Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000622101
Ethics application status
Approved
Date submitted
17/04/2019
Date registered
26/04/2019
Date last updated
24/04/2020
Date data sharing statement initially provided
26/04/2019
Date results information initially provided
24/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Knee bracing for medial arthritis of the knee
Scientific title
Effects of knee bracing on articular contact forces in people with knee osteoarthritis and varus malalignment
Secondary ID [1] 297988 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 312448 0
Varus Malalignment 312449 0
Condition category
Condition code
Musculoskeletal 310999 310999 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 311073 311073 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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").
Intervention code [1] 314231 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319796 0
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 (Materialise, Leuven). We will then utilise the 3D marker trajectories to linearly scale anatomical models of each participant within OpenSim and subsequently use inverse kinematics, inverse dynamics and muscle analysis tools to determine the lower-limb joint kinematics, joint moments and muscle tendon unit kinematics. This data will then be used as inputs into a planar mechanism by the Calibrated EMG-Informed Neuromusculoskeletal modelling toolbox (CEINMS) to solve for, and estimate medial knee joint contact force, normalised to bodyweight.
Timepoint [1] 319796 0
8 weeks follow-up
Secondary outcome [1] 369558 0
Self-reported knee pain subscale of the Knee Osteoarthritis Outcome Score (KOOS), administered via electronic questionnaire
Timepoint [1] 369558 0
8 weeks follow-up
Secondary outcome [2] 369559 0
Self-reported other symptoms subscale of the Knee Osteoarthritis Outcome Score (KOOS), administered via electronic questionnaire
Timepoint [2] 369559 0
8 weeks follow-up
Secondary outcome [3] 369560 0
Self-reported function in daily living subscale of the Knee Osteoarthritis Outcome Score (KOOS), administered via electronic questionnaire
Timepoint [3] 369560 0
8 weeks follow-up
Secondary outcome [4] 369561 0
Self-reported function in sport and recreation subscale of the Knee Osteoarthritis Outcome Score (KOOS), administered via electronic questionnaire
Timepoint [4] 369561 0
8 weeks follow-up
Secondary outcome [5] 369562 0
Self-reported knee related quality of life subscale of the Knee Osteoarthritis Outcome Score (KOOS), administered via electronic questionnaire
Timepoint [5] 369562 0
8 weeks follow-up
Secondary outcome [6] 369716 0
Knee pain will also be assessed with a Numeric Rating Scale rating overall knee pain and knee pain during walking in the past week with terminal descriptors of “no pain” (score 0) to “worst pain possible” (score 10).
Timepoint [6] 369716 0
8 weeks
Secondary outcome [7] 369717 0
Health-related Quality of Life will be measured with the Assessment of Quality of Life (AQoL, version II), administered via electronic questionnaire
Timepoint [7] 369717 0
8 weeks
Secondary outcome [8] 369718 0
Self-efficacy for pain and function: The arthritis self-efficacy scale will assess confidence for managing pain (5 questions), symptoms (6 questions) and physical function (9 questions), administered via electronic questionnaire
Timepoint [8] 369718 0
8 weeks
Secondary outcome [9] 369719 0
Self-reported perceived global change in pain, will be measured on a 7-point scale. The terminal descriptors on the 7-point scales will be “much worse” to “much better”.
Timepoint [9] 369719 0
8 weeks
Secondary outcome [10] 369720 0
Perceived global change in physical function will be measured at the 8-week follow-up on a 7-point scale. The terminal descriptors on the 7-point scales will be “much worse” to “much better”.
Timepoint [10] 369720 0
8 weeks
Secondary outcome [11] 369721 0
Perceived overall global change will be measured on a 7-point scale. The terminal descriptors on the 7-point scales will be “much worse” to “much better”.
Timepoint [11] 369721 0
8 weeks
Secondary outcome [12] 369722 0
Co-intervention use: (e.g. medications and any other treatments specifically for knee pain) will be monitored by a questionnaire/log book
Timepoint [12] 369722 0
8 weeks

Eligibility
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 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.
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Thirty participants with clinically diagnosed medial knee osteoarthritis and varus malalignment will be recruited. We aim to detect an immediate bracing/footwear effect size of 0.3 for medial knee joint contact force. Assuming power of 80% and alpha of 0.05, a correlation between measurement of 0.875 a sample of at least 24 participants is required. Allowing for 20% loss to follow-up, we will recruit 30 participants into the study.

Descriptive statistics (i.e. means and standard deviations) will be used to summarise participants characteristics and self-reported measures, assess feasibility of the bracing (e.g. participant retention), adherence to the intervention (e.g. self-reported number of hours wearing the brace) and safety of the intervention (e.g. nature and number of adverse effects). To assess the immediate effect of brace conditions a linear mixed statistical model that includes between condition interactions and random participant effects will be used to assess differences in medial tibiofemoral joint contact force between: 1) braced and unbraced conditions and each intervention in isolation. Paired t-tests will be used to compare baseline and follow-up measures for medial tibiofemoral joint contact force and patient reported outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/04/2019
Actual
30/04/2019
Date of last participant enrolment
Anticipated
1/08/2019
Actual
1/11/2019
Date of last data collection
Anticipated
1/11/2019
Actual
3/01/2020
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 26309 0
3052 - Melbourne University

Funding & Sponsors
Funding source category [1] 302512 0
Commercial sector/Industry
Name [1] 302512 0
Ossur
Country [1] 302512 0
Australia
Primary sponsor type
Government body
Name
Australian Government: Commonwealth Innovation Connection Grant
Address
Department of Industry, Innovation and Science, GPO 2013, Canberra, ACT, 2601
Country
Australia
Secondary sponsor category [1] 302421 0
None
Name [1] 302421 0
Address [1] 302421 0
Country [1] 302421 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303168 0
Psychology Health & Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 303168 0
Alan Gilbert Building, Level 5, The University of Melbourne, 161 Barry Street, Victoria 3010 Australia
Ethics committee country [1] 303168 0
Australia
Date submitted for ethics approval [1] 303168 0
12/02/2019
Approval date [1] 303168 0
26/03/2019
Ethics approval number [1] 303168 0
1853473

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92718 0
Dr Michelle Hall
Address 92718 0
Level 7, Alan Gilbert Building
161 Barry Street
The University of Melbourne, Victoria 3010 Australia
Country 92718 0
Australia
Phone 92718 0
+61432128223
Fax 92718 0
Email 92718 0
[email protected]
Contact person for public queries
Name 92719 0
Dr Michelle Hall
Address 92719 0
Level 7, Alan Gilbert Building
161 Barry Street
The University of Melbourne, Victoria 3010 Australia
Country 92719 0
Australia
Phone 92719 0
+61432128223
Fax 92719 0
Email 92719 0
[email protected]
Contact person for scientific queries
Name 92720 0
Dr Michelle Hall
Address 92720 0
Level 7, Alan Gilbert Building
161 Barry Street
The University of Melbourne, Victoria 3010 Australia
Country 92720 0
Australia
Phone 92720 0
+61432128223
Fax 92720 0
Email 92720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data underlying published results will be provided on request to the Principal Investigator Dr Michelle Hall
When will data be available (start and end dates)?
From date of publishing ~June 2020 until 15 years after publication ~June 2035
Available to whom?
To researchers on a case-by-case basis at the discretion of the Principal Investigator Dr Michelle Hall
Available for what types of analyses?
For any purpose at the discretion of the Principal Investigator
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of a valgus brace on medial tibiofemoral joint contact force in knee osteoarthritis with varus malalignment: A within-participant cross-over randomised study with an uncontrolled observational longitudinal follow-up.2022https://dx.doi.org/10.1371/journal.pone.0257171
EmbaseTibiofemoral contact force differences between flat flexible and stable supportive walking shoes in people with varus-malaligned medial knee osteoarthritis: A randomized cross-over study.2022https://dx.doi.org/10.1371/journal.pone.0269331
N.B. These documents automatically identified may not have been verified by the study sponsor.