Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05814471
Status:
RECRUITING
Last Update Posted:
2024-05-06
First Post:
2023-03-16
Brief Title:
Validation orthèse Pour Gonarthrose
Sponsor:
TOPMED
Organization:
TOPMED
Study Overview
Official Title:
Protocole de Validation dUne orthèse de Genou Valgisante Pour Gonarthrose
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A study about the effects of different fastening systems for knee braces on comfort ease of installation and treatment efficacy both physical and psychological Two different systems will be tested velcro straps and a cable-fastening system
Detailed Description:
There are 2 main types of knee braces for gonarthrosis soft knee braces and rigid knee braces Soft knee braces use malleable materials such as cloth or rubber to apply forces on the leg whereas rigid braces use plastic or metal shells Three main types of fastening systems are used on these types of orthoses velcro systems hybrid systems and cable fastening systems Therefore different configurations exist to reduce biomechanical deficits caused by the pathology
Each fastening system has its advantages and disadvantages Velcro straps are fast and intuitive to use altough multiple difficulties are mentionned adjusment cleaning the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps Hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process Cable fastening systems also use quick-release fasteners The adjusment process is simple and precise with minimal noise with these systems
Comfort efficacy and ease of use are essential qualities of a knee brace Confort is primordial as it is directly linked to treatment adherence by the patients Efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient Ease of use must be optimized as it presents an opportunity to increase treatment adherence The goal of the fastening system developped in partnership with Laboratoires Victhom is the increase the ease of use of the knee brace while maintaining comfort and treatment efficacy
Each fastening system has its advantages and disadvantages Velcro straps are fast and intuitive to use altough multiple difficulties are mentionned adjusment cleaning the number of straps needed to maintain the knee brace in position as well as the noise while detaching the straps Hybrid systems regularly use velcro straps to which are added quick-release fasteners to simplify the installation and uninstallation process Cable fastening systems also use quick-release fasteners The adjusment process is simple and precise with minimal noise with these systems
Comfort efficacy and ease of use are essential qualities of a knee brace Confort is primordial as it is directly linked to treatment adherence by the patients Efficacy of a knee brace treatment may be measured by symptom or medication use evolution but also with daily practice of problematic movement by the patient Ease of use must be optimized as it presents an opportunity to increase treatment adherence The goal of the fastening system developped in partnership with Laboratoires Victhom is the increase the ease of use of the knee brace while maintaining comfort and treatment efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None