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ESR 5, SARA CAMERON, MÜNSTER

SARA CAMERON ESR 5, MÜNSTER

Title: The biomechanical effects of different orthotic interventions and their clinical relevance in the daily life of patients with medial compartment knee osteoarthritis. Aim of my project To investigate and compare the underlying biomechanical mechanisms of different orthotic interventions, and examine the relationship of these mechanisms to patient specific and clinically relevant outcomes: physical activity levels, knee confidence, and compliance through individual and collaborative studies. An additional sub-study will focus on biomechanical effects of the interventions on stair ascending and descending. Rationale Orthotic interventions are commonly used as a conservative therapy by patients with knee OA. Devices such as braces and wedged shoes or insoles have been studied extensively, however, despite some promising biomechanical results, the potential benefits of such interventions remain inconclusive. More novel devices have recently been given attention and preliminary studies suggest their usefulness in the conservative treatment of knee OA. As of yet, there is no consensus which intervention is most favourable or which device is most suited to the needs of specific subgroups of patients. An extensive biomechanical comparison of such orthotic interventions will provide a valuable insight for clinical application of orthotics in knee OA.

The medial compartment of the knee is affected approximately 10 times more than the lateral compartment (Ahlback, 1968) in patients with knee OA. This has been attributed to greater medial loading during normal gait with 60-80% of the total knee load passing through the medial compartment (Schipplein et al., 1991). Patients with medial knee osteoarthritis often have a characteristic genu varus deformity due to progressive cartilage loss, joint degradation and joint space narrowing in this compartment. This causes the mechanical axis/ground reaction force vector to pass more medially to the knee centre during gait, increasing the load on the medial compartment and exacerbating the progression of the disease (Raja et al., 2011).

Several biomechanical studies have shown that the dynamic load can be reliably predicted by the external knee adduction moment (EKAM) measured during the stance phase of gait and there is increasing evidence that it is indicative of disease progression and severity (Jones et al., 2013).

The use of orthotic devices has been investigated and implemented as a potential conservative therapy for knee osteoarthritis patients. It is aimed at correcting varus malalignment to alleviate pain, improve physical function and possibly slow progression of the disease (Brouwer et al., 2005).

BRACES

Valgus braces are designed to apply a valgus moment directly at the knee through a three-point bending system to counteract the knee adduction moment (KAM) and lessen the proportion of load on the medial compartment for patients.


Valgus bracing has been shown to effectively reduce the KAM during gait (Draganich et al., 2006; Pollo et al., 2002; Moyer et al., 2015) however the magnitude of results varies considerably. The degree of valgus angulation of the brace is thought to determine the effect size. Pollo et al., 2002 estimated an 11% medial load reduction with a 4⁰ valgus adjustment and 17% with an 8⁰ valgus adjustment of the brace. Patient tolerance of various degrees of valgus limit the realistic clinical application of high angulation and there is a lack of consensus with regards to the recommended degree of angulation in clinical practice guidelines.

Several clinical studies have shown the effectiveness of these devices in reducing pain and improving function (Duivenvoorden et al., 2015; Linderfield et al., 1997; Pollo et al 2002; Richards et al 2005) however it is suggested that the treatment effects of bracing is hampered by poor patient compliance due to discomfort among numerous other difficulties associated with brace use (Moyer et al., 2015). Long term effectiveness of brace wearing is thought to be tempered by decreased use and loss of compliance overtime (Barnes et al., 2002; Giori et al., 2004).

A recent meta-analysis by Moyer et al., (2015), favours valgus brace use with significant improvements in pain and function found. An editorial letter in response to this paper (Hunter, 2015), suggests that future studies should look to identify whether individual patient characteristics such as physical activity or adherence influence the effects of bracing in different subgroups.

INSOLES AND SHOW MODIFICATIONS

Laterally wedged insoles for medial knee osteoarthritis were first proposed in the 1980s (Sasaki and Yasuda, 1987 x2) as a low cost, more tolerable alternative. Sasaki and Yasuda (1987) demonstrated in their preliminary studies that the insole shifted the calcaneus into a valgus position relative to the tibia, thereby correcting the malalignment of the lower limb to a more anatomical position. This was hypothesised to reduce the excessive load on the medial knee by causing a small lateral shift of the centre of pressure location of the ground reaction force (Kakihana et al., 2005), thus decreasing the knee joint moment arm and KAM, helping to alleviate pain.

Biomechanical studies show that during walking, the adduction moment can be reduced by approximately 4-12% with lateral wedges (Butler et al., 2007; Hinman et al., 2008; Kakihana et al., 2005; Kerrigan et al., 2002; Shimada et al., 2006). However, literature to date presents some controversy with regards to the consistency of this KAM reduction (Butler et al 2007; Hinman et al 2008; Kakihana et al 2004, 2007; Kerrigan et al 2002; Maly et al., 2002; Nester et al 2003). Individual patient characteristics and disease severity are thought to mediate the biomechanical effects of wedging. Decreases in KAM are observed in patients with mild but not moderate or severe OA (Shimada et al., 2006). It is suggested that different subgroups of patients are more likely to respond however this requires further research (Hinman et al., 2009).

Similarly to brace use, reductions in KAM are related to the degree of wedging of the insole, however it is likely that higher inclinations are likely to cause discomfort (Kerrigan et al., 2002) and may have an effect on the biomechanics of the other joints of the lower limb. A significant increase in subtalar joint motion has been observed when using wedges of 6⁰


(Kakihana et al., 2005; Kakihana et al., 2007). However, no studies as of yet, have shown a significant detrimental effect on frontal plane hip biomechanics (Hinman et al., 2012).

The pain-relieving or functional effects of insoles remain unclear due to the limited number of randomised controlled trials. One study found that NSAIDs intake was reduced in patients who wore a customised lateral wedge for 2 years; however, pain or function was not altered (22, 23). No clinical effect was found for 5⁰ wedges worn for 6 weeks (21). Better outcomes are observed in less severe disease, in younger and in less obese patients (Hinman and Bennell, 2009). One RCT demonstrated no clinical or structural benefits (Bennell et al., 2011) whilst another asserted their appropriateness as a possible alternative to bracing (van Raaij et al 2010).

The effects of wedges over time has been investigated in a few studies and individuals who show the greatest reductions in pain and KAM at baseline show the greatest improvement in function after 3 months (Hinman et al., 2008). Daily usage may influence the clinical outcome; greater clinical benefits were seen in patients who wore the insoles for 5-10 hours per day compared to less than 5 or more than 10 (Toda et al., 2005).

Shoes which are modified to incorporate a lateral wedge have also shown promising results. Fisher et al., (2007) found shoes with either a 4⁰ or 8⁰ valgus sole significantly reduced the knee adduction moment in healthy young adults. Subjects with higher baseline KAM demonstrated greater reductions when using the modified shoe. Previous work in our gait laboratory at UKM, Münster, found wedges which are incorporated into the shoe to be more effective than insoles which are inserted (Rosenbaum et al., 2002).

BRACES VS. INSOLES

Several studies have compared the effects of valgus bracing versus lateral wedges insoles in attempts to provide recommendations as the best intervention and show variable results. Bracing was found to be more effective in reducing pain by one study however biomechanics were not investigated (Sattari and Ashraf 2011). Furthermore, a systematic review found that both knee braces and foot orthoses were effective in reducing pain, stiffness and drug dosage whilst also improving function with no significant adverse effects (van Raaij, 2011), however these conclusions are limited by heterogeneity of studies and poor quality of evidence. A study by Fantini Pagani et al., 2011, compared the immediate biomechanical effects on gait of a valgus knee brace and a lateral wedge insole in 10 knee OA patients. They concluded that the valgus brace was more effective than the insole in reducing knee adduction moment. However clinical effect of this was not investigated and it is questioned whether the very small differences observed may lead to any significant clinical benefits for patients.

Jones et al 2013, conducted a cross-over randomised trial to compare the biomechanical effects of valgus bracing and lateral wedged insoles in knee OA patients. This was the first study to investigate the difference between these interventions beyond the immediate effects in a laboratory setting. Clinical outcomes were also assessed using the WOMAC at laboratory visits as well as self-reported diary cards describing compliance, comfort and pain (VAS) during each 2 week intervention. The results showed that both the brace and the


insole significantly reduce the EKAM and Knee adduction angular impulse (KAAI) in the insole giving the greatest effect. These biomechanical changes were shown to be associated with significant clinical responses of pain improvement and functional subscales.

A recent study by Duivenvoorden et al., 2015 compared the immediate and late (6 week) biomechanical effects of laterally wedged insoles versus valgus bracing. They found no biomechanical alteration at baseline or at 6 weeks when using a brace, only a small effect at baseline for insole use and no significant differences were seen between the two interventions. This study also cannot offer adequate evidence of any clinical significance of the small changes observed in gait analysis. WOMAC and VAS pain scores were recorded in their previous study (van Raaij et al., 2010) and improvements were sustained at 6 weeks despite the apparent diminishment of biomechanical effect.

The literature to date provides inconsistent conclusions and therefore further comparative studies are merited.

AFO/SHOES

An important aspect for the effectiveness of lateral wedge insoles is the stabilisation of the ankle joint. This is commonly done by application of an ankle orthosis or subtalar strapping. Previous studies suggest that this combination could help to avoid the potential compensating coronal plane movements in the foot and/or ankle joint and maximise the effect of medial knee unloading by wedge insoles. Kuroyanagi et al., 2007, found that lateral wedge insoles with subtalar strapping were more effective than without strapping. An alternative mechanism is suggested in which the strapping causes valgus angulation of the talus leading to correction of the femuro-tibial angle, further reducing the medial joint load (Toda et al., 2002).

In light of this, a novel alternative approach which has recently been developed is the use of an ankle-foot orthosis (AFO). Based on the closed kinetic chain biomechanics, through a mechanism which works from the ankle up to the knee, this device should limit varisation of the tibia in the frontal plane and thereby reduce knee varus deformity. The knee joint centre would remain more medial and therefore the KAM be reduced. Preliminary studies have been conducted to assess the effectiveness of AFO’s and offer promising results. In a pilot study of 14 healthy subjects, Fantini Pagani et al (2014) found that compared to a laterally wedged insole, the AFO significantly reduced the KAM and knee lever arm whilst no such effect was found with the insole. Recently, interest has grown in investigating more novel devices such as modified shoes. By virtue of the closed kinetic chain of the lower limb, foot position and motion can influence loading of the knee joint. Therefore various shoe types can be implemented to potentially decrease knee loading. Rocker shoes, variable stiffness shoes and thin-soled, barefoot walking mimicking shoes have been suggested as potential shoe designs to decrease the KAM. As the development of modified shoe designs for OA treatment is a very recent research focus, literature is limited, however, preliminary evidence is promising. Studies have shown a reduction in KAM with modified shoes (Shakoor et al 2008; Fisher et al 2007; Erhart et al 2008).


One RCT found that variable-stiffness walking shoes reduced adduction movement and pain and improved function after 6 months of wear, though this benefit was not statistically significant when compared to constant-stiffness footwear (Erhart et al 2010). Bennell et al (2013) demonstrated that a shoe incorporating both a lateral wedge and a variable-stiffness sole can significantly reduce medial knee joint load. The immediate and longterm effects of mobility shoes which mimic the mechanics of barefoot walking have been investigated by Shakoor et al 2013. They found a reduction in KAM persisted over a 6 month period and found evidence of gait adaptations during this period.

Current OARSI recommendations acknowledge the varied evidence supporting different orthotics and although the use of biomechanical interventions as directed by a specialist is recommended, no definitive recommendation as to which device or which technical features are appropriate is given (OARSI, 2014).KNEE CONFIDENCE

Knee confidence is a qualitative variable assessed in KOOS via a 5 point scale. As the knee plays a crucial role in all weight bearing activities, an individual’s confidence in the joint plays an important role in the patient’s ability to perform tasks of daily living. Worse knee confidence has been shown to be associated with a greater risk of poor function (Colbert et al 2012), higher pain, instability, weaker muscle strength and greater frontal plane joint motion during walking (Skou et al., 2014). The relationship of this variable to biomechanical parameters has not been described previously. Examining the potential improvements in knee confidence with regards to the biomechanical effects of orthotic interventions could add valuable information as to the clinical relevance of different biomechanical devices.


Overarching study design

The overarching study design is shown below (Figure 1). Working in collaboration with ESR 6,

we intend to use this study design to generate data that can be published as sub-studies,

which will be explained throughout this article.

Figure 1: Overarching study design

In- and exclusion criteria

Eligible adults will be required to have symptomatic KOA, with radiographic features in at

least one knee (≥ Kellgren/Lawrence Grade II) and pain on most (≥4) days of the week for


more than 3 months (Farr et al., 2008; Murphy et al., 2008; Felson et al., 2011; Periera et al.,

2011; Schipof et al., 2008; Messier et al., 2004; Guillemin et al., 2011).

Exclusion criteria will be:

- Rheumatoid arthritis.

- Knee replacement, or a scheduled replacement surgery within 3 months at the

beginning of study participation.

- Medical conditions, which could interfere with the activity and test performance,

such as neurologic conditions.

- Use of ambulatory aid (single straight cane) for more than 50% of the ambulatory

time.

The main body of criteria to in- or exclude volunteers in our study is equal across all ‘sub-

studies’. Adjustments for sub-studies will be described in the specific sections of this

research plan.


Study 1. ESR 5 - Immediate biomechanical effects of orthotic interventions and the relationship to knee confidence

Figure 1 – Biomechanical study aim

Rationale

Can be seen above in overall ESR 5 background literature. A study which compares the more

novel orthotics discussed above (which devices will be included TBC) with more established

braces or insoles will add new, relevant information regarding the comparable effects of

each on biomechanical parameters. In addition, by looking for correlations between

biomechanical parameters and a clinically relevant outcome such as knee confidence, new

knowledge regarding the factors contributing to outcomes which influence the daily life of

patients can be added. It is important that the effects of orthotics on biomechanics of the

knee observed in the gait lab setting, are investigated in relation to factors which are of

importance to the patient. Despite a good biomechanical outcome, if the patient’s clinical

outcomes, such as the confidence to use the joint for the activities of daily living are not

improved, then the recommendation of a device as a conservative therapy for knee OA,

should be questioned.

Study description


Gait analysis will be performed to obtain baseline biomechanical measurements of frontal

and sagittal plane kinematics and kinetics. Patients will then be given a randomised

intervention (interventions to be used - TBC but may include a valgus brace, lateral wedged

insole, ankle foot orthosis, modified shoe) and the measurements will be repeated with the

intervention being worn to investigate the immediate effects of the interventions. External

knee adduction moment will be the main outcome investigated. Patients will be asked to

rate their ‘knee confidence in both conditions using a 5 point scale taken from KOOS .

Statistical analysis will compare the magnitude of biomechanical effects between

interventions. Additionally, statistical analysis will determine whether there are correlations

between any observed biomechanical effects of interventions and knee confidence. This

shall provide valuable information regarding which intervention might be more favourable.

In lay-man terms – if all interventions provide a similar biomechanical effect but knee

confidence is higher in the brace group for example, this intervention might be more

favourable for patients as knee confidence is an important outcome which contributes

significantly to the patient’s ability to perform the tasks of daily living and reduce the

functional disability of the disease. The improvement in knee confidence must be

attributable to a factor other than biomechanics associated with the specific intervention.

Conversely, if one intervention shows a more significant effect on reducing the KAM, and a

significantly better improvement in knee confidence when the device is applied, then it

could be assumed that biomechanics have a direct effect on knee confidence and can predict

this patient outcome.

Sample size

A priori power analysis (α=0.05, β=0.80) showed a sample size of 53 participants per intervention. This was based on a recent study by Duivenvoorden et al., (2015) which investigated the effectiveness of insoles and braces in unloading the medial compartment of the knee in knee OA patients.


ESR 5 - Comparison of biomechanical effects of different orthotic interventions during stair ascending and descending

Study Rationale

Despite being one of the most demanding and problematic activities of daily living for knee OA patients, stair climbing has received little attention in biomechanical studies of interventions to date. In the first study of the effect of insoles on stair ascending and descending, Amneh et al., 2014 found a reduction in KAM with the use of lateral wedged insoles. The use of a brace has been shown to reduce KAM during stair climbing by up to 26% (Kutzner et al 2011). A comparison of different interventions and the magnitude of their effect on stairs would provide valuable information which could then be used to determine the relationship of this with clinical results.

Aim

To investigate the biomechanics of different interventions during ascending and descending stairs in patients in medial knee OA.

Study Description

In this cross-sectional study, gait analysis will be performed without an intervention, with intervention 1 and intervention 2 (TBC). Interventions will be given to participants in a random order and the tests will look at the immediate effect on stair ascending and descending. Additional measurements of sagittal plane kinetics and foot-sole pressures may be obtained to assess any changes in pressure points across the foot.

In/Exclusion criteria

Ambulatory aid use allowed? - TBC

Sample size

Unconfirmed but I think about 10 patients?


Study: ‘Compliance to different orthotic interventions in knee osteoarthritis patients’

(Combined with ESR6)

Figure 3: Aim for combined compliance study

Study rationale

Patient compliance is often considered as a limiting factor in the use of orthotics as a

conservative therapy for knee OA patients and as a major limitation of good quality scientific

results. Various factors, such as the brace comfort and wear duration, have an immense

impact on the compliance of KOA patients (Moyer et al., 2015; Duivenvoorden et al., 2015).

Compliance has been addressed in several studies however the data is commonly gathered

subjectively using questionnaires and self-reports, which, is known to be subject to bias and

unreliability (Lee et al., 2015; Shepard et al., 2003; Berendsen et al., 2014). A recent editorial

letter in response to a meta-analysis by Moyer et al, (2015), supports our by strongly


suggesting future studies should focus on compliance as a factor which may influence the

effect of orthotics (Hunter, 2015).

Aim

To objectively determine the compliance to various orthotic interventions. In addition, to

examine the levels of compliance within different knee osteoarthritis subgroups, based on

patient characteristics.

Study description

In this observational study, we will objectively establish the compliance to orthotic

interventions (figure 3). A sensor the size of an average lithium battery will be mounted

inconspicuously into the orthotic devices. The temperatures recorded will then be used to

determine the compliance and amount of time the device was worn. In addition, the

compliance will be compared within various OA subgroups, based on patient characteristics

(e.g. obesity or activity level), since these characteristics are suggested to be of influence

(Moyer et al., 2015).

In- and exclusion criteria

Patients who wish to participate in this sub-study will be asked to participate in the

intervention study as well, where they will be required to wear an orthotic device. Only

medial KOA patients will be allowed to participate, because of the higher prevalence of

medial KOA compared to lateral KOA (Lewek et al., 2004, Arden et al., 2006). We expect that

having orthotics for only one type of KOA is more practical and feasible.

Sample size

See ‘Sample size’ of the next sub-study.


Study: ‘The effect of different orthotic interventions on the physical activity levels in knee

osteoarthritis patients during daily living’ (Combined with ESR6)

Figure 4 – Aim for combined study on effects of orthotics on physical activity levels

Study rationale

Current literature reports inconclusive results over the effects of orthotic interventions on

lower limb biomechanics, and clinical outcomes such as physical functioning and pain

Duivenvoorden et al., 2015; Sattari et al., 2011). Moreover, no study has objectively

examined the effect of different orthotics on physical activity in the daily life of KOA patients.

Aim

To examine the effect of different orthotics on accelerometer-measured activity levels of

knee osteoarthritis patients. Furthermore, to assess how the use of orthotics alters pre-


specified biomechanical parameters of gait, physical functioning and pain in knee

osteoarthritis patients. If possible, associations between these parameters and alterations in

activity levels will be analysed.

Study description

A randomized controlled trial will be performed. After the first week of activity monitoring,

the patients will perform various functional tests and receive an orthotic intervention, which

they will wear for 4 weeks. During the last week of the intervention period, the activity levels

will again be monitored and compared to the pre-intervention activity levels. At the end of

the fourth week, the lab measurements will be repeated to examine the midterm effects of

each intervention on biomechanics, function and pain (figure 4).

In/exclusion criteria

See In/exclusion criteria’ of the previous sub-study.

Sample size

A priori power analysis (α=0.05, β=0.80) showed a sample size of 50 participants per

intervention. It was based on function test data of a similar study design, which examined

the immediate and mid-term effects of foot-orthotics on KOA (Hsieh et al., 2014).


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