of surgery through the 1 year follow-up
|
|
Product Issues
Non union
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the time of surgery through the 1 year follow-up
|
Other adverse events
| Measure |
Control Femoral Neck Fracture System
n=15 participants at risk
This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture
CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws
|
|---|---|
|
Injury, poisoning and procedural complications
Closed head injury
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the time of surgery through the 1 year follow-up
|
|
Injury, poisoning and procedural complications
Ground level fall
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the time of surgery through the 1 year follow-up
|
|
Skin and subcutaneous tissue disorders
Redness to right foot
|
6.7%
1/15 • Number of events 1 • Adverse events were collected from the time of surgery through the 1 year follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60