NCT05552235

Brief Summary

Decathlon has developed the Elbow soft300 which is a medical device that must be positioned around the elbow to keep a physical activity on a regular basis in case of chronic epicondylitis, pain associated with tendonitis or chronic instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon Elbow soft 300 product to demonstrate safety and performance of this device in a real-world setting. Outcome data collected from this study will provide the basis for Post-Market Surveillance (PMS) reporting, Clinical Study Report (CSR), Clinical Evaluation Report (CER) on Decathlon ElbowSoft300 device and support peer-reviewed publications on products performance and safety.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

September 13, 2022

Last Update Submit

January 13, 2023

Conditions

EpicondylitisTendonitis ElbowElbow Injury

Outcome Measures

Primary Outcomes (1)

  • Functionnal score

    Comparison of the Patient Rated Elbow Evaluation (20-item questionnaire with a global score from 0=best outcome to 100=worst outcome) between the baseline and last follow-up visit in each group (orthosis vs control)

    Change from Baseline functionnal score at 6 weeks

Secondary Outcomes (4)

  • Confidence level (confidence questionnaire related to physical activity)

    Change from Baseline confidence level at 6 weeks

  • Elbow pain

    Change from Baseline elbow pain at 6 weeks

  • Elbow instability

    Change from Baseline elbow instability at 6 weeks

  • Safety (adverse events)

    6 weeks of follow-up

Study Arms (2)

Orthosis group

EXPERIMENTAL

Use of Elbow Soft 300 device during sport practice

Device: Elbow SOFT 300

Control group

OTHER

No medical device used during sport practice

Other: Control group

Interventions

Elbow SOFT 300DEVICE

15 patients will be included in this group and will used the medical device ElbowSOFT 300 during sport practice (at least 2 sport sessions per week), for 6 weeks.

Orthosis group
Control groupOTHER

15 patients will be included in this control group and will performed their sport sessions as usual (without the medical device), for at least 2 sport sessions per week during 6 weeks.

Control group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject is aged ≥ 18 years old
  • Subject has a chronic epicondylitis (\>3 months) OR elbow pain associated with tendonitis OR chronic elbow instability (\>3 months)
  • The current condition of his/her elbow allows the subject to continue usual physical activity
  • Subject has been informed and is willing to sign an informed consent form
  • Subject is willing to comply with protocol requirements and return to the study center for all clinical evaluations and required follow-up (6 weeks)
  • Subject is affiliated to the French social security regime

You may not qualify if:

  • Subject has conditions that may interfere with his/her ability to understand protocol requirements, participate in scheduled visits, or provide his/her informed consent
  • Subject has worn a support (elbow brace or articulated orthosis) in the last month during his/her sport practice
  • Subject has any medical condition that could impact the study at investigator's discretion
  • Subject has a known hypersensitivity or allergy to the components of the device (polyamide, elastodiene, polyester, elastane)
  • Adult subject to legal protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centre Hospitalier de Boulogne-sur-Mer

Boulogne-sur-Mer, 62200, France

RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Elbow Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Valérie WIECZOREK

    Centre Hospitalier Universitaire de Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean HEE

CONTACT

07 64 35 00 45jean.hee@btwin.com

Sophie TALLON

CONTACT

stallon@soladis.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2022

First Posted

September 23, 2022

Study Start

November 15, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)