None listed
Conditions
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 during walking will reduce immediately wearing an Unloader One knee brace compared to not wearing the knee brace; and 2) braced walking following daily use of an Unloader One knee brace over 8 weeks, compared to braced walking at baseline.
Interventions
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
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 week, participants will rate their perceived overall level of compliance with daily brace use on a 11-point numeric rating scale (with terminal descriptors of “have not worn brace at all” and “worn brace completely as instructed").
Sponsors
Australian Government: Commonwealth Innovation Connection Grant
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
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 8 weeks; - Able to travel to undergo x-ray (if required) / MR examinations, and to attend the Centre for Health, Exercise and Sports Medicine (CHESM) human movement lab at the University of Melbourne for testing; - Radiographic medial tibiofemoral joint osteoarthritis*; *Specific inclusion criteria based on a posteroanterior weight-bearing radiograph are i) Kellgren/Lawrence grade 2 or more; ii) anatomic axis angle of less than 181 degrees for females or less than 183 degrees for males, indicating varus alignment based on mechanical axis values using the sex-specific regression equation ; iii) medial tibiofemoral joint narrowing grade greater than lateral tibiofemoral joint narrowing grade; iv) medial compartment osteophyte grade greater than or equal to lateral compartment osteophyte grade.
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 arthritic conditions; - Work restrictions of other commitments that would restrict wearing a knee brace during daily activities; - Current (or within past 6 months) muscular, joint or neurological condition; - Current (or within past 6 months), or intention to use with the next 8 weeks, a knee brace, walking stick or gait aid; - Absolute contraindications to MR imaging
Outcome results
None listed