Bimalleolar Fractures, Ligament Rupture, Syndesmotic Injuries, Trimalleolar Fractures
Conditions
Brief summary
Over the course of a year from the start of the research study, twenty subjects will be randomized evenly into one of two groups after an informed consent is obtained: a traditional tight rope fixation group or a tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace group. Postoperative reduction was assessed by 3D volumetric ratios and measured by weight-bearing CT at 6-weeks and 3-months post-operation. Patient Reported Outcomes (PROs) were collected preoperatively, and at 6-weeks, 3-months, 6-months, and 1-year post-operation and included the Foot and Ankle Outcome Score and the 36-Item Short Form Survey Instrument (RAND-36) . Differences in volumetric ratios and PROs were evaluated between groups and time periods.
Interventions
DEVICETight rope fixation
a traditional tight rope fixation is performed on one randomized set of subjects
DEVICETight 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 set of subjects to compare syndesmotic volume
Sponsors
Arthrex, Inc.
Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* patients who fit the study injury list
Exclusion criteria
* smokers * prior surgery on ankle * bi-lateral surgery * recent participation in another study within the last 90days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Syndesmotic Volumetric Ratio | 6-Weeks Post-op | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 36-Item Short Form Survey Instrument (RAND-36) Summary Scores | 6 weeks post-operative | The 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. |
| RAND-36 Summary Scores | 3 months post-operative | The 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. |
| Foot and Ankle Outcome Score (FAOS) | 6 weeks post-operative | FAOS 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. |
Countries
United States
Participant flow
Pre-assignment details
Excluded (n = 2) \- Not meeting inclusion criteria: Intact AITFL (n = 2)
Participants by arm
| Arm | Count |
|---|---|
| Tight Rope Fixation Tight rope fixation: a traditional tight rope fixation is performed on one randomized set of subjects | 11 |
| 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 | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Tight Rope Fixation | Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Total |
|---|---|---|---|
| Age, Continuous | 50.5 years STANDARD_DEVIATION 13.3 | 55.9 years STANDARD_DEVIATION 19.3 | 52.9 years STANDARD_DEVIATION 16 |
| FAOS- Daily Life | 19 units on a scale STANDARD_DEVIATION 19 | 33 units on a scale STANDARD_DEVIATION 22 | 25 units on a scale STANDARD_DEVIATION 21 |
| FAOS- Pain | 20.2 units on a scale STANDARD_DEVIATION 19.2 | 30.7 units on a scale STANDARD_DEVIATION 20.9 | 25 units on a scale STANDARD_DEVIATION 20.3 |
| FAOS- QoL | 6 units on a scale STANDARD_DEVIATION 14 | 10 units on a scale STANDARD_DEVIATION 13.6 | 8 units on a scale STANDARD_DEVIATION 13.6 |
| FAOS- Sports/Rec | 7.3 units on a scale STANDARD_DEVIATION 12.5 | 6.1 units on a scale STANDARD_DEVIATION 9.9 | 7 units on a scale STANDARD_DEVIATION 11.2 |
| FAOS- Symptoms | 26.9 units on a scale STANDARD_DEVIATION 21.9 | 40.8 units on a scale STANDARD_DEVIATION 23.4 | 33 units on a scale STANDARD_DEVIATION 23 |
| Height (m) | 1.6 meters STANDARD_DEVIATION 0.1 | 1.7 meters STANDARD_DEVIATION 0.1 | 1.7 meters STANDARD_DEVIATION 0.5 |
| Operative Side Left | 5 Participants | 3 Participants | 8 Participants |
| Operative Side Right | 6 Participants | 6 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 15 Participants |
| RAND-36 MHC | 46.8 units on a scale STANDARD_DEVIATION 11.2 | 51.0 units on a scale STANDARD_DEVIATION 7.7 | 48.7 units on a scale STANDARD_DEVIATION 9.6 |
| RAND-36 PHC | 37.2 units on a scale STANDARD_DEVIATION 11.2 | 39.1 units on a scale STANDARD_DEVIATION 10.7 | 38.1 units on a scale STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 11 participants | 9 participants | 20 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
| Weight (kg) | 85.0 kilograms STANDARD_DEVIATION 16 | 81.0 kilograms STANDARD_DEVIATION 13 | 83.3 kilograms STANDARD_DEVIATION 14.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 9 |
| other Total, other adverse events | 0 / 12 | 0 / 9 |
| serious Total, serious adverse events | 0 / 12 | 1 / 9 |
Outcome results
Primary
Syndesmotic Volumetric Ratio
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
Time frame: 6-Weeks Post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tight Rope Fixation | Syndesmotic Volumetric Ratio | 1.2 Volumetric Ratio | Standard Deviation 0.2 |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Syndesmotic Volumetric Ratio | 1.1 Volumetric Ratio | Standard Deviation 0.1 |
Primary
Syndesmotic Volumetric Ratio
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
Time frame: 3 months post-operative volume
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tight Rope Fixation | Syndesmotic Volumetric Ratio | 1.2 Volumetric Ratio | Standard Deviation 0.3 |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Syndesmotic Volumetric Ratio | 1.1 Volumetric Ratio | Standard Deviation 0.3 |
Secondary
36-Item Short Form Survey Instrument (RAND-36) Summary Scores
The 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.
Time frame: 6 weeks post-operative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tight Rope Fixation | 36-Item Short Form Survey Instrument (RAND-36) Summary Scores | PHC | 35.2 score on a scale |
| Tight Rope Fixation | 36-Item Short Form Survey Instrument (RAND-36) Summary Scores | MHC | 45.3 score on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | 36-Item Short Form Survey Instrument (RAND-36) Summary Scores | PHC | 36.3 score on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | 36-Item Short Form Survey Instrument (RAND-36) Summary Scores | MHC | 47.6 score on a scale |
Secondary
Foot and Ankle Outcome Score (FAOS)
FAOS 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.
Time frame: 1 year post-operative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Symptoms | 73.6 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Sports/Rec | 63.2 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Daily Life | 87.1 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | QoL | 63.2 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Pain | 80.5 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | QoL | 73.8 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Pain | 87 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Symptoms | 80.3 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Daily Life | 90.8 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Sports/Rec | 77.2 units on a scale |
Secondary
Foot and Ankle Outcome Score (FAOS)
FAOS 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.
Time frame: 6 weeks post-operative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Pain | 53.1 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Symptoms | 56.4 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Daily Life | 60.5 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Sports/Rec | 17.3 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | QoL | 29.5 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Daily Life | 72.6 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Pain | 71.6 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | QoL | 38.3 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Symptoms | 69.6 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Sports/Rec | 42.8 units on a scale |
Secondary
Foot and Ankle Outcome Score (FAOS)
FAOS 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.
Time frame: 3 months post-operative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Pain | 70.7 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Symptoms | 69.1 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Daily Life | 80 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Sports/Rec | 46.8 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | QoL | 46.3 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Sports/Rec | 55.6 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Pain | 74.8 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | QoL | 41.2 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Daily Life | 78 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Symptoms | 69.6 units on a scale |
Secondary
Foot and Ankle Outcome Score (FAOS)
FAOS 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.
Time frame: 6 months post-operative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Symptoms | 62 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Sports/Rec | 45 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Daily Life | 75.1 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | QoL | 46.8 units on a scale |
| Tight Rope Fixation | Foot and Ankle Outcome Score (FAOS) | Pain | 70 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | QoL | 64 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Pain | 82.8 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Symptoms | 80.1 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Daily Life | 89.3 units on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | Foot and Ankle Outcome Score (FAOS) | Sports/Rec | 72.8 units on a scale |
Secondary
RAND-36 Summary Scores
The 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.
Time frame: 3 months post-operative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tight Rope Fixation | RAND-36 Summary Scores | PHC | 50.7 score on a scale |
| Tight Rope Fixation | RAND-36 Summary Scores | MHC | 52.2 score on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | RAND-36 Summary Scores | PHC | 44.5 score on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | RAND-36 Summary Scores | MHC | 52.8 score on a scale |
Secondary
RAND-36 Summary Scores
The 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.
Time frame: 6 months post-operative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tight Rope Fixation | RAND-36 Summary Scores | PHC | 48.5 score on a scale |
| Tight Rope Fixation | RAND-36 Summary Scores | MHC | 51.3 score on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | RAND-36 Summary Scores | PHC | 51.9 score on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | RAND-36 Summary Scores | MHC | 55.8 score on a scale |
Secondary
RAND-36 Summary Scores
The 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.
Time frame: 1 year post-operative
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Tight Rope Fixation | RAND-36 Summary Scores | PHC | 49.7 score on a scale |
| Tight Rope Fixation | RAND-36 Summary Scores | MHC | 53.3 score on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | RAND-36 Summary Scores | PHC | 51 score on a scale |
| Tight Rope Fixation w/ AITFL Repair Augmentation With an Internal Brace | RAND-36 Summary Scores | MHC | 54.9 score on a scale |