NCT04120662|CompletedDMC
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Sponsor study identifier
interventional
30
1 country
1
Study Start
February 26, 2019
Actual (reported)Primary Completion
August 1, 2019
Actual (reported)Study Completion
October 15, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 15, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 26, 2019
Actual (reported)July 25, 2019
Actual (reported)August 1, 2019
Actual (reported)October 9, 2019
Actual (reported)October 15, 2019
Actual (reported)Evaluation of X-Ray
X-Ray study
Follow up until recovery (maximum of 6 months)
Period until return to play
When the patient can start the previous to injury activity
Follow up until recovery (maximum of 6 months)
Evaluation of Visual Analogue Scale
Follow up until recovery (maximum of 6 months)
American Orthopedic Foot and Ankle Score
Follow up until recovery (maximum of 6 months)
Evaluation of Tegner activity scale
Follow up until recovery (maximum of 6 months)
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
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.
3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.
Fundacion Garcia Cugat
Barcelona, 08023, Spain
Montse Garcia
Fundación Garcia Cugat
30 participants (actual enrollment reported by the registry).
First Submitted
July 25, 2019
First Posted
October 9, 2019
Study Start
February 26, 2019
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 1, 2019
Actual (reported)Study Completion
October 15, 2019
Actual (reported)Last Updated
July 21, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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