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

September 25, 2020 updated by: Derek Amanatullah, Stanford University

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94063
        • Stanford University School of Medicine
      • Sacramento, California, United States, 95823
        • Kaiser Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fixation by Acutrak headless screw
Device: 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
Other Names:
  • Acutrak 2 Headless Compression Screw System
Active Comparator: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Severity of Hardware Related Pain Localized to the Medial Malleolus at One Year After Sustaining an Ankle Fracture.
Time Frame: Baseline, year 1
Pain on a visual analogue scale (range: 0 to 1; 0 = no pain; 10 = worst pain imaginable).
Baseline, year 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fracture Union Rate at One Year After Sustaining an Ankle Fracture.
Time Frame: Month 3
Fracture union rate assessed by radiographic imaging.
Month 3
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Lower Extremity Function Scale (LEFS)
Time Frame: Baseline, year 2
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
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression
Time Frame: Baseline, year 2
The PROMIS depression score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Baseline, year 2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Pain Interference
Time Frame: Baseline, year 2
The PROMIS pain interference score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Baseline, year 2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Physical Function
Time Frame: Baseline, year 2
The PROMIS physical function score is based on an adaptive test, and reported as a cumulative T-score with standard error.
Baseline, year 2
Amount Pain Medication Required During Recovery Period
Time Frame: Up to 2 years
Pain medication measured in morphine equivalents.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Study Director: Derek Amanatullah, MD, Stanford University School of Medicine, CA
  • Principal Investigator: Micheal Weaver, MD, Brigham and Women's Hospital, Harvard Medical School, Boston, MA
  • Principal Investigator: Domingo Hallare, MD, Kaiser Permanente Hospital, South Sacramento, CA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2017

Primary Completion (Actual)

October 26, 2017

Study Completion (Actual)

October 26, 2017

Study Registration Dates

First Submitted

February 11, 2017

First Submitted That Met QC Criteria

February 17, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

October 22, 2020

Last Update Submitted That Met QC Criteria

September 25, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 37630

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Medial Malleolus Fractures

Clinical Trials on Fixation by Acutrak headless screw

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe