APOS Therapy for Osteoarthritis of the Knee: a Randomized Controlled Trial BIOTOK

Summary

Painful knee osteoarthritis is common and treatments, short of knee replacement, are limited. The investigators plan to test the efficacy of a novel promising device for treatment of knee osteoarthritis affecting the inner part of the knee, the most common location. There are no disease modifying treatments available and therefore there is an emphasis on conservative management techniques to benefit individuals. Many of these treatments (insoles, braces, physiotherapy etc) have been shown to have relative success in individuals but a new novel device is demonstrating better effectiveness in this patient group. APOS (All Phases of Step) therapy consists of a shoe oriented system of care that works by shifting the load across parts of the knee and retraining the lower extremity muscles. Preliminary data suggest impressive favourable reductions in knee pain and a commensurate decrease in knee loading during walking. However, APOS treatment has never been evaluated in a randomised controlled trial even though it is widely used. The investigators propose to conduct a randomised blinded controlled trial of APOS treatment among persons with painful knee osteoarthritis affecting the inside (medial or lateral) of their knees. The investigators will focus on pain outcomes and quality of life. APOS has committed to provide the shoe system and a matched sham device, that they have developed, and will also provide the technicians trained to calibrate the pertupods (balls under the sole of the foot) on the shoe without charge. The research will be undertaken in a University setting for the gait evaluations.

Conditions

• Osteoarthritis, Knee

Interventions

DEVICE

APOS shoe

It consists of two shoes each with two large convex rubber balls called "Pertupods" screwed into the plantar surface of the sole so that a person walks on these balls.

DEVICE

Sham-APOS shoe

It has the same appearance as the APOS shoe, but without the rubber ball attachment on the plantar surface.

Sponsors & Collaborators

• Mäxi Foundation

  collaborator UNKNOWN

• University of Bern

  collaborator OTHER

• Apos Medical and Sports Technology Ltd.

  collaborator INDUSTRY

• Insel Gruppe AG, University Hospital Bern

  lead OTHER

Principal Investigators

• Stephan Reichenbach, PD Dr. med. · Institute of Social and Preventive Medicine (ISPM), University of Bern

• Peter Jüni, Prof. · Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Department of Medicine and Institute of Health Policy, Management and Evaluation, University of Toronto, Canada

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-04-20

Primary Completion

2017-08-15

Completion

2017-08-15

Countries

• Switzerland

Study Locations