Medial Malleolus Fractures
Conditions
Keywords
Medial Malleolus fractures, headless screws, headed screws
Brief summary
The purpose of this study is assess the safety and efficacy of Acutrak headless screws in comparison to other fixation methods (traditional headed screws, plates, and wires) used in the treatment of medial malleolus fracture of the ankle joint. The investigators hope to learn the following objectives from this study 1. Prospectively establish equivalence with respect to fracture union rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 2. Prospectively establish equivalence with respect Patient Reported Outcome Measurement Information System (PROMIS) scores after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 3. Prospectively establish superiority with respect to hardware related pain after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. 4. Prospectively establish superiority with respect to the hardware removal rate after Acutrak headless compression screw fixation when compared to other fixation methods for medial malleolus fractures. Patients scheduled for open reduction and internal fixation for medial malleolus fracture by using Acutrak headless screw or any other method will be asked to enroll by the attending physician, and those patients will be asked to consent to the study. Patients will be randomized by sealed envelope to surgical fixation with traditional headed screws, plates, and wires or Acutrak headless compression screws. At the time of randomization, the fracture pattern and severity, past medical history and medications, and demographic data will be documented. After operative fixation, patients will receive routine fracture follow-up with a clinical evaluation for tenderness, radiographs to evaluate stability and union, and complete the PROMIS and Visual Analogue Pain Scale (VAS) scores to 2 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgical fixation
Interventions
DEVICEFixation by Acutrak headless screw
The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating
DEVICEFixation by headed screws, plates, and or wires
DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ankle fractures that undergo open reduction internal fixation of the medial malleolus
Exclusion criteria
* Tibial plafond (pilon) fractures * Medial malleolar osteotomies to access the talus, perform an ankle fusion, or deal with a pathologic lesion, osteonecrosis, or infection due to their diversity in diagnosis, management, and weight bearing status * Patients with prior surgical treatment of the ankle for fracture, deformity, infection, neoplasia, or other pathologic process on the ipsilateral extremity * Patients that are non-weight bearing on one or both lower extremities prior to sustaining their ankle injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture. | Baseline, year 1 | Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS) | Baseline, year 2 | The PROMIS LEFS scale consists of 20 questions, each on a 5-point Likert scale (0 = extreme difficulty, 4 = no difficulty). Questions are summed for a total score. |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression | Baseline, year 2 | The PROMIS depression score is based on an adaptive test, and reported as a cumulative T-score with standard error. |
| Fracture Union Rate at One Year After Sustaining an Ankle Fracture. | Month 3 | Fracture union rate assessed by radiographic imaging. |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function | Baseline, year 2 | The PROMIS physical function score is based on an adaptive test, and reported as a cumulative T-score with standard error. |
| Amount Pain Medication Required During Recovery Period | Up to 2 years | Pain medication measured in morphine equivalents. |
| Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference | Baseline, year 2 | The PROMIS pain interference score is based on an adaptive test, and reported as a cumulative T-score with standard error. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acutrak Fixation Fixation by Acutrak headless screw: The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating | 0 |
| Standard of Care Fixation Fixation by headed screws, plates, and or wires: DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Standard of Care Fixation | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 |
| other Total, other adverse events | 0 / 0 | 0 / 1 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 |
Outcome results
Primary
Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.
Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).
Time frame: Baseline, year 1
Population: No analysis was conducted due to small sample size and confidentiality concerns.
Secondary
Amount Pain Medication Required During Recovery Period
Pain medication measured in morphine equivalents.
Time frame: Up to 2 years
Population: No analysis was conducted due to small sample size and confidentiality concerns.
Secondary
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression
The PROMIS depression score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Time frame: Baseline, year 2
Population: No analysis was conducted due to small sample size and confidentiality concerns.
Secondary
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS)
The PROMIS LEFS scale consists of 20 questions, each on a 5-point Likert scale (0 = extreme difficulty, 4 = no difficulty). Questions are summed for a total score.
Time frame: Baseline, year 2
Population: No analysis was conducted due to small sample size and confidentiality concerns.
Secondary
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference
The PROMIS pain interference score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Time frame: Baseline, year 2
Population: No analysis was conducted due to small sample size and confidentiality concerns.
Secondary
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function
The PROMIS physical function score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Time frame: Baseline, year 2
Population: No analysis was conducted due to small sample size and confidentiality concerns.
Secondary
Fracture Union Rate at One Year After Sustaining an Ankle Fracture.
Fracture union rate assessed by radiographic imaging.
Time frame: Month 3
Population: No analysis was conducted due to small sample size and confidentiality concerns.