Completed

NCT Number: NCT04120662

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

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.

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Key information

Conditions

Stress Fracture Metatarsal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion Garcia Cugat

Barcelona, 08023, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intramedullary screw fixation

Procedure

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.

Focused Shock Wave Treatment

Device

3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.

Primary outcomes

Evaluation of X-Ray

Time frame: Follow up until recovery (maximum of 6 months)

X-Ray study
Period until return to play

Time frame: Follow up until recovery (maximum of 6 months)

When the patient can start the previous to injury activity

Secondary outcomes

Evaluation of Visual Analogue Scale

Time frame: Follow up until recovery (maximum of 6 months)

Subjective evaluation of the pain intensity from 0 (non-existent paint) to 10 (maximum pain feeling)
American Orthopedic Foot and Ankle Score

Time frame: Follow up until recovery (maximum of 6 months)

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

Time frame: Follow up until recovery (maximum of 6 months)

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.

Sponsors and collaborators

Lead sponsor

Fundación Garcia Cugat

Other

Registry information

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Oct 9, 2019
Registry last updated: Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.