Ignite Creation Date:
2024-05-06 @ 4:03 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02443974
Status:
COMPLETED
Last Update Posted:
2016-07-01
First Post:
2015-04-08
Brief Title:
Bracing to Treat Knee Osteoarthritis in Elderly
Sponsor:
Federal University of São Paulo
Organization:
Federal University of São Paulo
Study Overview
Official Title:
Effectiveness of Knee Bracing in Elderly With Knee Osteoarthritis a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-06
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:
Background Osteoarthritis OA is highly prevalent in the elderly with the knee being the most commonly affected joint in this population Knee braces are often used to prevent common problems in knees during daily activities The purpose of these devices is to decrease pain and improve functionality In the literature some studies have tested the effectiveness of unloader brace for valgus or varus However the braces most used in the investigators clinical setting and the less costly ones have not been described in quality studies in the literature There are only few studies on this subject and they are methodologically inadequate There are no studies that compared the effectiveness between the knee brace with metal hinges no alignment and knee brace without metal hinges Objective To evaluate the effectiveness of knee braces on pain function and quality of life in the elderly with knee OA Methods Elderly with knee OA both genders with pain scale 3-7cm on a 10cm pain numeric scale were included Of the 222 patients screened 120 met the eligibility criteria and were randomized to the groups without metal hinges with metal hinges or control group The groups without and with metal hinges received knee brace and were instructed to use it in daily activities every day during three months Assessment for pain NPS function WOMAC and Knee Lequesne and quality of life SF-36 were done at baseline and after 45 90 and 180 days by a blinded assessor
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None