NCT05905809

Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

Controlled, Randomized, Open Label Study to Assess the Efficacy of UniRelieverTM Offloading Brace in the Management of Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Thuasne · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy and performance of a new semi-rigid offloading brace in the management of knee osteoarthritis.

Detailed description

Osteoarthritis (OA) is one of the leading causes of physical disability in the world, affecting a growing portion of the elderly, indeed, it is estimated that 85% of all people over age 60 have some degree of OA. A survey of 2000 French general practitioners indicated that 10% usually prescribe knee orthoses for patients with knee OA. With the increasing importance of non-pharmacological treatment in recommendations for OA, orthoses will increase in use. The use of an offloading knee brace that encompasses the knee has proven to be a safe, cost-efficient treatment option for reducing pain and improving function. It can even delay the need for surgery. The aim of this study is to perform a randomized, prospective, interventional, 3-arm parallel group study to look at the difference in outcome in knee osteoarthritic patient with the use of the new semi-rigid offloading brace versus knee brace comparator versus without orthosis.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	UniRelieverTM offloading brace (THUASNE)	The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it
DEVICE	Unloader One® X brace (Össur)	The patient will be instructed to wear the brace during walking and physical exercise. The investigator will explain to the patient how to adjust it

Timeline

• Start date: 2023-06-07
• Primary completion: 2023-09-20
• Completion: 2023-09-20
• First posted: 2023-06-15
• Last updated: 2024-04-17

Locations

1 site across 1 country: Germany