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

NCT02363712 | Completed

• 1 other identifier: 475_BIOTOK
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Osteoarthritis, knee; therapy; shoe; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• WOMAC pain subscale

  End of treatment (at 24 weeks)

Secondary Outcomes (9)

• WOMAC pain subscale

  At week 4, 8, 12 and 16

• WOMAC stiffness subscale

  At baseline, at week 4, 8, 12, 16 and 24

• WOMAC disability subscale

  At baseline, at week 4, 8, 12, 16 and 24

• Total WOMAC score

  At baseline, at week 4, 8, 12, 16 and 24

• Overall assessment of disease status on a 7 point likert scale

  At baseline, at week 4, 8, 12, 16 and 24

Study Arms (2)

APOS

EXPERIMENTAL

APOS(All Phase Of Step)-shoe

Device: APOS shoe

Sham APOS

SHAM COMPARATOR

Sham APOS(All Phase Of Step)-shoe

Device: Sham-APOS shoe

Interventions

APOS shoe DEVICE

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.

APOS

Sham-APOS shoe DEVICE

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

Sham APOS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Mäxi Foundation: collaborator
• University of Bern: collaborator
• Apos Medical and Sports Technology Ltd.: collaborator

Study Sites (1)

University of Berne

Bern, 3011, Switzerland

Location

Related Publications (12)

• Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.

  PMID: 19407734 BACKGROUND

• Badley EM, Wang PP. Arthritis and the aging population: projections of arthritis prevalence in Canada 1991 to 2031. J Rheumatol. 1998 Jan;25(1):138-44.

  PMID: 9458217 BACKGROUND

• Rosemann T, Grol R, Herman K, Wensing M, Szecsenyi J. Association between obesity, quality of life, physical activity and health service utilization in primary care patients with osteoarthritis. Int J Behav Nutr Phys Act. 2008 Jan 28;5:4. doi: 10.1186/1479-5868-5-4.

  PMID: 18226211 BACKGROUND

• Grotle M, Hagen KB, Natvig B, Dahl FA, Kvien TK. Prevalence and burden of osteoarthritis: results from a population survey in Norway. J Rheumatol. 2008 Apr;35(4):677-84. Epub 2008 Feb 15.

  PMID: 18278832 BACKGROUND

• Juni P, Reichenbach S, Dieppe P. Osteoarthritis: rational approach to treating the individual. Best Pract Res Clin Rheumatol. 2006 Aug;20(4):721-40. doi: 10.1016/j.berh.2006.05.002.

  PMID: 16979535 BACKGROUND

• Niu J, Zhang YQ, Torner J, Nevitt M, Lewis CE, Aliabadi P, Sack B, Clancy M, Sharma L, Felson DT. Is obesity a risk factor for progressive radiographic knee osteoarthritis? Arthritis Rheum. 2009 Mar 15;61(3):329-35. doi: 10.1002/art.24337.

  PMID: 19248122 BACKGROUND

• Felson DT, McLaughlin S, Goggins J, LaValley MP, Gale ME, Totterman S, Li W, Hill C, Gale D. Bone marrow edema and its relation to progression of knee osteoarthritis. Ann Intern Med. 2003 Sep 2;139(5 Pt 1):330-6. doi: 10.7326/0003-4819-139-5_part_1-200309020-00008.

  PMID: 12965941 BACKGROUND

• Brouwer RW, Jakma TS, Verhagen AP, Verhaar JA, Bierma-Zeinstra SM. Braces and orthoses for treating osteoarthritis of the knee. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD004020. doi: 10.1002/14651858.CD004020.pub2.

  PMID: 15674927 BACKGROUND

• Elbaz A, Mor A, Segal G, Debbi E, Haim A, Halperin N, Debi R. APOS therapy improves clinical measurements and gait in patients with knee osteoarthritis. Clin Biomech (Bristol). 2010 Nov;25(9):920-5. doi: 10.1016/j.clinbiomech.2010.06.017. Epub 2010 Jul 16.

  PMID: 20637534 BACKGROUND

• Bar-Ziv Y, Beer Y, Ran Y, Benedict S, Halperin N. A treatment applying a biomechanical device to the feet of patients with knee osteoarthritis results in reduced pain and improved function: a prospective controlled study. BMC Musculoskelet Disord. 2010 Aug 10;11:179. doi: 10.1186/1471-2474-11-179.

  PMID: 20698991 BACKGROUND

• Trelle S, Reichenbach S, Wandel S, Hildebrand P, Tschannen B, Villiger PM, Egger M, Juni P. Cardiovascular safety of non-steroidal anti-inflammatory drugs: network meta-analysis. BMJ. 2011 Jan 11;342:c7086. doi: 10.1136/bmj.c7086.

  PMID: 21224324 BACKGROUND

• Reichenbach S, Felson DT, Hincapie CA, Heldner S, Butikofer L, Lenz A, da Costa BR, Bonel HM, Jones RK, Hawker GA, Juni P. Effect of Biomechanical Footwear on Knee Pain in People With Knee Osteoarthritis: The BIOTOK Randomized Clinical Trial. JAMA. 2020 May 12;323(18):1802-1812. doi: 10.1001/jama.2020.3565.

  PMID: 32396180 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Stephan Reichenbach, PD Dr. med.

  Institute of Social and Preventive Medicine (ISPM), University of Bern

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 16, 2015
• Study Start: April 20, 2015
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: November 13, 2019

Record last verified: 2019-11

Locations

CH (1)