Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/25/2017 |
| Start Date: | April 1, 2017 |
| End Date: | March 1, 2021 |
| Contact: | Prerna Arora, M.Tech |
| Email: | arprerna@stanford.edu |
| Phone: | 650-721-7631 |
Randomized Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
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
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
Inclusion Criteria:
1. All ankle fractures that undergo open reduction internal fixation of the medial
malleolus in adults at or over 18 years-of-age will be considered for inclusion.
Exclusion Criteria:
1. All pediatric ankle fractures in children under 18 years-of-age
2. Tibial plafond (pilon) fractures in children and adults
3. 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.
4. Patients with prior surgical treatment of the ankle for fracture, deformity,
infection, neoplasia, or other pathologic process on the ipsilateral extremity will
also be excluded.
5. Patients that are non-weight bearing on one or both lower extremities prior to
sustaining their ankle injury will be excluded.
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