Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
Primary Purpose
Stress Fracture Metatarsal
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Intramedullary screw fixation
Focused Shock Wave Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stress Fracture Metatarsal
Eligibility Criteria
Inclusion Criteria:
- Male soccer players, aged over 18 years.
- Diagnosis of proximal fifth metatarsal stress fracture, according to clinical signs and symptoms and to radiologic findings
- Fracture occurred during soccer practice
- Informed consent signed
Exclusion Criteria:
- To be under 18 years old
- Traumatic fracture
- Fracture occurred out of soccer practice
- Patients with metatarsal shaft, neck or head fracture
- Patients with contraindication to receive surgical treatment
- Patients with contraindication to receive shock wave treatment
- Patients that refuse the informed consent
Sites / Locations
- Fundacion Garcia Cugat
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A: Surgery group
Goup B: Shockwave group
Arm Description
Surgical procedure according to the injury type
3 weekly sessions of Focused Shock Wave Treatment (F-ESWT), using an electrohydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses
Outcomes
Primary Outcome Measures
Evaluation of X-Ray
X-Ray study
Period until return to play
When the patient can start the previous to injury activity
Secondary Outcome Measures
Evaluation of Visual Analogue Scale
Subjective evaluation of the pain intensity from 0 (non-existent paint) to 10 (maximum pain feeling)
American Orthopedic Foot and Ankle Score
Measures the results of the treatment for complex foot and ankle injuries that combines a patient informed and a specialist informed report. Scores range from 0 to 100, with a healthy midfoot receiving 100 point.
Evaluation of Tegner activity scale
Tegner activity scale grades the daily life activities and recreational and professional sports practice. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6 score can only be achieved if the person participates in recreational or competitive sport.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04120662
Brief Title
Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
Official Title
Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Garcia Cugat
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Fifth metatarsal stress fracture is a failure of a healthy metatarsal bone subject to repetitive microdamages. It has a high prevalence in soccer players and is classified as a high-risk stress fracture. Based on Torg classification, the treatment options may be conservative or surgical. The recent increase of evidences about Shock Wave Treatment in different bone pathologies, including stress fractures, suggests the possibility to use this conservative intervention option also in patients candidate for surgery. This randomized clinical trial included 18 soccer players diagnosed of proximal fifth metatarsal stress fracture, randomly matched in Surgery group and Shock Wave group. Patients of Surgery group were treated with intramedullary screw fixation; patients of Shock Wave group received 3 weekly sessions of Focused Shock Wave Treatment (F-ESWT), using an electrohydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses. Patients of both groups were followed monthly until their return to play (RTP) using radiography, Visual Analogue Scale (VAS), Tegner Activity Level Scale and AOFAS score.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Fracture Metatarsal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: Surgery group
Arm Type
Active Comparator
Arm Description
Surgical procedure according to the injury type
Arm Title
Goup B: Shockwave group
Arm Type
Active Comparator
Arm Description
3 weekly sessions of Focused Shock Wave Treatment (F-ESWT), using an electrohydraulic device set to an energy flux density (EFD) of 0.21 mJ/mm2 and 2000 impulses
Intervention Type
Procedure
Intervention Name(s)
Intramedullary screw fixation
Intervention Description
A Kirschner wire was introduced in the proximal tuberosity under anteroposterior and lateral fluoroscopic control, following the bone axis and passing through the fracture line; a cannulated compressor screw in a diameter between 45 - 55 mm in the more satisfactory position to achieve the optimal fragments compression.
Intervention Type
Device
Intervention Name(s)
Focused Shock Wave Treatment
Intervention Description
3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.
Primary Outcome Measure Information:
Title
Evaluation of X-Ray
Description
X-Ray study
Time Frame
Follow up until recovery (maximum of 6 months)
Title
Period until return to play
Description
When the patient can start the previous to injury activity
Time Frame
Follow up until recovery (maximum of 6 months)
Secondary Outcome Measure Information:
Title
Evaluation of Visual Analogue Scale
Description
Subjective evaluation of the pain intensity from 0 (non-existent paint) to 10 (maximum pain feeling)
Time Frame
Follow up until recovery (maximum of 6 months)
Title
American Orthopedic Foot and Ankle Score
Description
Measures the results of the treatment for complex foot and ankle injuries that combines a patient informed and a specialist informed report. Scores range from 0 to 100, with a healthy midfoot receiving 100 point.
Time Frame
Follow up until recovery (maximum of 6 months)
Title
Evaluation of Tegner activity scale
Description
Tegner activity scale grades the daily life activities and recreational and professional sports practice. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports >6 score can only be achieved if the person participates in recreational or competitive sport.
Time Frame
Follow up until recovery (maximum of 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male soccer players, aged over 18 years.
Diagnosis of proximal fifth metatarsal stress fracture, according to clinical signs and symptoms and to radiologic findings
Fracture occurred during soccer practice
Informed consent signed
Exclusion Criteria:
To be under 18 years old
Traumatic fracture
Fracture occurred out of soccer practice
Patients with metatarsal shaft, neck or head fracture
Patients with contraindication to receive surgical treatment
Patients with contraindication to receive shock wave treatment
Patients that refuse the informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Montse Garcia
Organizational Affiliation
Fundación Garcia Cugat
Official's Role
Study Chair
Facility Information:
Facility Name
Fundacion Garcia Cugat
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
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