Medial Malleolus Fractures Clinical Trial
Official title:
Randomized Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
| NCT number | NCT03061279 |
| Other study ID # | 37630 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 1, 2017 |
| Est. completion date | October 26, 2017 |
| Verified date | September 2020 |
| Source | Stanford University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | October 26, 2017 |
| Est. primary completion date | October 26, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Brigham and Women's Hospital, | Boston | Massachusetts |
| United States | Stanford University School of Medicine | Palo Alto | California |
| United States | Kaiser Hospital | Sacramento | California |
| Lead Sponsor | Collaborator |
|---|---|
| Stanford University |
United States,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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). | Baseline, year 1 | |
| Secondary | Fracture Union Rate at One Year After Sustaining an Ankle Fracture. | Fracture union rate assessed by radiographic imaging. | Month 3 | |
| 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. | Baseline, year 2 | |
| 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. | Baseline, year 2 | |
| 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. | Baseline, year 2 | |
| 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. | Baseline, year 2 | |
| Secondary | Amount Pain Medication Required During Recovery Period | Pain medication measured in morphine equivalents. | Up to 2 years |