NCT04120662

Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fundación Garcia Cugat · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stress Fracture Metatarsal

Interventions

Type	Name	Description
PROCEDURE	Intramedullary screw fixation	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.
DEVICE	Focused Shock Wave Treatment	3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.

Timeline

• Start date: 2019-02-26
• Primary completion: 2019-08-01
• Completion: 2019-10-15
• First posted: 2019-10-09
• Last updated: 2021-07-21

Locations

1 site across 1 country: Spain