NCT04653753

Brief Summary

Decathlon has developed kneeSOFT500 product, which is a medical device intended to be used on the knee to keep a physical activity on a regular basis in case of patellofemoral pain syndrome or patellar instability. The objective of this multicentre study is to collect data on the related clinical complications and clinical outcomes of market-approved Decathlon kneeSOFT500 product to demonstrate safety and performance of this device in a real-world setting.

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 Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 2, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

2.2 years

First QC Date

September 4, 2020

Last Update Submit

September 12, 2022

Conditions

Patellofemoral Pain SyndromePatellar Instability

Outcome Measures

Primary Outcomes (1)

  • Functional score

    Comparison of the functional result (Kujala Anterior Knee Pain Scale, 0-100 points) between the baseline and last follow-up visit in each group (orthosis vs control)

    18 weeks of follow-up

Secondary Outcomes (4)

  • Confidence level

    At baseline and 18 weeks of follow-up

  • Knee instability

    At 6 weeks, 12 weeks and 18 weeks of follow-up

  • Knee pain

    At 6 weeks, 12 weeks and 18 weeks of follow-up

  • Safety (adverse events)

    18 weeks of follow-up

Study Arms (2)

Orthosis Group

EXPERIMENTAL

Use of kneeSOFT500 device

Device: kneeSOFT500

Control Group

NO INTERVENTION

No use of the device

Interventions

kneeSOFT500DEVICE

At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use a knee support device.

Orthosis Group

Eligibility Criteria

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

You may qualify if:

  • Subject is aged ≥18 years old
  • Subject has patellofemoral syndrome
  • The current condition of his/her knee allows the subject to keep a regular 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 (18 weeks)
  • Subject is affiliated to the French social security regime
  • 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 (knee 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, cotton, elastane, elastodiene, polyester)
  • Adult subject to a legal protection measure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Centre de rééducation et de balnéothérapie Kinés Faches

Faches-Thumesnil, 59155, France

RECRUITING

Physio Sport Levallois

Levallois-Perret, 92300, France

RECRUITING

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

RECRUITING

Cabinet de kinésithérapie du Belvédère

Paris, 75019, France

NOT YET RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Valérie WIECZOREK

    Centre Hospitalier Universitaire de Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean HEE

CONTACT

XX XX XX XX XXjean.hee@btwin.com

Study Design

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

Study Record Dates

First Submitted

September 4, 2020

First Posted

December 4, 2020

Study Start

March 2, 2021

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)