Trial Outcomes & Findings for Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes. (NCT NCT05062265)
NCT ID: NCT05062265
Last Updated: 2025-02-19
Results Overview
use of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle
COMPLETED
NA
23 participants
6-Weeks Post-op
2025-02-19
Participant Flow
Excluded (n = 2) \- Not meeting inclusion criteria: Intact AITFL (n = 2)
Participant milestones
| Measure |
Tight Rope Fixation
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
11
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Tight Rope Fixation
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.
Baseline characteristics by cohort
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 19.3 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Height (m)
|
1.6 meters
STANDARD_DEVIATION 0.1 • n=5 Participants
|
1.7 meters
STANDARD_DEVIATION 0.1 • n=7 Participants
|
1.7 meters
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Weight (kg)
|
85.0 kilograms
STANDARD_DEVIATION 16.0 • n=5 Participants
|
81.0 kilograms
STANDARD_DEVIATION 13.0 • n=7 Participants
|
83.3 kilograms
STANDARD_DEVIATION 14.5 • n=5 Participants
|
|
Operative Side
Left
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Operative Side
Right
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
FAOS- Pain
|
20.2 units on a scale
STANDARD_DEVIATION 19.2 • n=5 Participants
|
30.7 units on a scale
STANDARD_DEVIATION 20.9 • n=7 Participants
|
25 units on a scale
STANDARD_DEVIATION 20.3 • n=5 Participants
|
|
FAOS- Symptoms
|
26.9 units on a scale
STANDARD_DEVIATION 21.9 • n=5 Participants
|
40.8 units on a scale
STANDARD_DEVIATION 23.4 • n=7 Participants
|
33 units on a scale
STANDARD_DEVIATION 23 • n=5 Participants
|
|
FAOS- Daily Life
|
19 units on a scale
STANDARD_DEVIATION 19 • n=5 Participants
|
33 units on a scale
STANDARD_DEVIATION 22 • n=7 Participants
|
25 units on a scale
STANDARD_DEVIATION 21 • n=5 Participants
|
|
FAOS- Sports/Rec
|
7.3 units on a scale
STANDARD_DEVIATION 12.5 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 9.9 • n=7 Participants
|
7 units on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
FAOS- QoL
|
6 units on a scale
STANDARD_DEVIATION 14 • n=5 Participants
|
10 units on a scale
STANDARD_DEVIATION 13.6 • n=7 Participants
|
8 units on a scale
STANDARD_DEVIATION 13.6 • n=5 Participants
|
|
RAND-36 PHC
|
37.2 units on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
39.1 units on a scale
STANDARD_DEVIATION 10.7 • n=7 Participants
|
38.1 units on a scale
STANDARD_DEVIATION 11 • n=5 Participants
|
|
RAND-36 MHC
|
46.8 units on a scale
STANDARD_DEVIATION 11.2 • n=5 Participants
|
51.0 units on a scale
STANDARD_DEVIATION 7.7 • n=7 Participants
|
48.7 units on a scale
STANDARD_DEVIATION 9.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6-Weeks Post-opuse of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Syndesmotic Volumetric Ratio
|
1.2 Volumetric Ratio
Standard Deviation 0.2
|
1.1 Volumetric Ratio
Standard Deviation 0.1
|
PRIMARY outcome
Timeframe: 3 months post-operative volumeuse of weight-bearing CT scan to measure; In order to compare the 3D syndesmotic volume between groups, the volume ratio was calculated for each patient by dividing the syndesmotic volume of the operative ankle by the syndesmotic volume of the contralateral uninjured ankle
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Syndesmotic Volumetric Ratio
|
1.2 Volumetric Ratio
Standard Deviation 0.3
|
1.1 Volumetric Ratio
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeThe RAND-36 is a health-related quality-of-life questionnaire consisting of 36 questions that measure eight health domains to assess physical and mental health. Scores are 00-100. Higher scores equate to better quality of life and inverse for lower scores. The Physical Health Component and Mental Health Component summary scores were calculated using the oblique method to reduce the risk of underrepresenting mental health scores.
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
36-Item Short Form Survey Instrument (RAND-36) Summary Scores
PHC
|
35.2 score on a scale
Interval 30.0 to 45.0
|
36.3 score on a scale
Interval 32.0 to 41.0
|
|
36-Item Short Form Survey Instrument (RAND-36) Summary Scores
MHC
|
45.3 score on a scale
Interval 39.0 to 52.0
|
47.6 score on a scale
Interval 43.0 to 52.0
|
SECONDARY outcome
Timeframe: 3 months post-operativeThe Short Form-36 (SF-36 or RAND-36) is a health-related quality-of-life questionnaire consisting of 36 questions that measure eight health domains to assess physical and mental health. Scores are 00-100. Higher scores equate to better quality of life and inverse for lower scores. The Physical Health Component and Mental Health Component summary scores were calculated using the oblique method to reduce the risk of underrepresenting mental health scores.
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
RAND-36 Summary Scores
PHC
|
50.7 score on a scale
Interval 44.0 to 58.0
|
44.5 score on a scale
Interval 37.0 to 52.0
|
|
RAND-36 Summary Scores
MHC
|
52.2 score on a scale
Interval 46.0 to 59.0
|
52.8 score on a scale
Interval 47.0 to 58.0
|
SECONDARY outcome
Timeframe: 6 months post-operativeThe SF-36 is a health-related quality-of-life questionnaire consisting of 36 questions that measure eight health domains to assess physical and mental health. Scores are 00-100. Higher scores equate to better quality of life and inverse for lower scores. The Physical Health Component and Mental Health Component summary scores were calculated using the oblique method to reduce the risk of underrepresenting mental health scores.
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
RAND-36 Summary Scores
PHC
|
48.5 score on a scale
Interval 42.0 to 55.0
|
51.9 score on a scale
Interval 45.0 to 59.0
|
|
RAND-36 Summary Scores
MHC
|
51.3 score on a scale
Interval 45.0 to 57.0
|
55.8 score on a scale
Interval 53.0 to 59.0
|
SECONDARY outcome
Timeframe: 1 year post-operativeThe SF-36 is a health-related quality-of-life questionnaire consisting of 36 questions that measure eight health domains to assess physical and mental health. Scores are 00-100. Higher scores equate to better quality of life and inverse for lower scores. The Physical Health Component and Mental Health Component summary scores were calculated using the oblique method to reduce the risk of underrepresenting mental health scores.
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
RAND-36 Summary Scores
PHC
|
49.7 score on a scale
Interval 44.0 to 55.0
|
51 score on a scale
Interval 43.0 to 59.0
|
|
RAND-36 Summary Scores
MHC
|
53.3 score on a scale
Interval 48.0 to 59.0
|
54.9 score on a scale
Interval 50.0 to 60.0
|
SECONDARY outcome
Timeframe: 6 weeks post-operativeFAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Foot and Ankle Outcome Score (FAOS)
Pain
|
53.1 units on a scale
Interval 35.0 to 71.0
|
71.6 units on a scale
Interval 55.0 to 88.0
|
|
Foot and Ankle Outcome Score (FAOS)
Symptoms
|
56.4 units on a scale
Interval 44.0 to 69.0
|
69.6 units on a scale
Interval 58.0 to 82.0
|
|
Foot and Ankle Outcome Score (FAOS)
Daily Life
|
60.5 units on a scale
Interval 45.0 to 76.0
|
72.6 units on a scale
Interval 58.0 to 87.0
|
|
Foot and Ankle Outcome Score (FAOS)
Sports/Rec
|
17.3 units on a scale
Interval 0.0 to 38.0
|
42.8 units on a scale
Interval 14.0 to 71.0
|
|
Foot and Ankle Outcome Score (FAOS)
QoL
|
29.5 units on a scale
Interval 15.0 to 45.0
|
38.3 units on a scale
Interval 12.0 to 65.0
|
SECONDARY outcome
Timeframe: 3 months post-operativeFAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Foot and Ankle Outcome Score (FAOS)
Pain
|
70.7 units on a scale
Interval 57.0 to 84.0
|
74.8 units on a scale
Interval 57.0 to 93.0
|
|
Foot and Ankle Outcome Score (FAOS)
Symptoms
|
69.1 units on a scale
Interval 60.0 to 79.0
|
69.6 units on a scale
Interval 58.0 to 81.0
|
|
Foot and Ankle Outcome Score (FAOS)
Daily Life
|
80 units on a scale
Interval 69.0 to 91.0
|
78 units on a scale
Interval 63.0 to 93.0
|
|
Foot and Ankle Outcome Score (FAOS)
Sports/Rec
|
46.8 units on a scale
Interval 24.0 to 69.0
|
55.6 units on a scale
Interval 30.0 to 82.0
|
|
Foot and Ankle Outcome Score (FAOS)
QoL
|
46.3 units on a scale
Interval 30.0 to 63.0
|
41.2 units on a scale
Interval 25.0 to 58.0
|
SECONDARY outcome
Timeframe: 6 months post-operativeFAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Foot and Ankle Outcome Score (FAOS)
Pain
|
70 units on a scale
Interval 55.0 to 85.0
|
82.8 units on a scale
Interval 70.0 to 95.0
|
|
Foot and Ankle Outcome Score (FAOS)
Symptoms
|
62 units on a scale
Interval 50.0 to 74.0
|
80.1 units on a scale
Interval 72.0 to 88.0
|
|
Foot and Ankle Outcome Score (FAOS)
Daily Life
|
75.1 units on a scale
Interval 59.0 to 91.0
|
89.3 units on a scale
Interval 79.0 to 100.0
|
|
Foot and Ankle Outcome Score (FAOS)
Sports/Rec
|
45 units on a scale
Interval 22.0 to 68.0
|
72.8 units on a scale
Interval 55.0 to 91.0
|
|
Foot and Ankle Outcome Score (FAOS)
QoL
|
46.8 units on a scale
Interval 29.0 to 65.0
|
64 units on a scale
Interval 53.0 to 75.0
|
SECONDARY outcome
Timeframe: 1 year post-operativeFAOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport(Rec), and foot and ankle-related Quality of Life (QOL). The last week is taken into consideration when answering the questionnaire. Standardized answer options are given (% Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.
Outcome measures
| Measure |
Tight Rope Fixation
n=11 Participants
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 Participants
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Foot and Ankle Outcome Score (FAOS)
Pain
|
80.5 units on a scale
Interval 70.0 to 91.0
|
87 units on a scale
Interval 75.0 to 99.0
|
|
Foot and Ankle Outcome Score (FAOS)
Symptoms
|
73.6 units on a scale
Interval 62.0 to 85.0
|
80.3 units on a scale
Interval 67.0 to 94.0
|
|
Foot and Ankle Outcome Score (FAOS)
Daily Life
|
87.1 units on a scale
Interval 78.0 to 96.0
|
90.8 units on a scale
Interval 81.0 to 100.0
|
|
Foot and Ankle Outcome Score (FAOS)
Sports/Rec
|
63.2 units on a scale
Interval 43.0 to 84.0
|
77.2 units on a scale
Interval 58.0 to 97.0
|
|
Foot and Ankle Outcome Score (FAOS)
QoL
|
63.2 units on a scale
Interval 49.0 to 77.0
|
73.8 units on a scale
Interval 58.0 to 89.0
|
Adverse Events
Tight Rope Fixation
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
Serious adverse events
| Measure |
Tight Rope Fixation
n=12 participants at risk
Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects
|
Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace
n=9 participants at risk
Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace: A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Post-operative Pain
|
0.00%
0/12 • 1 year follow up from surgery date.
|
11.1%
1/9 • Number of events 1 • 1 year follow up from surgery date.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place