Trial Outcomes & Findings for THP Hip Fracture Plating System Study (NCT NCT03870477)
NCT ID: NCT03870477
Last Updated: 2022-05-12
Results Overview
Revision rate due to device related complication(s) or non-union of the femur.
TERMINATED
NA
1 participants
6 weeks
2022-05-12
Participant Flow
Participant milestones
| Measure |
THP Hip Fracture Plating System
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Overall Study
STARTED
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1
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
THP Hip Fracture Plating System
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Overall Study
Early Study Termination
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1
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Baseline Characteristics
THP Hip Fracture Plating System Study
Baseline characteristics by cohort
| Measure |
THP Hip Fracture Plating System
n=1 Participants
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=5 Participants
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Age, Categorical
>=65 years
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1 Participants
n=5 Participants
|
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Age, Continuous
|
83 years
STANDARD_DEVIATION 0 • n=5 Participants
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Sex: Female, Male
Female
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1 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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|
Race (NIH/OMB)
White
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1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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1 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 weeksPopulation: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
Revision rate due to device related complication(s) or non-union of the femur.
Outcome measures
| Measure |
THP Hip Fracture Plating System
n=1 Participants
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Number of Participants With a Revision
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0 Participants
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SECONDARY outcome
Timeframe: 6 weeksPopulation: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
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 |
THP Hip Fracture Plating System
n=1 Participants
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Number of Participants With Radiographic Fracture Healing of the Femur (RUSH)
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1 Participants
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SECONDARY outcome
Timeframe: 6 weeksPopulation: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
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 |
THP Hip Fracture Plating System
n=1 Participants
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Average FIX-IT Score (Clinical Fracture Healing of the Femur)
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3 score on a scale
Standard Deviation 0
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SECONDARY outcome
Timeframe: 6 weeksPopulation: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
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 |
THP Hip Fracture Plating System
n=1 Participants
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)
6 weeks - Health Status
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75 score on a scale
Standard Deviation 0
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Average EQ-5D-5L Score (Clinical Fracture Healing of the Femur)
6 weeks - EQ-5D Score
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.456 score on a scale
Standard Deviation 0
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SECONDARY outcome
Timeframe: 6 weeksPopulation: At the time of early study termination, 1 subject enrolled into the study; however, the only study completed follow-up visit was the 1-6 week visit.
VAS pain scale is a unidimensional measure of pain intensity. The pain VAS is a continuous scale comprised of a horizontal (HVAS) line, 10 centimeters (100 mm) in length. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 \[100-mm scale\])
Outcome measures
| Measure |
THP Hip Fracture Plating System
n=1 Participants
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Average VAS Pain Score
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16 score on a scale
Standard Deviation 0
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Adverse Events
THP Hip Fracture Plating System
Serious adverse events
| Measure |
THP Hip Fracture Plating System
n=1 participants at risk
THP Hip Fracture Plating System in Intracapsular and Intertrochanteric Femur Fractures
THP Hip Fracture Plating System with telescoping lag screws: The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
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|---|---|
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Gastrointestinal disorders
Dysphagia
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100.0%
1/1 • Number of events 1 • 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. Only (1) subject was enrolled in this study and they completed their 1-6 week follow-up visit, thus adverse event data only exists through the 1-6 week follow-up visit.
ISO definition is not materially different from clinicaltrials.gov definitions.
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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place