Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
NCT ID: NCT03061279
Last Updated: 2020-10-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
1 participants
INTERVENTIONAL
2017-04-01
2017-10-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle Fractures
NCT00718302
Tension Band Wiring Versus Cannulated Screws in Fixation of Medial Malleolus in Ankle Fracture
NCT04301037
Fixation of the Posterior Malleolus in Medium-sized Trimalleolar AO Weber-B Fractures.
NCT02596529
Medial Malleolus: Operative Or Non-operative
NCT03362229
Intramedullary Fixation for Metacarpal Fractures: A Prospective Study Comparing Outcomes
NCT06631924
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fixation by Acutrak headless screw
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
Fixation by headed screws, plates and or wire
DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes LC-DCP Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stanford University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Derek Amanatullah
Assistant Professor, Dept of Orthopedic Surgery
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Derek Amanatullah, MD
Role: STUDY_DIRECTOR
Stanford University School of Medicine, CA
Micheal Weaver, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Domingo Hallare, MD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente Hospital, South Sacramento, CA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University School of Medicine
Palo Alto, California, United States
Kaiser Hospital
Sacramento, California, United States
Brigham and Women's Hospital,
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Rovinsky D, Haskell A, Liu Q, Paiement GD, Robinovitch S. Evaluation of a new method of small fragment fixation in a medial malleolus fracture model. J Orthop Trauma. 2000 Aug;14(6):420-5. doi: 10.1097/00005131-200008000-00007.
Toolan BC, Koval KJ, Kummer FJ, Sanders R, Zuckerman JD. Vertical shear fractures of the medial malleolus: a biomechanical study of five internal fixation techniques. Foot Ankle Int. 1994 Sep;15(9):483-9. doi: 10.1177/107110079401500905.
Amanatullah DF, McDonald E, Shellito A, Lafazan S, Cortes A, Curtiss S, Wolinsky PR. Effect of mini-fragment fixation on the stabilization of medial malleolus fractures. J Trauma Acute Care Surg. 2012 Apr;72(4):948-53. doi: 10.1097/TA.0b013e318249697d.
Amanatullah DF, Wolinsky PR. An alternative fixation technique for small medial malleolus fractures. Orthopedics. 2010 Dec;33(12):888. doi: 10.3928/01477447-20101021-17. No abstract available.
Dumigan RM, Bronson DG, Early JS. Analysis of fixation methods for vertical shear fractures of the medial malleolus. J Orthop Trauma. 2006 Nov-Dec;20(10):687-91. doi: 10.1097/01.bot.0000247075.17548.3a.
Amanatullah DF, Khan SN, Curtiss S, Wolinsky PR. Effect of divergent screw fixation in vertical medial malleolus fractures. J Trauma Acute Care Surg. 2012 Mar;72(3):751-4. doi: 10.1097/TA.0b013e31823b8b9f.
Brown OL, Dirschl DR, Obremskey WT. Incidence of hardware-related pain and its effect on functional outcomes after open reduction and internal fixation of ankle fractures. J Orthop Trauma. 2001 May;15(4):271-4. doi: 10.1097/00005131-200105000-00006.
Hung M, Baumhauer JF, Latt LD, Saltzman CL, SooHoo NF, Hunt KJ; National Orthopaedic Foot & Ankle Outcomes Research Network. Validation of PROMIS (R) Physical Function computerized adaptive tests for orthopaedic foot and ankle outcome research. Clin Orthop Relat Res. 2013 Nov;471(11):3466-74. doi: 10.1007/s11999-013-3097-1.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
37630
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.