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Orthotics

Knee Brace Fastening Systems for Knee Osteoarthritis

N/A
Recruiting
Research Sponsored by TOPMED
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between after 2 weeks adjustment period and after 2 weeks of use for each arm
Awards & highlights
No Placebo-Only Group

Summary

This trial tests how two different fastening systems for knee braces can affect comfort, ease of use, and treatment outcomes.

Who is the study for?
This trial is for individuals who have been using an ODRA knee brace for several hours daily over the past 6 months. It's aimed at those with osteoarthritis seeking better comfort and treatment outcomes from their braces. People with wounds on their lower body cannot participate.
What is being tested?
The study is examining two different types of fastening systems for knee braces: one uses velcro straps, while the other employs a cable fastening mechanism. The goal is to compare how each system affects comfort, ease of use, and overall effectiveness in treating osteoarthritis symptoms.
What are the potential side effects?
While not typical side effects as seen with medications, participants may experience discomfort or skin irritation from the different strap systems being tested. Psychological impacts due to ease of use or efficacy perceptions are also considered.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between after 2 weeks adjustment period and after 2 weeks of use for each arm
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between after 2 weeks adjustment period and after 2 weeks of use for each arm for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Comfort
Physical symptoms
Psychological symptoms
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Cable fastening systemExperimental Treatment1 Intervention
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Group II: Velcro strapsActive Control1 Intervention
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.

Find a Location

Who is running the clinical trial?

Conseil de recherches en sciences naturelles et en génie du CanadaUNKNOWN
2 Previous Clinical Trials
98 Total Patients Enrolled
TOPMEDLead Sponsor
9 Previous Clinical Trials
598 Total Patients Enrolled
Laboratoires VicthomUNKNOWN

Media Library

Cable fastening system and 3d printed straps (Orthotics) Clinical Trial Eligibility Overview. Trial Name: NCT05814471 — N/A
Knee osteoarthritis Research Study Groups: Velcro straps, Cable fastening system
Knee osteoarthritis Clinical Trial 2023: Cable fastening system and 3d printed straps Highlights & Side Effects. Trial Name: NCT05814471 — N/A
Cable fastening system and 3d printed straps (Orthotics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05814471 — N/A
~4 spots leftby Nov 2025
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