Osteoarthritis, KneeBIOTOKNCT02363712
APOS Therapy for Osteoarthritis of the Knee: a Randomized Controlled Trial BIOTOK
A study testing APOS shoe in people with Osteoarthritis, Knee, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- APOS shoe
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Apr 2015to 15 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- Unilateral hemiprosthesis
- Unilateral total joint replacement
- Being treated for cancer
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- APOS shoe, Sham-APOS shoe
- Keywords
- Osteoarthritis, knee, therapy, shoe, Randomized Controlled Trial
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APOS shoeDevice
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-APOS shoeDevice
It has the same appearance as the APOS shoe, but without the rubber ball attachment on the plantar surface.
| Study group | Role | What they receive |
|---|---|---|
| APOS | Experimental | APOS(All Phase Of Step)-shoe Receives: Device: APOS shoe |
| Sham APOS | Sham comparator | Sham APOS(All Phase Of Step)-shoe Receives: Device: Sham-APOS shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC pain subscale
Measured: End of treatment (at 24 weeks)
Secondary outcomes (9)
WOMAC pain subscale
Measured: At week 4, 8, 12 and 16
WOMAC stiffness subscale
Measured: At baseline, at week 4, 8, 12, 16 and 24
WOMAC disability subscale
Measured: At baseline, at week 4, 8, 12, 16 and 24
Total WOMAC score
Measured: At baseline, at week 4, 8, 12, 16 and 24
Overall assessment of disease status on a 7 point likert scale
Data of this secondary outcome have never been collected.
Measured: At baseline, at week 4, 8, 12, 16 and 24
Quality of life after using SF-36
Measured: At baseline, at week 4, 8, 12, 16 and 24
Gait analysis
Consists of velocity, step length, single limb support and cadence
Measured: At baseline, at week 4, 8, 12, 16 and 24
Self-reported health care utilisation
Measured: Up to 24 weeks
Rescue analgesics used
Measured: After 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study start20 Apr 2015
- Primary completion15 Aug 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Mäxi Foundation, University of Bern, Apos Medical and Sports Technology Ltd.
- Responsible party
- Sponsor
- Investigators
- Stephan Reichenbach, PD Dr. med., Principal investigator, Institute of Social and Preventive Medicine (ISPM), University of BernPeter Jüni, Prof., Study director, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363712
- Sponsor's protocol ID
- 475_BIOTOK
- Acronym
- BIOTOK
- Status last verified
- Nov 2019
- First submitted
- 29 Jan 2015
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19407734Badley 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.
PubMed 9458217Rosemann 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.
PubMed 18226211Grotle 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.
PubMed 18278832Juni 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.
PubMed 16979535Niu 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.
PubMed 19248122Felson 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.
PubMed 12965941Brouwer 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.
PubMed 15674927Elbaz 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.
PubMed 20637534Bar-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.
PubMed 20698991Trelle 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.
PubMed 21224324Reichenbach 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.
PubMed 32396180
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomechanical Therapy for Osteoarthritis of the Knee: a Randomized Controlled Trial(BIOTOK)
- ClinicalTrials.gov ID
- NCT02363712
- Acronym / sponsor ID
- BIOTOK / 475_BIOTOK
- Conditions
- Osteoarthritis, Knee
- Keywords
- Osteoarthritis, knee, therapy, shoe, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Mäxi Foundation, University of Bern, Apos Medical and Sports Technology Ltd.
- Study start
- 20 Apr 2015 (actual)
- Primary completion
- 15 Aug 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APOS | Experimental | Device: APOS shoeAPOS(All Phase Of Step)-shoe |
| Sham APOS | Sham comparator | Device: Sham-APOS shoeSham APOS(All Phase Of Step)-shoe |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APOS shoeIt 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 | APOS |
| Sham-APOS shoeIt has the same appearance as the APOS shoe, but without the rubber ball attachment on the plantar surface. | Device | Sham APOS |
Primary outcome
WOMAC pain subscale
Time frame: End of treatment (at 24 weeks)
9 secondary outcomes
WOMAC pain subscale
Time frame: At week 4, 8, 12 and 16
WOMAC stiffness subscale
Time frame: 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
Total WOMAC score
Time frame: 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
Quality of life after using SF-36
Time frame: At baseline, at week 4, 8, 12, 16 and 24
Gait analysis
Time frame: At baseline, at week 4, 8, 12, 16 and 24
Self-reported health care utilisation
Time frame: Up to 24 weeks
Rescue analgesics used
Time frame: After 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Background: PubMed 19407734Centers 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.
- Background: PubMed 9458217Badley 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.
- Background: PubMed 18226211Rosemann 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.
- Background: PubMed 18278832Grotle 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.
- Background: PubMed 16979535Juni 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.
- Background: PubMed 19248122Niu 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.
- Background: PubMed 12965941Felson 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.
- Background: PubMed 15674927Brouwer 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.
- Background: PubMed 20637534Elbaz 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.
- Background: PubMed 20698991Bar-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.
- Background: PubMed 21224324Trelle 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.
- Derived from this study: PubMed 32396180Reichenbach 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Reichenbach, PD Dr. med. principal investigator
Institute of Social and Preventive Medicine (ISPM), University of Bern
Peter Jüni, Prof. study director
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APOS shoe in people with Osteoarthritis, Knee, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC pain subscale (time frame: End of treatment (at 24 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02363712, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.