Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001010886
Ethics application status
Approved
Date submitted
18/09/2012
Date registered
19/09/2012
Date last updated
20/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of knee bracing in people with osteoarthritis after knee reconstruction
Scientific title
The effect of a targeted brace on biomechanics, pain and function in people with post-traumatic knee osteoarthritis after knee reconstruction
Secondary ID [1] 262592 0
N/A
Universal Trial Number (UTN)
Trial acronym
POAK: Post-traumatic OsteoArthritis of Knee
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-traumatic knee osteoarthritis 268270 0
Condition category
Condition code
Musculoskeletal 268404 268404 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 268405 268405 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Commercially available Donjoy unloader knee brace (OA Adjuster) will be tested. The knee brace is designed to control abnormal sagittal and transverse plane rotations, and reduce frontal plane malalignment. The knee brace can be adjusted in the frontal plane to offload either medial or lateral knee compartment for use in medial and lateral knee OA, respectively. The degree of frontal plane adjustment is based on individual’s comfort during walking.

Brace will be fitted on the participants' knee by one investigator, who will be responsible for taking outcome measures. A second investigator will open the sealed opaque envelope indicating the order of the brace conditions and apply each test condition to the brace:
Arm 1: anterior-posterior support with frontal plane adjustment (adjusted)

Arm 2: anterior-posterior support without frontal plane adjustment (unadjusted). The brace condition will be set immediately prior to testing.

The outcome investigator will remain blinded to test condition (adjusted vs. unadjusted) for the study duration.



Exposure: The brace will be worn during biomechanical assessment for 90-120 minutes. Following baseline (no brace) functional measures (week 0), participants will regularly (daily) wear the adjusted brace during functional activities e.g. walking, stairs and running for a 4-week period. Functional measures will be repeated after 4 weeks of brace wear in adjusted and unadjusted brace conditions (30 minutes). Participants will then be asked to continue to wear the adjusted brace regularly for a further 3 months, after which time they will complete patient-reported outcome measures.
Intervention code [1] 266926 0
Treatment: Devices
Intervention code [2] 266927 0
Rehabilitation
Comparator / control treatment
The immediate effects of the knee brace (adjusted and unadjusted) on biomechanics will be compared against a no-treatment control (no brace). The duration between each of the three conditions (control, adjusted brace, and unadjusted brace) will be approximately 30 minutes. The three conditions will be compared at test time.
Control group
Active

Outcomes
Primary outcome [1] 287903 0
Primary outcome: Biomechanics
Kinematic, ground reaction force and electromyography (EMG) data will be collected during walking, hopping and stair-stepping under three conditions: no brace, adjusted brace, unadjusted brace (with the two brace conditions applied in a random order).
Timepoint [1] 287903 0
Biomechanics
Time point: 0 minutes (baseline), 60 minutes (brace condition 1) and 120 minutes (brace condition 2)
Primary outcome [2] 288010 0
Primary outcome: Functional tests
Functional tests of hopping, stair stepping and stair climbing tasks will be performed without the brace.
Timepoint [2] 288010 0
Functional
Time point: Baseline (week 0) and week 4
Secondary outcome [1] 299029 0
Pain and confidence will be measured on a 100 mm visual analogue scale during walking, hopping, stair-stepping tasks (while undergoing biomechanical assessment).
Timepoint [1] 299029 0
Pain and confidence
Time point: Immediately after each task without brace, adjusted brace, unadjusted brace at week 0.
Secondary outcome [2] 299271 0
Pain, confidence, stability and ease of performance will be measured on a 100 mm visual analogue scale during hopping, stair stepping and climbing tasks (during functional tests).
Timepoint [2] 299271 0
Pain, confidence, stability and ease
Time point: Immediately after each task at week 0 and week 4.
Secondary outcome [3] 299272 0
International Knee Documentation Committee Subjective Knee Evaluation Form
Timepoint [3] 299272 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [4] 299273 0
Anterior Knee Pain Scale
Timepoint [4] 299273 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [5] 299274 0
Patellofemoral Osteoarthritis Outcome Score
Timepoint [5] 299274 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [6] 299275 0
Tegner Activity Scale
Timepoint [6] 299275 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [7] 299276 0
Lysholm Score
Timepoint [7] 299276 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [8] 299277 0
International Physical Activity Questionnaire
Timepoint [8] 299277 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [9] 299278 0
Tampa Kinesiophobia Scale
Timepoint [9] 299278 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [10] 299279 0
Pain Coping Attempts Scale of the Coping Strategies Questionnaire
Timepoint [10] 299279 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [11] 299280 0
EuroQol
Timepoint [11] 299280 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [12] 299281 0
Knee Self-Efficacy Scale
Timepoint [12] 299281 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [13] 299282 0
Arthritis Self-Efficacy Scale
Timepoint [13] 299282 0
Baseline (week 0) and after 4 months of brace wear
Secondary outcome [14] 299283 0
Brace compliance diary
Timepoint [14] 299283 0
Weekly (Starting at week-1 and finishing at month-4)

Eligibility
Key inclusion criteria
i) ACL reconstruction 5 to 20 years previously; ii) aged at least 18 years at the time of ACL reconstruction; iii) knee pain severity of greater than or equal to 4 on an 11-point numerical pain scale during aggravating activities; iv) pain during aggravating activities present on most days during the past month; and v) radiographic OA severity of greater than or equal to 2 on Kellgren and Lawrence grading (Kellgren, 1957).
Minimum age
23 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) concomitant pain from hip or lumbar spine; ii) recent knee injections (3 months); iii) planned lower limb surgery in the following 6 months; iv) body mass index of less than or equal to 35; v) knee or hip arthroplasty or osteotomy; vi) physical inability to undertake testing procedures; vii) inability to understand written and spoken English; and viii) pregnant or breastfeeding (contraindications to x-ray).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Following provision of informed consent, the no brace condition will be tested. Following baseline testing (no brace), the second investigator will open the envelope that indicates the order of testing the brace conditions (adjusted, non-adjusted). The assessor will remain blinded to test conditions until all analyses have been finalized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple computer generated randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
For the biomechanical assessment, crossover design will be employed. Both unadjusted and adjusted brace conditions will be randomly tested following the no brace condition.

For the functional assessment, all participants will wear the adjusted brace for 4 weeks (single group design). Following the four week adjusted brace intervention both adjusted and unadjusted brace conditions will be randomly tested (crossover design). After the 4 week functional assessment, the participants will continue wearing the adjusted brace for another 3 months (single group design).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285929 0
University
Name [1] 285929 0
The Univeristy of Melbourne
Country [1] 285929 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
DJO Australasia Pty Ltd
Address
PO BOX 2057
Normanhurst NSW 2076
Country
Australia
Secondary sponsor category [1] 284751 0
None
Name [1] 284751 0
Address [1] 284751 0
Country [1] 284751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287955 0
Human Research Ethics Committee
Ethics committee address [1] 287955 0
Melbourne Research office
The University of Melbourne, VIC 3010
Australia
Ethics committee country [1] 287955 0
Australia
Date submitted for ethics approval [1] 287955 0
Approval date [1] 287955 0
10/09/2012
Ethics approval number [1] 287955 0
1238328

Summary
Brief summary
Injury to the ACL is a well-recognized risk factor for post-traumatic knee osteoarthritis (OA). Degenerative radiographic changes are evident in 50-70% of people 10-15 years after the injury. In such cases, surgical reconstruction does not typically improve OA prognosis. Since knee OA has the potential to have a substantial negative impact on an individual, affecting their quality of life, physical function, and work status, it is important that this subgroup of individuals be investigated.

It is well established that knee biomechanics, including joint motions and loads, are altered following ACL injury, and are not restored with surgical reconstruction. These biomechanical changes are frequently reported as a cause of cartilage damage and subsequent post-traumatic knee OA, due to changes in joint contact pressures and load distribution. Therefore, the focus of this program of research will be directed towards an intervention that may restore more normal knee joint biomechanics. The targeted brace (Donjoy unloader brace) has the potential to enhance knee joint function. It is primarily designed to control abnormal sagittal and transverse plane movements associated with ACL reconstruction, in addition to correcting frontal plane malalignment, which is a common feature of knee OA. The brace is targeted to an individual by compartmental distribution of OA (medial or lateral tibiofemoral, TFJ) and frontal plane knee alignment (varus or valgus). The brace can adjusted in the frontal plane to offload either medial or lateral TFJ compartment for use in medial and lateral TFJ OA, respectively. The degree of frontal plane adjustment is based on individual’s comfort during walking. However, no study to date has evaluated the capacity of knee bracing to restore knee joint function in individuals with knee OA following ACL reconstruction. The aims of this study are to evaluate, in individuals with knee OA after ACL reconstruction: i) the immediate effects of the targeted brace on lower limb biomechanics; ii) the short-term (4-week) effects of the targeted brace on pain, confidence and physical function; and iii) the medium-term (4-month) effects of the brace on pain, function and quality of life. Given that the knee brace has the potential to reduce knee pain and enhance physical function in arthritic patients, it is hypothesized that the immediate effects of the brace will be to improve knee joint kinematics, reduce external joint moments (associated with ACLR), reduce pain, as well as improve confidence, physical function and quality of life in these patients.

The findings of this study will reveal whether knee biomechanics in people who have developed knee OA after ACL reconstruction can be altered by the targeted knee brace. It will also reveal whether the targeted brace can reduce pain, improve confidence, function and quality of life. If the brace can modulate the abnormal biomechanics in the reconstructed knee, it may slow OA progression and may be used to prevent the development of OA following ACLR, thus reducing the associated personal and societal costs of this common and debilitating condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32849 0
Address 32849 0
Country 32849 0
Phone 32849 0
Fax 32849 0
Email 32849 0
Contact person for public queries
Name 16096 0
A/Prof Kay Crossley
Address 16096 0
Division of Physiotherapy
School of Health & Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 16096 0
Australia
Phone 16096 0
+61733653008
Fax 16096 0
Email 16096 0
[email protected]
Contact person for scientific queries
Name 7024 0
A/Prof Kay Crossley
Address 7024 0
Division of Physiotherapy
School of Health & Rehabilitation Sciences
The University of Queensland
St Lucia, QLD, 4072
Country 7024 0
Australia
Phone 7024 0
+61733653008
Fax 7024 0
Email 7024 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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