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

Not Applicable

Terminated

• Conditions: Medial Malleolus Fractures
• Interventions: Device: Fixation by Acutrak headless screw; Device: Fixation by headed screws, plates, and or wires

• Registration Number: NCT03061279
• Lead Sponsor: Stanford University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-11
• Study First Submitted QC: 2017-02-17
• Study First Posted: 2017-02-23
• Study Start: 2017-04-01
• Primary Completion: 2017-10-26
• Study Completion: 2017-10-26
• Results First Submitted: 2020-02-16
• Results First Submitted QC: 2020-02-16
• Results First Posted: 2020-03-02
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-25
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixation by Acutrak headless screw	Fixation by Acutrak headless screw	-
Fixation by headed screws, plates and or 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 LC-DCP Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Fracture Union Rate at One Year After Sustaining an Ankle Fracture.	Month 3	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)	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.
Change in Patient Reported Outcome Measurement Information System (PROMIS) Scores at Two Years After Sustaining an Ankle Fracture - Depression	Baseline, year 2	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	Baseline, year 2	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	Baseline, year 2	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	Up to 2 years	Pain medication measured in morphine equivalents.

Trial Locations

Locations (3)

Brigham and Women's Hospital,; 🇺🇸 Boston, Massachusetts, United States

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

Kaiser Hospital; 🇺🇸 Sacramento, California, United States