Knee bracing for medial arthritis of the knee
The University of MelbourneDataset description
Demographic, baseline and 8-week follow-up data from the Knee Bracing trial. 30 patients aged over 50 years with radiographic medial knee osteoarthritis and varus knee alignment participated and were instructed to wear a valgus knee brace for 8 weeks. Feasibility outcomes included change in symptoms, quality of life, confidence, acceptability, adherence and adverse events. All data presented in the results paper (PLoS ONE 17(6): e0257171) available in XLSX format.Date Information
Source Study
Trial name (public)
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12619000622101
Funding
Commercial sector/Industry, Ossur
Scientific enquiries
Dr Michelle Hall
Brief Summary
This study will use patient-specific, electromyogram-informed neuromusculoskeletal modelling to determine the immediate effects of an Ossur Unloader One knee brace on medial knee joint contact force during walking in 30 people with established medial knee osteoarthritis and who have outward (varus) knee alignment. A secondary aim is to determine the short-term (8 week) effects of the valgus brace on symptoms and joint forces. This study will test the hypotheses that medial knee joint force durin .... Read more
Key Inclusion Criteria
Inclusion criteria are based on the American College of Rheumatology clinical and radiographic criteria for knee osteoarthritis - Age greater than or equal to 50 years; - Report knee pain on most days of the past month for greater than 3 months; - Pain on most days (5-7 days/week or 20-30 days/month) in the last month; - Report a minimum pain score of 4 on an 11-point numeric rating scale during walking over the previous week; - Willing to wear a knee brace during daily activities, every day for .... Read more
Key Exclusion Criteria
- Knee or hip replacement on affected side or high tibial osteotomy; - Any knee surgery including arthroscopes in the past 6 months; - Have a body mass index greater than or equal to 36 kg/m2 (due to difficulties in three-dimensional gait analysis); - Awaiting or planning any back or lower-limb surgery within the next 3 months; - Plans to see an orthopaedic surgeon about knee within the next 8 weeks; - Current or past (within 3 months) oral or intra-articular corticosteroid use; - Systemic arthr .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 30
Min. age 50 Years
Max. age No limit
Sex Both males and females
Condition category Knee Osteoarthritis , Varus Malalignment
Condition code Musculoskeletal , Physical Medicine / Rehabilitation
Intervention
Intervention code Treatment: Devices
Participants will be fitted with an Ossür Unloader One© brace on their affected knee during the baseline assessment by a student investigator trained by the manufacturing company. Participants will be instructed to wear the brace every day during activities (i.e. all weightbearing tasks) and take it off at night for 8 weeks. There will be no restriction on amount of time wearing the brace. However, daily brace use in hours and/or minutes, will be self-reported in a weekly log book. After each we .... Read more
Comparison
Control group Uncontrolled
No control group
Outcomes
Outcome: medial knee joint contact force estimated by a patient-specific, emg-informed neuromusculoskeletal model . Kinematic, ground reactive force and EMG data from over-ground walking trials will be organised and processed for use in OpenSim by a software toolbox called MoToNMS within Matlab (Mathworks). We will then integrate 3D anatomical knee surfaces into our anatomical model by segmenting the bones, cartilage and ligaments from knee MRIs using Mimics software (Materiali .... Read more
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
To researchers on a case-by-case basis at the discretion of the Principal Investigator Dr Michelle Hall
Are there any conditions for requesting access to individual participant data?
-
What individual participant data might be shared?
Individual participant data not covered above
De-identified data underlying published results will be provided on request to the Principal Investigator Dr Michelle Hall
What types of analyses could be done with individual participant data?
For any purpose at the discretion of the Principal Investigator
Are there extra considerations when requesting access to individual participant data?
No
When can request for individual data be made (start and end dates)?
From: From date of publishing ~June 2020 until 15 years after publication ~June 2035
To: -