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

NCT04120662 | Completed DMC

• 1 other identifier: REHA-2019-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Fracture Metatarsal

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• 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)

Study Arms (2)

Group A: Surgery group

ACTIVE COMPARATOR

Surgical procedure according to the injury type

Procedure: Intramedullary screw fixation

Goup B: Shockwave group

ACTIVE COMPARATOR

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

Device: Focused Shock Wave Treatment

Interventions

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.

Group A: Surgery group

Focused Shock Wave Treatment DEVICE

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

Goup B: Shockwave group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Garcia Cugat: lead

Study Sites (1)

Fundacion Garcia Cugat

Barcelona, 08023, Spain

Location

Study Officials

• Montse Garcia

  Fundación Garcia Cugat

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: October 9, 2019
• Study Start: February 26, 2019
• Primary Completion: August 1, 2019
• Study Completion: October 15, 2019
• Last Updated: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)