Knee Braces for Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores two types of knee braces to assess their effectiveness for individuals with knee osteoarthritis, particularly in the inner knee. It compares the ROAM OA Single Upright Brace with the Ossur Unloader One Knee Brace to evaluate their impact on walking and pain levels. The study also aims to determine if the ROAM OA brace can improve pain and movement over an extended period. Suitable participants have been diagnosed with medial knee osteoarthritis, experience significant walking pain, and can walk independently for 20 minutes. As an unphased trial, this study provides a unique opportunity to enhance understanding of how different knee braces can improve quality of life for those with knee osteoarthritis.
Do I have to stop taking my current medications for the trial?
The trial requires that your pain medication regimen has been stable for at least 4 weeks, so you should not change your current medications if you want to participate.
What prior data suggests that these knee braces are safe for individuals with osteoarthritis?
Research has shown that knee braces like the Ossur Unloader One and the ROAM OA Single Upright Knee Brace are generally safe for people with knee osteoarthritis. These braces reduce pressure on the knee joint and improve movement. Studies have found that these braces often enhance daily activities, lessen pain, and improve mobility without major safety issues.
The Ossur Unloader One is a popular choice for managing knee osteoarthritis. It shifts weight away from the painful part of the knee, reducing pain during movement.
The ROAM OA Single Upright Knee Brace is a newer option that also reduces pressure and improves knee function. While specific safety data for the ROAM OA brace is not detailed, its design suggests it is likely well-tolerated, similar to other braces.
Overall, both braces are non-invasive and generally considered safe, with most users not experiencing significant side effects.12345Why are researchers excited about this trial?
Researchers are excited about the ROAM OA Single Upright Knee Brace because it specifically targets the medial compartment of the knee, which is a common source of pain in osteoarthritis. Unlike standard treatments such as medications or general physical therapy, this brace is engineered to offload pressure from the knee, potentially improving both pain and function. Meanwhile, the Ossur Unloader One knee brace, serving as an active comparator, is also designed to reduce knee pain but offers a different approach by distributing weight away from the affected area. Both braces aim to enhance mobility and quality of life, standing out from typical pain management strategies by focusing on mechanical alignment and support.
What evidence suggests that these knee braces are effective for osteoarthritis?
Studies have shown that knee braces can reduce pain and improve movement for people with knee osteoarthritis. In this trial, participants will receive either the ROAM OA Single Upright Knee Brace or the Ossur Unloader One Knee Brace. The ROAM OA Single Upright Knee Brace takes pressure off the inner part of the knee, shifting weight away from the painful area. Research indicates that this can lead to less pain and better movement in daily activities. Similarly, the Ossur Unloader One Knee Brace improves mobility by easing pressure on the knee. Both braces aim to make walking and other activities less painful for people with knee osteoarthritis.12367
Are You a Good Fit for This Trial?
This trial is for individuals with medial compartment osteoarthritis, a type of knee arthritis. Participants should be seeking treatment options and willing to wear a knee brace as part of the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline data collection, including gait analysis and pain assessment, before brace fitting
Treatment
Participants receive either the ROAM OA brace or the Ossur Unloader One brace and undergo gait analysis and pain assessment
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of pain and functional outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Ossur Unloader One Knee Brace
- ROAM OA Single Upright Knee Brace
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rush University Medical Center
Lead Sponsor
Enovis
Collaborator