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

NCT04120662 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-07-21

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fundación Garcia Cugat

    lead OTHER

Principal Investigators

  • Montse Garcia · Fundación Garcia Cugat

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-26
Primary Completion
2019-08-01
Completion
2019-10-15

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120662 on ClinicalTrials.gov