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Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures

Primary Purpose

Medial Malleolus Fractures

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fixation by Acutrak headless screw
Fixation by headed screws, plates, and or wires
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medial Malleolus Fractures focused on measuring Medial Malleolus fractures, headless screws, headed screws

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine
  • Kaiser Hospital
  • Brigham and Women's Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fixation by Acutrak headless screw

Fixation by headed screws, plates and or wire

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Fracture Union Rate at One Year After Sustaining an Ankle Fracture.
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 - 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.
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.
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.
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.
Amount Pain Medication Required During Recovery Period
Pain medication measured in morphine equivalents.

Full Information

First Posted
February 11, 2017
Last Updated
September 25, 2020
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT03061279
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Problem negotiating other sites
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
October 26, 2017 (Actual)
Study Completion Date
October 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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 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. 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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medial Malleolus Fractures
Keywords
Medial Malleolus fractures, headless screws, headed screws

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fixation by Acutrak headless screw
Arm Type
Experimental
Arm Title
Fixation by headed screws, plates and or wire
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fixation by Acutrak headless screw
Other Intervention Name(s)
Acutrak 2 Headless Compression Screw System
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Fixation by headed screws, plates, and or wires
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.
Description
Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).
Time Frame
Baseline, year 1
Secondary Outcome Measure Information:
Title
Fracture Union Rate at One Year After Sustaining an Ankle Fracture.
Description
Fracture union rate assessed by radiographic imaging.
Time Frame
Month 3
Title
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS)
Description
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
Title
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression
Description
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
Title
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference
Description
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
Title
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function
Description
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
Title
Amount Pain Medication Required During Recovery Period
Description
Pain medication measured in morphine equivalents.
Time Frame
Up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derek Amanatullah, MD
Organizational Affiliation
Stanford University School of Medicine, CA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Micheal Weaver, MD
Organizational Affiliation
Brigham and Women's Hospital, Harvard Medical School, Boston, MA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Domingo Hallare, MD
Organizational Affiliation
Kaiser Permanente Hospital, South Sacramento, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Kaiser Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Brigham and Women's Hospital,
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11001416
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.
Results Reference
background
PubMed Identifier
7820240
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.
Results Reference
background
PubMed Identifier
22491610
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.
Results Reference
background
PubMed Identifier
21117562
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.
Results Reference
background
PubMed Identifier
17106379
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.
Results Reference
background
PubMed Identifier
22491565
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.
Results Reference
background
PubMed Identifier
11371792
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.
Results Reference
background
PubMed Identifier
23749433
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.
Results Reference
background

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Clinical Trial Evaluating Acutrak Headless Compression Screw Fixation of Medial Malleolus Fractures

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