Equinus Contracture
Conditions
Keywords
pilon, tibial plafond, botox, ankle dorsiflexion, ankle functionality, ankle range of motion
Brief summary
The purpose of this study is to determine if botulinum toxin type A (Botox) injections, at the time of surgery for pilon fractures, will improve ankle range-of-motion and functionality.
Detailed description
To determine if the use of Botulinum toxin A intramuscular injections of the gastrocsoleus complex in patients with operatively treated tibial plafond fractures will result in: 1. increased ankle dorsiflexion when compared to controls 2. increased ankle functionality as measured by the FAAM, and quality of life as measured by the SF-36, when compared to controls 3. a higher proportion of patients achieving at least 10 degrees of dorsiflexion when compared to controls
Interventions
DRUGBotulinum toxin type A
At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U
DRUGsodium chloride
At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U). 45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 and older with a tibial plafond fracture to be treated by a staged protocol involving primary external fixation and definitive fixation within 3 weeks from the injury. (Non-definitive, interval procedures such as repeat irrigation and debridement and fibular fixation are allowed.)
Exclusion criteria
* Younger than 18 years of age * Significant traumatic brain injury or cognitive disability that would interfere with post-operative rehabilitation and study questionnaires * Nerve, vascular, or tendon injury of the lower leg: injury to the tibial or peroneal motor nerves, injury to the posterior tibial artery requiring repair, or laceration of tendons that are involved in plantar flexion or dorsiflexion of the ankle which require repair * History of prior lower extremity fracture to the tibia or ankle of the affected limb. * Incarcerated patients. * Patients unable or unwilling to return for follow-up examination. * Pregnant or lactating patients. * History of disease affecting the neuromuscular junction (ex: myasthenia gravis). * Use of aminoglycoside antibiotics at the time of definitive fixation. * Ipsilateral foot injury that will impair dorsiflexion exercises: Lisfranc injuries, fractures or dislocations of the talus, calcaneus, navicular, cuboid, cuneiforms, or metatarsals (phalanx fractures or dislocations will not be excluded). * Patients receiving Botulinum Toxin A for other reasons. * Patients with a known hypersensitivity to Botulinum toxin A. * Gustilo Anderson type III B and C. * Patients with a weight greater than 115 kg - to ensure proper injection locations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ankle Dorsiflexion of Injured Extremity | 6 month follow-up visit | The difference in ankle dorsiflexion between the injured and un-injured ankles as measured with goniometer 6 month from surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-36 (SF-36) Health Related Quality of Life | 12 month follow-up visits | The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best) |
| Ankle Pain at 6 Month | 6 month follow-up visit | Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. |
| Short Form-36 (SF-36)Health Related Quality of Life | 6 month follow-up visit | The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best) |
| Functional Status of the Ankle at 6 Month | 6 month follow-up visit | The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction. |
| Functional Status of the Ankle at 12 Month | 12 month follow-up visit | The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. A higher score represents a higher level of physical function. |
| Ankle Pain at 12 Month | 12 month follow-up visit | Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Botulinum Toxin Type A Botox: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).
45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U | 5 |
| 0.9% Sodium Chloride Placebo: At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).
45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U | 5 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
Baseline characteristics
| Characteristic | Botulinum Toxin Type A | 0.9% Sodium Chloride | Total |
|---|---|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 8.9 | 42.0 years STANDARD_DEVIATION 11 | 43.6 years STANDARD_DEVIATION 9.6 |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 5 Participants | 4 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Ankle Dorsiflexion of Injured Extremity
The difference in ankle dorsiflexion between the injured and un-injured ankles as measured with goniometer 6 month from surgery.
Time frame: 6 month follow-up visit
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Botox | Ankle Dorsiflexion of Injured Extremity | -3.8 degrees |
| Placebo | Ankle Dorsiflexion of Injured Extremity | 11.8 degrees |
Secondary
Ankle Pain at 12 Month
Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: 12 month follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox | Ankle Pain at 12 Month | Pain Severity (BPI) | 2.92 units on a scale | Standard Deviation 2.5 |
| Botox | Ankle Pain at 12 Month | Pain Interference (BPI) | 4.1 units on a scale | Standard Deviation 3.5 |
| Placebo | Ankle Pain at 12 Month | Pain Severity (BPI) | 3.17 units on a scale | Standard Deviation 1.4 |
| Placebo | Ankle Pain at 12 Month | Pain Interference (BPI) | 1.0 units on a scale | Standard Deviation 1 |
Secondary
Ankle Pain at 6 Month
Brief pain inventory (BPI) severity subscale measures pain severity with a higher score indicates worse pain (10) and lower score of no pain (0). The pain interference subscale of the BPI measures interference of pain on average of the 7 questions assessing the interference of pain for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Time frame: 6 month follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox | Ankle Pain at 6 Month | Pain Severity (BPI) | 3.38 units on a scale | Standard Deviation 1.9 |
| Botox | Ankle Pain at 6 Month | Pain Interference (BPI) | 3.4 units on a scale | Standard Deviation 2.4 |
| Placebo | Ankle Pain at 6 Month | Pain Severity (BPI) | 2.94 units on a scale | Standard Deviation 1.2 |
| Placebo | Ankle Pain at 6 Month | Pain Interference (BPI) | 1.7 units on a scale | Standard Deviation 2.6 |
Secondary
Functional Status of the Ankle at 12 Month
The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. A higher score represents a higher level of physical function.
Time frame: 12 month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox | Functional Status of the Ankle at 12 Month | 63.1 units on a scale | Standard Deviation 12.5 |
| Placebo | Functional Status of the Ankle at 12 Month | 70.2 units on a scale | Standard Deviation 16.9 |
Secondary
Functional Status of the Ankle at 6 Month
The Foot and Ankle Ability Measure (FAAM) will be obtained to assess the functional status of the affected ankle. Each item is scored on a 5-point Likert scale (4 to 0) from 'no difficulty at all' to 'unable to do'. Item score totals, which range from 0 to 84 for the ADL subscale and 0 to 32 for the Sports subscale, were transformed to percentage scores. Higher scores represent higher levels of function for each subscale, with 100% representing no dysfunction.
Time frame: 6 month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Botox | Functional Status of the Ankle at 6 Month | 32.4 units on a scale | Standard Deviation 19 |
| Placebo | Functional Status of the Ankle at 6 Month | 65.2 units on a scale | Standard Deviation 20.7 |
Secondary
Short Form-36 (SF-36) Health Related Quality of Life
The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best)
Time frame: 12 month follow-up visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox | Short Form-36 (SF-36) Health Related Quality of Life | SF-36 Physical Functioning) | 45.0 units on a scale | Standard Deviation 36.1 |
| Botox | Short Form-36 (SF-36) Health Related Quality of Life | SF-36 Role functioning/physical | 58.3 units on a scale | Standard Deviation 52 |
| Botox | Short Form-36 (SF-36) Health Related Quality of Life | SF-36 General health | 63.3 units on a scale | Standard Deviation 37.5 |
| Placebo | Short Form-36 (SF-36) Health Related Quality of Life | SF-36 Role functioning/physical | 33.3 units on a scale | Standard Deviation 38.2 |
| Placebo | Short Form-36 (SF-36) Health Related Quality of Life | SF-36 Physical Functioning) | 70.0 units on a scale | Standard Deviation 13.2 |
| Placebo | Short Form-36 (SF-36) Health Related Quality of Life | SF-36 General health | 75.0 units on a scale | Standard Deviation 26.5 |
Secondary
Short Form-36 (SF-36)Health Related Quality of Life
The SF-36 is a patient reported survey of health. Physical functioning, role functioning/physical and general health sub-scores ranges from 0 (worst)- 100 (best)
Time frame: 6 month follow-up visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Botox | Short Form-36 (SF-36)Health Related Quality of Life | SF-36 Physical Functioning) | 30.0 units on a scale | Standard Deviation 24.5 |
| Botox | Short Form-36 (SF-36)Health Related Quality of Life | SF-36 Role functioning/physical | 0 units on a scale | Standard Deviation 0 |
| Botox | Short Form-36 (SF-36)Health Related Quality of Life | SF-36 General health | 65.0 units on a scale | Standard Deviation 21.6 |
| Placebo | Short Form-36 (SF-36)Health Related Quality of Life | SF-36 Physical Functioning) | 55.0 units on a scale | Standard Deviation 16.8 |
| Placebo | Short Form-36 (SF-36)Health Related Quality of Life | SF-36 Role functioning/physical | 0 units on a scale | Standard Deviation 0 |
| Placebo | Short Form-36 (SF-36)Health Related Quality of Life | SF-36 General health | 68.8 units on a scale | Standard Deviation 18.9 |