Equinus Contracture Clinical Trial
— BotoxOfficial title:
The Effect of Botulinum Toxin A Injections on Ankle Dorsiflexion Following Internal Fixation of Tibial Plafond (Pilon) Fractures: A Pilot Study
| NCT number | NCT02051933 |
| Other study ID # | 03-12-19B |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | January 2013 |
| Est. completion date | May 2016 |
| Verified date | February 2022 |
| Source | Wake Forest University Health Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 10 |
| Est. completion date | May 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Carolinas Medical Center | Charlotte | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Wake Forest University Health Sciences |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 6 month follow-up visit | |
| 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) | 6 month follow-up visit | |
| 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) | 12 month follow-up visits | |
| 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. | 6 month follow-up visit | |
| 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. | 12 month follow-up visit | |
| 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. |
6 month follow-up visit | |
| 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. | 12 month follow-up visit |