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

November 11, 2019 updated by: University Hospital Inselspital, Berne

Biomechanical Therapy for Osteoarthritis of the Knee: a Randomized Controlled Trial(BIOTOK)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background

Osteoarthritis (OA) is the most common arthritic condition and is one of the leading causes of disability in adults in Switzerland and worldwide (CDC 2009, WHO 2004). With the steady escalation of world life expectancy and constant decline in world birth rates, the incidence and prevalence of OA are expected to rise continuously worldwide throughout the years to come (Badley 1998). In Switzerland, OA is associated with decreased quality of life and frequent use of the health care system (Rosemann 2008).

Currently, no treatment can stop or reverse the progressive joint degeneration caused by OA. Most clinical interventions aim to improve pain and disability as these are the main symptoms afflicting OA patients (Grotle 2008), but managing pain associated with OA of the knee is difficult. Existing non-pharmacological and pharmacological interventions for OA remain insufficient. There are few effective nonsurgical treatments for painful knee OA (Jüni 2006).

OA affects different compartments in the knee, and biomechanical factors play an important role. Observational studies suggest that approximately 60% of affected persons have medial joint involvement (Niu 2009), which is subjected to excessive loading as quantified by the adduction moment across the knee. Bone marrow lesions (BMLs) are seen in knees in most persons with painful knee OA on fat suppressed MRI images. In the MOST cohort study, 80% of persons with medial knee OA and knee pain had medial BMLs. On histology, BMLs represent areas of bone damage with micro-cracks and remodelling. They are strongly related to malalignment such that knees with varus alignment have a high risk of BMLs in the medial compartment and those with valgus alignment have a risk of lateral BMLs (Felson 2003).

Wedges and orthotics which realign the knee have been tested in several randomized trials. This literature has undergone a Cochrane review of orthoses for treating knee OA (Brower 2005) which noted in its conclusion that, 'wearing a laterally wedged orthosis compared to wearing a neutral wedge may not lead to any difference in pain, knee function, or overall well-being'. None of the trials testing orthotics and inserts have shown any significant effect compared to control in terms of knee pain reduction. The other notable finding of almost all of these trials is that they reduced the varus moment across the knee, but by only 6% on average. One possible reason why inserts and orthotics have not worked to reduce pain is that they do not have a large enough realigning effect on the knee (as assessed by the varus moment).

APOS therapy, a new popular medical device, is a shoe system demonstrating potentially improved effectiveness in patients suffering from OA. This footwear has two potential mechanisms of action: 1. it can alter the pattern of knee loading, with reported reductions in the varus moment of 17% (Elbaz 2010), and 2. it retrains lower extremity motor control. Forcing people to avoid walking on the usual wide plantar surface and to instead walk on two rubber balls (APOS shoe) for half an hour at the start of the study, increasing successively (+10 min/week) up to almost 5 hours/day after 24 weeks (not exactly according to scheme but at the physiotherapist's discretion), forces muscular retraining and therefore serves as a built-in exercise intervention.

The investigators therefore aim to compare the efficacy and safety of APOS therapy in a large, pragmatic randomized controlled trial that includes gait analysis to understand the mechanistic action of the device.

Objective

Overall objective: The purpose of this trial is to evaluate whether APOS therapy can improve symptoms compared to Sham APOS therapy in participants with symptomatic knee OA.

Primary objective: The trial will determine the effect of APOS therapy on pain compared to Sham APOS therapy after 24 weeks.

Secondary objective: Secondary objectives will be to determine

  • The effect of APOS therapy on pain compared to Sham APOS therapy after 4, 8, 12 and 16 weeks
  • The effect of APOS therapy on joint stiffness, disability and overall assessment of the disease compared to Sham APOS therapy after 4, 8, 12, 16, and 24 weeks
  • The effect of APOS therapy on quality of life after 4, 8, 12, 16, and 24 weeks
  • The effect of APOS therapy on gait analysis measurements at baseline, after 4, 8, 12, 16 and 24 weeks
  • The effect of APOS therapy on rescue analgesics compared to Sham APOS therapy throughout study duration (24 weeks) and after 24 weeks
  • The time spent on average in the shoe

Methods

This trial is a patient-blind, single-centre, two-arm, parallel-group, 24 weeks (6 months) randomized controlled trial comparing APOS therapy and Sham APOS therapy. While the patients and physicians will be blinded regarding the intervention, the technician applying the shoes will not.

The trial will be conducted among persons with painful knee osteoarthritis. 220 patients will be randomly assigned on a 1:1 basis to one of the two treatments, APOS therapy or Sham APOS therapy. Randomisation will be stratified according to lateral / medial and unilateral / bilateral knee OA status.

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Berne, Switzerland, 3011
        • University of Berne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or non-pregnant women
  • Aged >= 40
  • Outpatient setting
  • ACR clinical criteria for OA of the knee
  • Radiologically confirmed symptomatic uni- or bilateral OA of the knee for at least 6 months
  • Radiological criteria: X-rays showing tibiofemoral knee osteoarthritis defined as at least Kellgren and Lawrence Grade 2
  • At least moderate pain on the WOMAC pain scale (>3 on a standardized scale range from a minimum of 0 to a maximum of 10)
  • Must understand German
  • Informed Consent documented by participant signature

Exclusion Criteria

  • Pregnant women
  • Aged < 40
  • History of an inflammatory rheumatic disease
  • Non-knee musculoskeletal pain as or more severe than the knee pain
  • Glucocorticoid injections in the knees in the previous three month
  • Previous osteotomy
  • Unilateral hemiprosthesis
  • Unilateral total joint replacement
  • Being treated for cancer
  • Participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APOS
APOS(All Phase Of Step)-shoe
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.
Sham Comparator: Sham APOS
Sham APOS(All Phase Of Step)-shoe
Device: Sham-APOS shoe
It has the same appearance as the APOS shoe, but without the rubber ball attachment on the plantar surface.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
WOMAC pain subscale
Time Frame: End of treatment (at 24 weeks)
End of treatment (at 24 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC pain subscale
Time Frame: At week 4, 8, 12 and 16
At week 4, 8, 12 and 16
WOMAC stiffness subscale
Time Frame: At baseline, at week 4, 8, 12, 16 and 24
At baseline, at week 4, 8, 12, 16 and 24
WOMAC disability subscale
Time Frame: At baseline, at week 4, 8, 12, 16 and 24
At baseline, at week 4, 8, 12, 16 and 24
Total WOMAC score
Time Frame: At baseline, at week 4, 8, 12, 16 and 24
At baseline, at week 4, 8, 12, 16 and 24
Overall assessment of disease status on a 7 point likert scale
Time Frame: At baseline, at week 4, 8, 12, 16 and 24
Data of this secondary outcome have never been collected.
At baseline, at week 4, 8, 12, 16 and 24
Quality of life after using SF-36
Time Frame: At baseline, at week 4, 8, 12, 16 and 24
At baseline, at week 4, 8, 12, 16 and 24
Gait analysis
Time Frame: At baseline, at week 4, 8, 12, 16 and 24
Consists of velocity, step length, single limb support and cadence
At baseline, at week 4, 8, 12, 16 and 24
Self-reported health care utilisation
Time Frame: Up to 24 weeks
Up to 24 weeks
Rescue analgesics used
Time Frame: After 24 weeks
After 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Inselspital, Berne

Collaborators

Apos Medical and Sports Technology Ltd.
University of Bern
Mäxi Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2015

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

February 9, 2015

First Posted (Estimate)

February 16, 2015

Study Record Updates

Last Update Posted (Actual)

November 13, 2019

Last Update Submitted That Met QC Criteria

November 11, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 475_BIOTOK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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