Stress Fracture MetatarsalNCT04120662
Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
A study testing Intramedullary screw fixation and Focused Shock Wave Treatment in people with Stress Fracture Metatarsal, run by Fundación Garcia Cugat at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress Fracture Metatarsal
- What is being tested?
- Intramedullary screw fixation and Focused Shock Wave Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 26 Feb 2019to 15 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Intramedullary screw fixation, Focused Shock Wave Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramedullary screw fixationProcedure or surgery
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 TreatmentDevice
3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Surgery group | Active comparator | Surgical procedure according to the injury type Receives: 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 Receives: Device: Focused Shock Wave Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of X-Ray
X-Ray study
Measured: Follow up until recovery (maximum of 6 months)
Period until return to play
When the patient can start the previous to injury activity
Measured: Follow up until recovery (maximum of 6 months)
Secondary outcomes (3)
Evaluation of Visual Analogue Scale
Subjective evaluation of the pain intensity from 0 (non-existent paint) to 10 (maximum pain feeling)
Measured: Follow up until recovery (maximum of 6 months)
American Orthopedic Foot and Ankle Score
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.
Measured: Follow up until recovery (maximum of 6 months)
Evaluation of Tegner activity scale
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.
Measured: Follow up until recovery (maximum of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start26 Feb 2019
- Primary completion1 Aug 2019
- Study completion15 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Fracture MetatarsalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Garcia Cugat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Montse Garcia, Study chair, Fundación Garcia Cugat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120662
- Sponsor's protocol ID
- REHA-2019-02
- Status last verified
- Jul 2021
- First submitted
- 25 Jul 2019
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Shockwave Treatment for Proximal Fifth Metatarsal Stress Fracture in Soccer Players
- ClinicalTrials.gov ID
- NCT04120662
- Acronym / sponsor ID
- REHA-2019-02
- Conditions
- Stress Fracture Metatarsal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Fundación Garcia CugatUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 15 Oct 2019 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Surgery group | Active comparator | Procedure: Intramedullary screw fixationSurgical procedure according to the injury type |
| Goup B: Shockwave group | Active comparator | Device: Focused Shock Wave Treatment3 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramedullary screw fixationA 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. | Procedure or surgery | Group A: Surgery group |
| Focused Shock Wave Treatment3 weekly session, one per week, of focused shock waves, using an electrohydraulic device. | Device | Goup B: Shockwave group |
Primary outcome
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
3 secondary outcomes
Evaluation of Visual Analogue Scale
Time frame: Follow up until recovery (maximum of 6 months)
American Orthopedic Foot and Ankle Score
Time frame: Follow up until recovery (maximum of 6 months)
Evaluation of Tegner activity scale
Time frame: Follow up until recovery (maximum of 6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Stress Fracture Metatarsal
Recruiting
Treatment of Fifth Metatarsal Zone 3 Fractures
Fractures, Stress, Metatarsal Fracture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montse Garcia study chair
Fundación Garcia Cugat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intramedullary screw fixation and Focused Shock Wave Treatment in people with Stress Fracture Metatarsal, run by Fundación Garcia Cugat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of X-Ray (time frame: Follow up until recovery (maximum of 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.