Clinical Research

Clinical research in the fields of prosthetics and orthotics compares products and treatment methods with respect to their safety and performance. Several of our key products have already undergone testing of this kind at some of the world’s leading hospitals and universities.

We offer our e-learning course so you can refresh your knowledge of the background and terminology relating to clinical studies. In this course, we help familiarise you with the various instruments and terminologies. The e-learning course consists of five modules and requires approx. 1.5 hours.

Clinical studies course

Contact

Otto Bock Healthcare Products GmbH

Dr. Andreas Hahn
Clinical Research and Services
Corporate Vice President

Email: andreas.hahn@remove-this.ottobock.com

Clinical studies relating to prosthetics and orthotics

The most common type of research within prosthetics and orthotics involves biomechanical analysis and clinical studies using standardised measuring instruments.

Biomechanical analyses describe movement by measuring motions in space and the effect of the corresponding forces. This assists us, for example, in assessing how physiological a movement is or to what extent test subjects use residual body structures to compensate for their current limitation.

Clinical studies using standardised and validated measuring instruments review the safety and performance of a medical product. Safety can be evaluated by observing stumbling and falling as well as by using standardised balance tests. Performance indicators for prostheses of the lower limbs are often based on the ability of the user to navigate stairs, ramps, and even or uneven terrain. Gripping patterns and force or tests to check for manual dexterity are often referred to for the upper limbs. Numerous studies in the fields of prosthetics and orthotics also seek to establish an understanding as to how specific medical devices influence everyday activities and the quality of life of users as well as satisfaction and preference.

Prosthetics – lower limb prosthetics

Clinical studies focusing on individual products are outlined in clinical “study summaries”.
Both a synoptic table as well as a summary of individual publications are available.
Also included are summaries of studies which focus on the same aspects (e.g. quality of life, stairs, ramps, etc.)

Please download file:

Genium / Genium X3 – clinically proven to be superior

The clinically proven superiority of the Genium to the C-Leg will be outlined in this brochure.

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Genium - Study summaries

These study summaries compare the Genium to the C-Leg. Additional advantages for the patient are highlighted and discussed.

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C-Leg 4 - first clinical results

The first clinical results of the C-Leg 4 will be presented.

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C-Leg in comparison to mechanical knees – Study summaries

This comparison of the C-Leg to non-microprocessor-controlled knee joint prostheses highlights the advantages for the patient (safety, walking on level surfaces, stairs, everyday activities, quality of life, profitability).

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C-Leg in comparison to other microprocessor-controlled knees – Study summaries

These summaries present studies comparing the C-Leg to microprocessor-controlled knee joint prostheses from other providers.

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C-Leg in limited community ambulators (MOBIS 2) – Study summaries

Particular focus is placed on patients with low activity levels, demonstrating the benefits provided by the C-Leg for this patient group.

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Helix hip – Study summaries

All studies which describe the effect of the new Helix Hip on patients’ walking, quality of life, activity levels etc.

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Harmony system – Study summaries

Advantages offered by vacuum-assisted socket systems in comparison to conventional systems.

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Adjust foot – Study summaries

Comparison of the Adjust foot (multi-axial) to the SACH foot (non-articulating).

Prosthetics – upper limb prosthetics

Clinical studies focusing on individual products are outlined in clinical “study summaries”.
Both a synoptic table as well as a summary of individual publications are available.
There are also summaries of clinical studies focusing on certain relevant issues.

Please download file:

Myoelectric compared to body-powered prostheses – Study summaries

A presentation of individual studies and discussion of the following issues:
• Do amputees require myoelectric prostheses as well as body-powered ones?
• Why and when should children be fitted with a myoelectric prosthesis?

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Comparison of different myoelectric prostheses – Study summaries

A presentation of individual studies and discussion of the following issues:
• Michelangelo Hand
• Compensatory movements with myoelectric prostheses
• Phantom and residual limb pain
• Why and when should children be fitted with a myoelectric prosthesis?

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Training with upper extremity prostheses

Presentation of individual studies with additional focus on training with myoelectric prostheses.

Orthotics

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C-Brace – Study summaries

Comparison of the advantages of the C-Brace SSCO to SCOs and KAFOs with a locked knee with regards to walking on level surfaces, walking on stairs and walking on ramps.

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Patella Pro – Study summaries

Studies describing dynamic recentring of the kneecap (patella) in patients with patellofemoral pain syndrome (PFPS) and comparing the effect of the Patella Pro to a conventional knee support are presented here.

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Agilium Freestep – Study summaries

These summaries include an examination of the biomechanical mode of action of the Agilium Freestep in the standing and walking loading situations and a description of the relief offered in case of unicompartmental knee osteoarthritis.

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Genu Arthro – Study summaries

A presentation of all studies describing the effect of the Genu Arthro knee orthosis on the statics, walking, muscle activity, clinical benefits and patient satisfaction of knee osteoarthritis patients.

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Malleo TriStep – Study summaries

The presented studies demonstrate that the Malleo TriStep is most efficient in terms of stabilising the ankle joint in comparison to Aircast splints and taping.

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Omo Neurexa – Study summaries

The study summaries examine the biomechanical and clinical benefits of orthotic treatment for shoulder subluxation in hemiparetic stroke patients.

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Tübingen hip flexion and abduction orthosis – Study summaries

The studies presented here examine the successful treatment of hip dysplasia in newborns using the Tübingen hip abduction orthosis.

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Walk On – Study summaries

This study summary describes the differences between treating hemiplegic patients with a combination of botulinum toxin (BoNTA) and the WalkOn in comparison to administering BoNTA alone.

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Genu Neurexa – Study summaries

This study summary describes the effect of the Genu Neurexa knee orthosis in preventing genu recurvatum in stroke patients.