Clinical trial NCT03061279: Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
Official title: Randomized Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Medial Malleolus Fractures
Keywords: Medial Malleolus fractures
headless screws
headed screws
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.
timeFrame: Baseline, year 1
Secondary outcomes:
measure: Fracture Union Rate at One Year After Sustaining an Ankle Fracture.
timeFrame: Month 3
measure: Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS)
timeFrame: Baseline, year 2
measure: Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression
timeFrame: Baseline, year 2
measure: Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference
timeFrame: Baseline, year 2
measure: Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function
timeFrame: Baseline, year 2
measure: Amount Pain Medication Required During Recovery Period
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
city: Sacramento
country: United States
facility: Kaiser Hospital
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital,
state: Massachusetts
Study officials:
affiliation: Stanford University School of Medicine, CA
name: Derek Amanatullah, MD
role: STUDY_DIRECTOR
affiliation: Brigham and Women's Hospital, Harvard Medical School, Boston, MA
name: Micheal Weaver, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kaiser Permanente Hospital, South Sacramento, CA
name: Domingo Hallare, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.