None listed
Conditions
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.
Interventions
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 par
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.
Sponsors
DJO Australasia Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
23 Years to No maximum
Healthy volunteers
No
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).
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).
Outcome results
None listed