Agilium Freestep

Clinical Study Summaries This document summarizes clinical studies conducted with the Agilium Freestep. The included studies were identified by a literature search made on PubMed and within the journals Orthopädie-Technik and Medizinisch Orthopädische Technik.

Agilium Freestep – Clinical Study Summaries

Otto Bock Clinical Research & Services

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Table of content: 1 Overview table ....................................................................................................................... p 3 2 Summaries of categories ..................................................................................................... p 4-12 Biomechanics – Static measures ......................................................................................... p 5 Biomechanics – Gait analysis .............................................................................................. p 8 Clinical Effects & Satisfaction ............................................................................................p 11 3 Summaries of individual studies .......................................................................................... p 14-27 Menger et al. 2016 ...........................................................................................................p 15 Fantini-Pagani et al. 2013 ..................................................................................................p 18 Schmalz et al. 2011 ..........................................................................................................p 22 Schmalz et al. 2006 ..........................................................................................................p 25 4 Copyright .............................................................................................................................p 28

Agilium Freestep – Clinical Study Summaries

Otto Bock Clinical Research & Services

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1 Overview table The summaries are organized in three levels depending on the detail of information. The overview table (Level 1) lists all the relevant publications dealing with a particular product (topic) as well as researched categories (e.g. gait analysis, clinical effects, satisfaction, etc). By clicking on underlined categories, a summary of all the literature dealing with that category will open (Level 2). For those interested to learn more about individual studies, a summary of the study can be obtained by clicking on the relevant reference (Level 3). Category Reference Functions and Activities Author

Year

Menger

2016

Biomechanics – Static measures

Biomechanics – Gait analysis

x

x

Schmalz

2011

x

x

Schmalz

2006

x

x

3

3

Agilium Freestep – Clinical Study Summaries

EMG

Functional tests

Clinical effects

Satisfaction

x

Fantini-Pagani 2013

Total number: 3

X-Ray

Participation

0

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0

0

x

x

2

1

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2 Summaries of categories On the following pages you find summaries of categories researched in several studies (e.g. gait analysis, clinical effects, satisfaction, etc.). At the end of each summary you will find a list of reference studies contributing to the content of the particular summary.

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Biomechanics – Static measures Major Findings

With Agilium Freestep:

The knee angle in the frontal plane is significantly reduced  Agilium Freestep in different adjustments: significantly decreased knee

angle in all conditions, indicating a change from varus to valgus position (Fantini-Pagani et al. 2013) [sic]

The knee lever arm in the frontal plane is significantly reduced Knee lever arm = distance between the joint center to the vector of the ground reaction force  Agilium Freestep + 10mm shoe wedge: significantly reduced length of the

knee lever arm with both, medial and lateral shoe wedge (Schmalz et al. 2006)  Agilium Freestep in different adjustments: significantly reduced length of

the knee lever arm in all conditions (Fantini-Pagani et al. 2013)

The vertical component of the ground reaction force shifts laterally:  Patients: lateral shift by 13mm (Schmalz et al. 2011)  Subjects: lateral shift by 11mm (Schmalz et al. 2011)

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Clinical Relevance

Osteoarthritis (OA) is a degenerative joint disease and the leading cause of pain and disability in elderly people worldwide (Hinman et al. 2005). The prevalence of OA increases with age (O’Reilly et al. 1998). Symptomatic knee OA affects 10% of persons over age 55 (Peat at al. 2001) and 12% of persons older than 60 years (Felson et al. 2009). The medial tibiofemoral compartment is affected most frequently (Chang et al. 2005). Patients suffer from pain, stiffness, decreased range of joint motion and a sensation of instability and buckling of the affected knee. These problems may limit the ability to rise from a chair, stand comfortably, walk or climb stairs (Felson et al. 2009, Kaufman et al. 2001). The cause of OA is a non-physiological load distribution due to kinematic changes in the knee joint. A rotational offset from the normal position causes a shift in the load-bearing articular surfaces. Furthermore, a varus deformity of the leg axis leads to a long lever arm between the knee joint center and the vector of the ground reaction force, inducing a high external adduction moment. In a long term, these mechanisms lead to a damaged cartilage (Andriacchi et al. 2004, Felson et al. 2009, Vincent et al. 2012). In easy words this means, that the forces, acting at the joint, are high, when the knee lever arm in the frontal plane is long, because of a varus malalignment. The length of the knee lever arm is correlated with a high knee adduction moment, which is an indicator for a high pressure in the knee. The Agilium Freestep is used in unicompartimental OA. It is an AFO (ankle-footorthosis) that reduces the eversion of the foot. Biomechanical studies showed that this shifts the vector of the ground reaction force closer to the center of the knee joint. As a result, the external adduction moment is reduced (Schmalz et al. 2006, Schmalz et al. 2011, Fantini-Pagani et al. 2013).

Summary

Three biomechanical studies have evaluated the effectiveness of the Agilium Freestep: Schmalz et al. (2006) observed a significant reduction of the knee lever arm of the GRF in the frontal plane and a significantly decreased knee adduction moment with Agilium Freestep in combination with shoe wedges. Schmalz et al. (2011) investigated the Agilium Freestep without shoe wedges. Also here, a significant reduction of the knee lever arm of the GRF in the frontal plane and a significantly decreased knee adduction moment with Agilium Freestep could be shown. Fantini-Pagani et al. (2013) conducted their study with subjects that showed a tendency towards a knee varus alignment. The former results could be confirmed. Significant reductions were seen in the knee lever arm and the knee adduction moment. Furthermore, first clinical results show that pain was reduced by up to 51% (Schmalz et al. 2011). Thus, Agilium Freestep can alter the load distribution within the knee joint and thereby relieve the affected compartment. The use of this AFO, designed to offload the medial or lateral knee compartment, represents an alternative for conservative treatment of knee OA.

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References of summarized studies

Fantini-Pagani, C. H., Willwacher, S., Benker, R., & Brüggemann, G.-P. (2013). Effect of an ankle-foot orthosis on knee joint mechanics: A novel conservative treatment for knee osteoarthritis. Prosthet Orthot Int., 38(6): 481-491. Schmalz, T., Blumentritt, S., & Drewitz, H. (2011). Die Nutzung von Unterschenkelorthesen im Rahmen der konservativen Behandlung der Gonarthrose. The application of orthoses for the lower leg in conservative treatment of gonarthrosis. MOT: Medizinisch Orthopädische Technik, 5: 68-78. Schmalz, T., Blumentritt, S., Drewitz, H., & Freslier, M. (2006). The influence of sole wedges on frontal plane knee kinetics, in isolation and in combination with representative rigid and semi-rigid ankle-foot-orthoses. Clinical Biomechanics (Bristol, Avon), 21(6): 631-639. DOI: 10.1016/j.clinbiomech.2006.02.004.

Other References

Andriacchi, T. P., Mündermann, A., Lane Smith, R., Alexander, E. J., Dyrby, Chris, O., & Koo, S. (2004). A Framework for the in Vivo Pathomechanics of Osteoarthritis at the Knee. Annals of Biomedical Engineering, 32(3): 447–457. Chang, A., Hayes, K., Dunlop, D., Song, J., Hurwitz, D., & Sharma, L. (2005). Hip abduction moment and protection against medial tibiofemoral osteoarthritis progression. Arthritis & Rheumatism, 52(11): 3515–3519. Felson, D. T. (2009). Developments in the clinical understanding of osteoarthritis. Arthritis Research & Therapy, 11(1): 203-2013. DOI: 10.1186/ar2531. Hinman, R. S., Crossley, K. M., McConnell, J., & Bennell, K. L. (2003). Efficacy of knee tape in the management of osteoarthritis of the knee: blinded randomized controlled trial. Bmj: British Medical Journal, 327(7407): 135-140. DOI: 10.1136/bmj.327.7407.135. Kaufman, K. R., Hughes, C., Morrey, B. F., Morrey, M., & An, K. N. (2001). Gait characteristics of patients with knee osteoarthritis. Journal of biomechanics, 34(7): 907–915. O’Reilly, S. C., Jones, A., Muir, K. R., & Doherty, M. (1998). Quadriceps weakness in knee osteoarthritis: the effect on pain and disability. Annals of the rheumatic diseases, 57(10): 588–594. Peat, G., McCarney, R., & Croft, P. (2001). Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis, 60(2): 91–97. Vincent, K. R., Conrad, B. P., Fregly, B. J., & Vincent, H. K. (2012). The pathophysiology of osteoarthritis: a mechanical perspective on the knee joint. PM&R: Physical Medicine and Rehabilitation, 4(5): S3-9. DOI: 10.1016/j.pmrj.2012.01.020.

 Back to overview table

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Biomechanics – Gait analysis Major Findings

With Agilium Freestep: The knee adduction angular impulse is significantly reduced

The knee adduction moment (KAM) is significantly reduced:  Patients: the KAM is reduced by 22% (Schmalz et al. 2011)  Subjects: the KAM is reduced by 14% (Schmalz et al. 2011)  Agilium Freestep + 10mm shoe wedge: significant reduced length of the

KAM with both, medial and lateral shoe wedge (Schmalz et al. 2006)  Agilium Freestep in different adjustments: significant decreased KAM

(first peak) in all conditions; by 11% in neutral position, by 8% in varus position, by 12% in valgus position (Fantini-Pagani et al. 2013)  Dynamic assessment: the knee adduction moment is significantly reduced

by 11% (Fantini-Pagani et al. 2013)

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Clinical Relevance

Osteoarthritis (OA) is a degenerative joint disease and the leading cause of pain and disability in elderly people worldwide (Hinman et al. 2005). The prevalence of OA increases with age (O’Reilly et al. 1998). Symptomatic knee OA affects 10% of persons over age 55 (Peat at al. 2001) and 12% of persons older than 60 years (Felson et al. 2009). The medial tibiofemoral compartment is affected most frequently (Chang et al. 2005). Patients suffer from pain, stiffness, decreased range of joint motion and a sensation of instability and buckling of the affected knee. These problems may limit the ability to rise from a chair, stand comfortably, walk or climb stairs (Felson et al. 2009, Kaufman et al. 2001). The cause of OA is a non-physiological load distribution due to kinematic changes in the knee joint. A rotational offset from the normal position causes a shift in the load-bearing articular surfaces. Furthermore, a varus deformity of the leg axis leads to a long lever arm between the knee joint center and the vector of the ground reaction force, inducing a high external adduction moment. In a long term, these mechanisms lead to a damaged cartilage (Andriacchi et al. 2004, Felson et al. 2009, Vincent et al. 2012). In easy words this means, that the forces, acting at the joint, are high, when the knee lever arm in the frontal plane is long, because of a varus malalignment. The length of the knee lever arm is correlated with a high knee adduction moment, which is an indicator for a high pressure in the knee. The Agilium Freestep is used in unicompartimental OA. It is an AFO (ankle-footorthosis) that reduces the eversion of the foot. Biomechanical studies showed that this shifts the vector of the ground reaction force closer to the center of the knee joint. As a result, the external adduction moment is reduced (Schmalz et al. 2006, Schmalz et al. 2011, Fantini-Pagani et al. 2013).

Summary

Three biomechanical studies have evaluated the effectiveness of the Agilium Freestep: Schmalz et al. (2006) observed a significant reduction of the knee lever arm of the GRF in the frontal plane and a significantly decreased knee adduction moment with Agilium Freestep in combination with shoe wedges. Schmalz et al. (2011) investigated the Agilium Freestep without shoe wedges. Also here, a significant reduction of the knee lever arm of the GRF in the frontal plane and a significantly decreased knee adduction moment with Agilium Freestep could be shown. Fantini-Pagani et al. (2013) conducted their study with subjects that showed a tendency towards a knee varus alignment. The former results could be confirmed. Significant reductions were seen in the knee lever arm and the knee adduction moment. Furthermore, first clinical results show that pain was reduced by up to 51% (Schmalz et al. 2011). Thus, Agilium Freestep can alter the load distribution within the knee joint and thereby relieve the affected compartment. The use of this AFO, designed to offload the medial or lateral knee compartment, represents an alternative for conservative treatment of knee OA.

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References of summarized studies

Fantini-Pagani, C. H., Willwacher, S., Benker, R., & Brüggemann, G.-P. (2013). Effect of an ankle-foot orthosis on knee joint mechanics: A novel conservative treatment for knee osteoarthritis. Prosthet Orthot Int., 38(6): 481-491. Schmalz, T., Blumentritt, S., & Drewitz, H. (2011). Die Nutzung von Unterschenkelorthesen im Rahmen der konservativen Behandlung der Gonarthrose. The application of orthoses for the lower leg in conservative treatment of gonarthrosis. MOT: Medizinisch Orthopädische Technik, 5: 68-78. Schmalz, T., Blumentritt, S., Drewitz, H., & Freslier, M. (2006). The influence of sole wedges on frontal plane knee kinetics, in isolation and in combination with representative rigid and semi-rigid ankle-foot-orthoses. Clinical Biomechanics (Bristol, Avon), 21(6): 631-639. DOI: 10.1016/j.clinbiomech.2006.02.004.

Other References

Andriacchi, T. P., Mündermann, A., Lane Smith, R., Alexander, E. J., Dyrby, Chris, O., & Koo, S. (2004). A Framework for the in Vivo Pathomechanics of Osteoarthritis at the Knee. Annals of Biomedical Engineering, 32(3): 447–457. Chang, A., Hayes, K., Dunlop, D., Song, J., Hurwitz, D., & Sharma, L. (2005). Hip abduction moment and protection against medial tibiofemoral osteoarthritis progression. Arthritis & Rheumatism, 52(11): 3515–3519. Felson, D. T. (2009). Developments in the clinical understanding of osteoarthritis. Arthritis Research & Therapy, 11(1): 203-2013. DOI: 10.1186/ar2531. Hinman, R. S., Crossley, K. M., McConnell, J., & Bennell, K. L. (2003). Efficacy of knee tape in the management of osteoarthritis of the knee: blinded randomized controlled trial. Bmj: British Medical Journal, 327(7407): 135-140. DOI: 10.1136/bmj.327.7407.135. Kaufman, K. R., Hughes, C., Morrey, B. F., Morrey, M., & An, K. N. (2001). Gait characteristics of patients with knee osteoarthritis. Journal of biomechanics, 34(7): 907–915. O’Reilly, S. C., Jones, A., Muir, K. R., & Doherty, M. (1998). Quadriceps weakness in knee osteoarthritis: the effect on pain and disability. Annals of the rheumatic diseases, 57(10): 588–594. Peat, G., McCarney, R., & Croft, P. (2001). Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis, 60(2): 91–97. Vincent, K. R., Conrad, B. P., Fregly, B. J., & Vincent, H. K. (2012). The pathophysiology of osteoarthritis: a mechanical perspective on the knee joint. PM&R: Physical Medicine and Rehabilitation, 4(5): S3-9. DOI: 10.1016/j.pmrj.2012.01.020.

 Back to overview table

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Clinical Effects & Satisfaction Major Findings

With Agilium Freestep:  Knee pain could be significantly reduced:

o

by 51% after two weeks (Schmalz et al. 2011)

o

by 24.5% (after 6 months) and 30.6% (after 12 months) (Menger et al. 2016)

 WOMAC total score and all subscores improved significantly within one

year during Agilium Freestep use (Menger et al. 2016) Results of 12-month follow-up: Total score: -59,4% o Pain subscore: -59.3% o Stiffness subscore: -55.8% o Physical Function subscore: -59.9%

Clinical Relevance

Osteoarthritis (OA) is a degenerative joint disease and the leading cause of pain and disability in elderly people worldwide (Hinman et al. 2005). The prevalence of OA increases with age (O’Reilly et al. 1998). Symptomatic knee OA affects 10% of persons over age 55 (Peat at al. 2001) and 12% of persons older than 60 years (Felson et al. 2009). Patients suffer from pain, stiffness, decreased range of joint motion and a sensation of instability and buckling of the affected knee. These problems may limit the ability to rise from a chair, stand comfortably, walk or climb stairs (Felson et al. 2009, Kaufman et al. 2001). The results of this observational study with Agilium Freestep are similar to the positive clinical experience with knee braces for the treatment of knee OA (Draper et al. 2000, Finger & Paulos 2002, Hillström et al. 2000).

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The pain reduction in the daily use of Agilium Freestep can be classified as meaningful and should improve the prognosis for increasing capacity in the leisure and professional environments. Furthermore, comfort and handling were rated invariably positive. With regard to these important subjective criteria, the Agilium Freestep seems to be a viable alternative to conventional knee braces, which are sometimes marked by low compliance. (Schmalz et al. 2011) It is concluded, that there is high likelihood for improved compliance with the Agilium Freestep (Schmalz et al. 2011). The Agilium Freestep is used in unicompartimental OA. It is an AFO (ankle-footorthosis) that reduces the pain during activities of daily living and shows a high patient satisfaction. Summary

Four biomechanical studies have evaluated the effectiveness of the Agilium Freestep: Schmalz et al. (2006) observed a significant reduction of the knee lever arm of the ground reaction force (GRF) in the frontal plane and a significantly decreased knee adduction moment with Agilium Freestep in combination with shoe wedges. Schmalz et al. (2011) investigated the Agilium Freestep without shoe wedges. Also here, a significant reduction of the knee lever arm of the GRF in the frontal plane and a significantly decreased knee adduction moment with Agilium Freestep could be shown. Fantini-Pagani et al. (2013) conducted their study with subjects that showed a tendency towards a knee varus alignment. The former results could be confirmed. Significant reductions were seen in the knee lever arm and the knee adduction moment. First clinical results show that pain was reduced by up to 51% after wearing Agilium Freestep for two weeks and that the patient satisfaction is high (Schmalz et al. 2011). Menger et al. (2016) proved the influence of Agilium Freestep on the knee pain over a time period of one year. The pain was significantly reduced after six (-24.5%) and twelve months (-30.6%) when using the orthosis. Another part of this study was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). The total score and all three subscores were improved within one year by nearly 60%. Thus, Agilium Freestep can alter the load distribution within the knee joint and thereby offload the affected knee compartment. The use of this AFO represents an alternative for conservative treatment of knee OA.

References of summarized studies

Fantini-Pagani, C. H., Willwacher, S., Benker, R., & Brüggemann, G.-P. (2013). Effect of an ankle-foot orthosis on knee joint mechanics: A novel conservative treatment for knee osteoarthritis. Prosthet Orthot Int., 38(6): 481-491. Menger, B., Kannenberg, A., Petersen, W., Zantop, T., Rembitzki, I., Stinus, H. (2016). Effects of a novel foot–ankle orthosis in the non-operative treatment of unicompartmental knee osteoarthritis. Arch Orthop Trauma Surg, 136(9):1281-7. Schmalz, T., Blumentritt, S., & Drewitz, H. (2011). Die Nutzung von Unterschenkelorthesen im Rahmen der konservativen Behandlung der Gonarthrose. The application of orthoses for the lower leg in conservative treatment of gonarthrosis. MOT: Medizinisch Orthopädische Technik, 5: 68-78. Schmalz, T., Blumentritt, S., Drewitz, H., & Freslier, M. (2006). The influence of sole wedges on frontal plane knee kinetics, in isolation and in combination with representative rigid and semi-rigid ankle-foot-orthoses. Clinical Biomechanics (Bristol, Avon), 21(6): 631-639. DOI: 10.1016/j.clinbiomech.2006.02.004.

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Other References

Draper, E. R. C., Cable, J. M., Sanchez-Ballester, J., Hunt, N., Robinson, J. R., & Strachan, R. K. (2000). Improvement in function after valgus bracing of the knee. An analysis of gait symmetry. Journal of Bone & Joint Surgery, British Volume, 82(7), 1001-1005. Felson, D. T. (2009). Developments in the clinical understanding of osteoarthritis. Arthritis Research & Therapy, 11(1): 203-2013. DOI: 10.1186/ar2531. Finger, S., & Paulos, L. E. (2001). Clinical and biomechanical evaluation of the unloading brace. The journal of knee surgery, 15(3), 155-8. Hillström, H. J., Brower, D. J., Bhimji, S., McGuire, J., Whitney, K., Snyder, H., Zonay, I., Clayburne, G., Sieck, M., & Schumacher, H. R. (2000). Assessment of conservative realignment therapies for the treatment of varus knee osteoarthritis: Biomechanics and joint pathophysiology. Gait Posture, 11(2), 170-171. Hinman, R. S., Crossley, K. M., McConnell, J., & Bennell, K. L. (2003). Efficacy of knee tape in the management of osteoarthritis of the knee: blinded randomized controlled trial. Bmj: British Medical Journal, 327(7407): 135-140. DOI: 10.1136/bmj.327.7407.135. Kaufman, K. R., Hughes, C., Morrey, B. F., Morrey, M., & An, K. N. (2001). Gait characteristics of patients with knee osteoarthritis. Journal of biomechanics, 34(7): 907–915. O’Reilly, S. C., Jones, A., Muir, K. R., & Doherty, M. (1998). Quadriceps weakness in knee osteoarthritis: the effect on pain and disability. Annals of the rheumatic diseases, 57(10): 588–594. Peat, G., McCarney, R., & Croft, P. (2001). Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care. Ann Rheum Dis, 60(2): 91–97.

 Back to overview table

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3 Summaries of individual studies On the following pages you find summaries of studies that researched Agilium Freestep. You find detailed information about the study design, methods applied, results and major findings of the study. At the end of each summary you also can read the original study authors’ conclusions.

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Reference

Menger B, Kannenberg A, Petersen W, Zantop T, Rembitzki I, Stinus, H. Department of Orthopaedic and Trauma Surgery, School of Medicine, University of Goettingen, Germany.

Effects of a novel foot–ankle orthosis in the nonoperative treatment of unicompartmental knee osteoarthritis Arch Orthop Trauma Surg 2016; 136(9):1281-7. Epub 2016 (Jul 8): DOI: 10.1007/s00402-016-2500-2. Products

Agilium Freestep

Major Findings

With Agilium Freestep compared to no orthosis:

 The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

total score and all subscores improved significantly within one year during Agilium Freestep use: Results of 12-month follow-up: Total score: -59,4% o Pain subscore: o Stiffness subscore: o Physical Function subscore: o

-59.3% -55.8% -59.9%

 With Agilium Freestep, knee pain was significantly reduced after six

(-24.5%) and twelve months (-30.6%).

 The restriction of activities of daily living (ADL) and sport-related activity

decreased over time with Agilium Freestep. Significant improvement of WOMAC total score and subscores with Agilium Freestep 45

WOMAC score

40

Total Score

35 30 25

Physical Function Subscore

20

Pain Subscore

15 10

Stiffness Subscore

5 0 Baseline 3-month 6-month 9-month 12-month follow-up follow-up follow-up follow-up

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Population

Subjects: Drop-outs: Mean age: Affected side: Affected compartment: OA grade classification: Leg axis:

Study Design

25 knee OA patients (15 male, 10 female) 2 60.5 ± 11.7 yrs Left knee= 15 patients; Right knee= 10 patients Medial= 21 patients; Lateral= 4 patients Kellgren-Lawrence: Grade I (8); Grade II (14); Grade III (3) Neutral= 10 patients; Varus deviation= 11 patients; Valgus deviation= 4 patients

3 months

3 months

12-month follow-up (12M-FU)

9-month follow-up (9M-FU)

3 months

6-month follow-up (6M-FU)

3 months

3-month follow-up (3M-FU)

Fiting of Agilium Freestep

Prospective cohort study:

Recorded orthosis use over twelve months: 1 patient: < 4 hours; 17 patients: 4-8 hours; 5 patients: > 8 hours Results Functions and Activities Biomechanics – Static measures

Biomechanics – Gait analysis

Participation X-Ray

EMG

Category

Outcomes

Clinical effects

WOMAC (Western Ontario and McMaster UniversiTotal score ties Osteoarthritis Index)

Knee Pain – VAS (visual analog scale)

Restriction (ADL & sport-related activity

Functional tests

Clinical effects

Satisfaction

Results for Agilium Freestep Baseline vs 3M-FU

Baseline vs 6M-FU

Baseline vs 9M-FU

Baseline vs 12M-FU

-38.6% ++

-49.1% ++

-50.6% ++

-59.4% ++

Pain subscore

-49,5% ++

-49.5% ++

-49.5% ++

-59.3% ++

Stiffness subscore

-25.6% ++

-48.8% ++

-46.5% ++

-55.8% ++

Physical Function subscore

-36.9% ++

-49.3% ++

-51.8% ++

-59.9% ++

Knee pain was significantly reduced with Agilium Freestep at 6- and 12-month follow-up: Baseline vs 3M-FU

Baseline vs 6M-FU

Baseline vs 9M-FU

Baseline vs 12M-FU

-18.4% +

-24.5% ++

-22.4% +

-30.6% ++

ADL and sport-related activity restriction decreased over time with Agilium Freestep. (Measured by four-item Lickert Scale)

* no difference (0), positive trend (+), negative trend (−), significant to baseline condition (++/--), not applicable (n.a.) Agilium Freestep – Clinical Study Summaries

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Author’s Conclusion

“In conclusion, the results of our study suggest that the AFO evaluated here is effective at significantly reducing the pain and stiffness and improving the physical function of patients with mild to moderate unicompartmental osteoarthritis of the knee. The clinical benefits of this AFO appear to be similar to those demonstrated in clinical trials of knee unloader braces, although our study suggests that overall patient compliance with AFOs may be superior to unloader braces. However, additional prospective randomized studies are needed to further characterize this AFO in the treatment of unicompartmental OA.” (Menger et al. 2016)

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Reference

Fantini-Pagani, C. H., Willwacher, S., Benker, R., & Brüggemann, G.-P. German Sport University Cologne, Germany.

Effect of an ankle-foot orthosis on knee joint mechanics: A novel conservative treatment for knee osteoarthritis Prosthetics & Orthotics International 2013; 38 (6): 481-491. DOI: 10.1177/0309364613513297. Products

Agilium Freestep

Major Findings

With Agilium Freestep:

 Static assessment  knee lever arm in the frontal plane decreased significantly  knee angle in the frontal plane decreased significantly  Dynamic assessment  knee adduction moment decreased significantly  knee adduction angular impulse decreased significantly

Population

Subjects: Mean age: Gender: Inclusion criteria:

Agilium Freestep – Clinical Study Summaries

14 healthy subjects 24.0 ± 4.8 years all male - varus knee alignment - absence of pain - no previous injuries of the lower extremity - at least 50mm intercondylar distance

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Study Design

Without orthosis (baseline) Laterally wedged insoles Agilium FreeStep neutral Agilium Freestep 4° varus Agilium Freestep 4° valgus

Data collection of 6 trials

Randomization and Blinded to AFO adjustments

Controlled laboratory study, repeated measurements, randomized, blinded:

Randomized rotation of conditions with data collection after each round

Results Functions and Activities Biomechanics – Static measures

Participation

Biomechanics – Gait analysis

X-Ray

EMG

Functional tests

Clinical effects

Satisfaction

Category

Outcomes

Results for Agilium Freestep compared to condition “without orthosis”

Biomechanics – Static measure

Knee lever arm in the frontal plane (knee lever arm = distance between knee joint centre to the vector of the ground reaction force (GRF))

Sig.*

Laterally wedged insoles No difference (from 59.37 ±11.69 to 58.26 ±10.40 mm)

0

Orthosis neutral

Decrease 9% (from 59.37 ±11.69 to 54.15 ±8.30 mm)

++, †

Orthosis varus

Decrease of 7% (from 59.37 ±11.69 to 55.37 ±10.98 mm)

++

Orthosis valgus

Decrease of 10% (from 59.37 ±11.69 to 53.26 ±10.21 mm)

++, †

Knee angle in the frontal plane Laterally wedged insoles (from 2.24° ±2.73° to 2.26° ±2.61°)

0

Orthosis neutral

(from 2.24° ±2.73° to 0.49° ±2.34°)

++, †

Orthosis varus

(from 2.24° ±2.73° to 0.59° ±2.74°)

++, †

Orthosis valgus

(from 2.24° ±2.73° to 0.34° ±2.29°)

++, †

The knee angle in the frontal plane decreases significantly with AFO, indicating a change from varus to a valgus position [sic] Biomechanics – Gait analysis

Knee adduction moment (KAM, first peak) Laterally wedged insoles No difference (from 0.658 ±0.151 to 0.656 ±0.146 Nm/kg)

0

Orthosis neutral

Decrease of 11% (from 0.658 ±0.151 to 0.586 ±0.123 Nm/kg)

++, †

Orthosis varus

Decrease of 8% (from 0.658 ±0.151 to 0.605 ±0.149 Nm/kg)

++, †

Orthosis valgus

Decrease of 12% (from 0.658 ±0.151 to 0.580 ±0.137 Nm/kg)

++, †

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Functions and Activities Biomechanics – Static measures

Category

Participation

Biomechanics – Gait analysis

X-Ray

Outcomes

EMG

Functional tests

Clinical effects

Satisfaction

Results for Agilium Freestep compared to condition “without orthosis”

Sig.*

Knee adduction angular impulse Laterally wedged insoles No difference (from 0.245 ±0.055 to 0.241 ±0.055 Nm s /kg)

0

Orthosis neutral

Decrease of 5% (from 0.245 ±0.055 to 0.232 ±0.053 Nm s /kg)

++

Orthosis varus

Decrease of 3% (from 0.245 ±0.055 to 0.237 ±0.058 Nm s /kg)

++, ‡

Orthosis valgus

Decrease of 7% (from 0.245 ±0.055 to 0.227 ±0.055 Nm s /kg)

++, †

* no difference (0), positive trend (+), negative trend (−), significant to baseline condition (++), significant to wedges condition (†), significant to valgus condition (‡), not applicable (n.a.)

Mean curves of (a) knee adduction moment, (b) knee lever arm, (c) knee angle and (d) tibia rotation in the frontal plane normalized through the stance phase for all subjects during the different test conditions. The shaded area indicates ±SD of the baseline condition.

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Author’s Conclusion

“In summary, a significant decrease in the KAM could be observed in subjects with knee varus alignment while using an AFO in different adjustments (4° valgus, neutral, and 4° varus). The orthosis was effective in changing the knee joint alignment and the knee joint lever arm in the frontal plane. Long-term effects on the KAM, symptoms, joint function, and compliance in patients with medial knee OA should be investigated in future studies. The use of AFOs designed to change the tibia position and thereby the knee joint alignment in the frontal plane could represent an alternative for conservative treatment of knee OA.” (Fantini-Pagani et al. 2013)

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Reference

Schmalz, T., Blumentritt, S., & Drewitz, H. Research Department, Otto Bock HealthCare GmbH, Göttingen, Germany.

The application of orthoses for the lower leg in conservative treatment of gonarthrosis Die Nutzung von Unterschenkelorthesen im Rahmen der konservativen Behandlung der Gonarthrose MOT: Medizinisch Orthopädische Technik 2011; 5: 68-78. Products

Agilium Freestep (Prototype)

Major Findings

With Agilium Freestep  Knee pain could be reduced by 51% (p ≤ 0.01)  Compliance could be increased

 Static assessment: the vertical component of the ground reaction force

(GRF) shifts significantly towards lateral direction (frontal plane)  Dynamic assessment: the knee adduction moment could be reduced sig-

nificantly

Population

Subjects: Mean age: Gender: Inclusion criteria: OA classification:

12 Patients 64.3 ± 11.8 years 7 male, 5 female Medial knee osteoarthritis OA grade 2 and 3 (1x grade 4)

Control-Group: Mean age:

10 healthy subjects 32.3 ± 7.5 years

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Study Design

Comparative, randomized:

10 minutes

dynamic

Randomized rotation of conditions with data collection after each round

static

Settling-in period

Data collection

Fitting with the AFO

Subjects

2 weeks

dynamic

&

Randomized rotation of conditions with data collection after each round

static

Wearing time

Data collection

Subjective assessment

Fitting with the AFO

Patients

Results Functions and Activities Biomechanics – Static measures

Participation

Biomechanics – Gait analysis

X-Ray

EMG

Functional tests

Clinical effects

Category

Outcomes

Biomechanics – Static measure

Vertical component of the ground reaction force (frontal plane) (positive value: vector passes the knee joint centre laterally; negative value: vector passes the knee joint centre medially)

Biomechanics – Gait analysis

Results for Agilium Freestep compared to no orthosis

Satisfaction

Sig.*

Subjects

Lateral shift of 11mm (from 15 ±12 to 26 ±11 mm)

++

Patients

Lateral shift of 13mm (from -7 ±15 to 6 ±14 mm)

++

Subjects

reduced by 22% (from 0.58 to 0.45 Nm/kg)

++

Patients

reduced by 14% (from 0.73 to 0.63 Nm/kg)

++

Knee adduction moment

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Functions and Activities Biomechanics – Static measures

Participation

Biomechanics – Gait analysis

Category

X-Ray

Outcomes

EMG

Functional tests

Clinical effects

Satisfaction

Results for Agilium Freestep compared to no orthosis

Sig.*

Mean torque MXmax, acting in the frontal plane at the knee joint, a) in healthy subjects and b) in patients with OA of the knee Clinical effect

NAS (0= no pain … 10= extreme pain), mean value during gait Patients

Satisfaction

reduced by 51% (from 7.7 ±1.8 to 3.8 ±1.8 points)

++

Compliance It is concluded, that the compliance is increased with the utmost probability (Schmalz et al. 2011).

* no difference (0), positive trend (+), negative trend (−), significant (++/−−), not applicable (n.a.) Author’s Conclusion

“The treatment of patients with osteoarthritis of the knee with the new AFO seems to be an alternative to the conventional orthoses for gonarthrosis. The clinical outcomes and biomechanical effects are equivalent to those measured with conventional orthoses, but the compliance is probably increased.” (Schmalz et al. 2011)

“In der Versorgung von Gonarthrose-Patienten mit der vorgestellten UnterschenkelOrthese ist eine alternative orthetische Versorgungsmöglichkeit zu den bisher bekannten Gonarthrose-Orthesen zu sehen. Die klinischen Resultate und der biomechanische Effekt hinsichtlich der Belastungsreduktion sind knieübergreifenden Orthesen mindestens gleichwertig, die Akzeptanz durch den Patienten ist jedoch mit hoher Wahrscheinlichkeit erhöht.” (Schmalz et al. 2011)

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Reference

Schmalz, T, Blumentritt, S, Drewitz, H, & Freslier, M. Department of Research, Otto Bock Health Care, Duderstadt, Germany.

The influence of sole wedges on frontal plane knee kinetics, in isolation and in combination with representative rigid and semi-rigid anklefoot-orthoses Clinical Biomechanics (Bristol, Avon) 2006; 21 (6): 631–639 doi:10.1016/j.clinbiomech.2006.02.004. Products

Agilium Freestep (Prototype), Malleo Sprint, shoe wedges (medial, lateral)

Major Findings

With Agilium Freestep or Malleo Sprint in combination with shoe wedges compared to no intervention (shoe only condition):  Static assessment: the vertical component of the ground reaction force

(GRF) shifts significantly to the medial side with AFO + medial wedge and significantly to the lateral side with AFO + lateral wedge  Dynamic assessment: the frontal knee loading could be reduced signifi-

cantly

Population

Subjects: Mean age: Mean height: Mean body mass:

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Study Design

Observational, comparative: Shoe only

Agilium FreeStep + Shoe wedge medial Malleo Sprint + Shoe wedge medial Shoe wedge lateral

Data collection

Randomization

Shoe wedge medial Randomized rotation of conditions with data collection after each round

Malleo Sprint + Shoe wedge medial Agilium FreeStep + Shoe wedge medial

The effect on frontal knee loading was measured during standing and walking with medially and laterally placed wedges under the sole of the shoe. The wedges were also combined with two types of orthotic devices – an Ankle–Foot-Orthosis (AFO) that was rigid in the frontal plane but allowed unrestricted sagittal plane motion (Agilium Freestep) and an ankle support that was semi-rigid in the frontal plane (Malleo Sprint). Results Functions and Activities Biomechanics – Static measures

Participation

Biomechanics – Gait analysis

X-Ray

EMG

Functional tests

Clinical effects

Satisfaction

Category

Outcomes

Results*

Biomechanics – Static measure

Knee lever arm in the frontal plane

Agilium Freestep + 10mm shoe wedge

Malleo Sprint + 10 mm shoe wedge

Only 10 mm shoe wedge

Shoe wedge medial

++

0

0

Shoe wedge lateral

++

0

+

(knee lever arm = distance With medial elevation of the foot, the vertical component between knee joint centre of ground reaction force shifts in a medial direction, to the vector of the ground while lateral elevation causes lateral shifting. [sic] reaction force (GRF)) Biomechanics – Gait analysis

Agilium Freestep + 10 mm shoe wedge

Malleo Sprint + 10 mm shoe wedge

Only 10 mm shoe wedge

Shoe wedge medial

++

0

+

Shoe wedge lateral

++

++

0

Knee adduction moment

A tendency towards an increased adduction moment with medial elevation can be observed. With lateral elevation of the foot, the adduction moment is reduced. [sic] * no difference (0), significant with p ≤ 0.05 (+),significant with p ≤ 0.01 (++)

Author’s Conclusion

„For the treatment of osteoarthritis at early stage, the results of this study support enhancement of the effect produced by shoe wedges by application of an AFO that blocks potential compensating coronal plane movements in foot and/or ankle joint.“ (Schmalz et al. 2006)

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Background information on the study by Schmalz et al., 2006:

The basic idea of this study was to describe the effect of laterally shoe wedges on the load relief of the knee joint, or to describe the reason for the inconsistency of this treatment method, respectively. It was assumed that due to an individually hypermobility in the subtalar joint the mechanical effect of a shoe wedge cannot always be seen at the knee joint. Therefore, attemps were made to “eliminate” these compensatory movements in the subtalar joint by means of a semirigid and rigid ankle brace. The results showed that a significant relief of the knee joint can only be achieved with a combined use of shoe wedge and rigid ankle brace (prototype of Agilium Freestep). These findings led to the conceptual development of the Agilium Freestep and subsequent investigations showed that the relief in the knee joint is primarily caused by the AFO.

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Copyright: © 2014, Otto Bock HealthCare Products GmbH (“Otto Bock”). All Rights Reserved. This document contains copyrighted material. Wherever possible we give full recognition to the authors. We believe this constitutes a ‘fair use‘ of any such copyrighted material according to Title 17 U.S.C. Section 107 of US Copyright Law. If you wish to use copyrighted material from this site for purposes of your own that go beyond ‘fair use‘, you must obtain permission from the copyright owner. All trademarks, copyrights, or other intellectual property used or referenced herein are the property of their respective owners. The information presented here is in summary form only and intended to provide broad knowledge of products offered. You should consult your physician before purchasing any product(s). Otto Bock disclaims any liability related from medical decisions made based on this document. Agilium Freestep – Clinical Study Summaries

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