Knee OsteoarthritisNCT01597830
The Effects of Specialized Footwear in Osteoarthritis
A study testing Mobility shoe in people with Knee Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
Trial summary
This study evaluates the effects of specialized footwear on pain and knee loading in knee osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and knee pain. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Mobility shoe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Able and willing to give informed consent and to comply with the study protocol and follow-up instructions.
- Symptomatic OA of the knee, as defined by the American College of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are bilateral, then the knee identified by the subject as more symptomatic will serve as the index knee.
- Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the WOMAC.
- Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren and Lawrence (K-L) grading scale.
- Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.
Who cannot join
- Inability or unwillingness to wear study shoes for at least 6 hours/day for 6 days/week
- Knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
- Presence of clinically significant OA of the hip or ankle or pain greater than 20 mm at these sites (WOMAC).
- > 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the mechanical axis (hip-knee angle).
- Predominant lateral compartment OA, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either the index or the contralateral knee.
- Concurrent systemic inflammatory arthropathy,
Show all 11Show fewer
- Prior knee or hip arthroplasty, or surgical arthroscopy of either knee within previous 3 months or history of fracture of either lower extremity within 6 months of study entry.
- Intrinsic foot disease including hallux rigidus, hallux abducto-valgus, metatarsalgia, plantar fasciitis, peripheral neuropathy, or any foot condition that may be exacerbated by particular footwear.
- Intra-articular injection in the index knee: steroids within 6 weeks, hyaluronan derivatives within 4 months.
- Pregnant subjects will be excluded because of the X-rays required.
- Any medical condition that, in the opinion of the PI, would render the subject unable to complete the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
This study evaluates the effects of specialized footwear on pain and knee loading in knee osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and knee pain.
- Conditions
- Knee Osteoarthritis
- Being tested
- Mobility shoe, control shoe
- Keywords
- knee, osteoarthritis, loading
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobility shoeOther
flat, specialized shoe
control shoeOther
control shoe
| Study group | Role | What they receive |
|---|---|---|
| active shoe | Experimental | Not described Receives: Other: Mobility shoe |
| Control | Sham comparator | Not described Receives: Other: control shoe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic knee loading
Measured: 6 months to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startJul 2007
- Primary completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Principal investigator, Najia Shakoor, Rush University Medical Center
- Investigators
- Najia Shakoor, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597830
- Sponsor's protocol ID
- L07041071
- Status last verified
- Apr 2016
- First submitted
- 10 May 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Shakoor N, Sengupta M, Foucher KC, Wimmer MA, Fogg LF, Block JA. Effects of common footwear on joint loading in osteoarthritis of the knee. Arthritis Care Res (Hoboken). 2010 Jul;62(7):917-23. doi: 10.1002/acr.20165.
PubMed 20191571Shakoor N, Lidtke RH, Sengupta M, Fogg LF, Block JA. Effects of specialized footwear on joint loads in osteoarthritis of the knee. Arthritis Rheum. 2008 Sep 15;59(9):1214-20. doi: 10.1002/art.24017.
PubMed 18759313Shakoor N, Block JA. Walking barefoot decreases loading on the lower extremity joints in knee osteoarthritis. Arthritis Rheum. 2006 Sep;54(9):2923-7. doi: 10.1002/art.22123.
PubMed 16947448Shakoor N, Lidtke RH, Wimmer MA, Mikolaitis RA, Foucher KC, Thorp LE, Fogg LF, Block JA. Improvement in knee loading after use of specialized footwear for knee osteoarthritis: results of a six-month pilot investigation. Arthritis Rheum. 2013 May;65(5):1282-9. doi: 10.1002/art.37896.
PubMed 23575871
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Specialized Footwear in Osteoarthritis
- ClinicalTrials.gov ID
- NCT01597830
- Acronym / sponsor ID
- L07041071
- Conditions
- Knee Osteoarthritis
- Keywords
- knee, osteoarthritis, loading
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Jul 2007
- Primary completion
- Aug 2013 (actual)
- First posted
- 14 May 2012 (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.
This study evaluates the effects of specialized footwear on pain and knee loading in knee osteoarthritis. The hypothesis is that this footwear will lead to decreased knee loading and knee pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active shoe | Experimental | Other: Mobility shoe |
| Control | Sham comparator | Other: control shoe |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Able and willing to give informed consent and to comply with the study protocol and follow-up instructions.
- Symptomatic OA of the knee, as defined by the American College of Rheumatology's Clinical Criteria for Classification and Reporting of OA of the Knee. If symptoms are bilateral, then the knee identified by the subject as more symptomatic will serve as the index knee.
- Ambulatory knee pain, defined as the presence of greater than 30 mm of pain while walking on a flat surface (corresponding to question 1 of the visual analog format of the WOMAC.
- Radiographic OA of the study knee of grade 2 or 3, as defined by the modified Kellgren and Lawrence (K-L) grading scale.
- Medial compartment OA, defined as either qualitative joint space narrowing of ≥ 1or the presence of medial bone cyst, sclerosis, or osteophyte.
Key exclusion criteria (11 listed)
- Inability or unwillingness to wear study shoes for at least 6 hours/day for 6 days/week
- Knee flexion contracture of > 15 degrees or inability to ambulate without assistance.
- Presence of clinically significant OA of the hip or ankle or pain greater than 20 mm at these sites (WOMAC).
- > 3 degrees valgus or >12 degrees varus deformity of either knee, defined by the mechanical axis (hip-knee angle).
- Predominant lateral compartment OA, defined as narrowing of the lateral joint space in excess of the narrowing of the medial joint space in either the index or the contralateral knee.
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 |
|---|---|---|
| Mobility shoeflat, specialized shoe | Other | active shoe |
| control shoecontrol shoe | Other | Control |
Primary outcome
Dynamic knee loading
Time frame: 6 months to 2 years
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 6 Apr 2016.
- Background: PubMed 20191571Shakoor N, Sengupta M, Foucher KC, Wimmer MA, Fogg LF, Block JA. Effects of common footwear on joint loading in osteoarthritis of the knee. Arthritis Care Res (Hoboken). 2010 Jul;62(7):917-23. doi: 10.1002/acr.20165.
- Background: PubMed 18759313Shakoor N, Lidtke RH, Sengupta M, Fogg LF, Block JA. Effects of specialized footwear on joint loads in osteoarthritis of the knee. Arthritis Rheum. 2008 Sep 15;59(9):1214-20. doi: 10.1002/art.24017.
- Background: PubMed 16947448Shakoor N, Block JA. Walking barefoot decreases loading on the lower extremity joints in knee osteoarthritis. Arthritis Rheum. 2006 Sep;54(9):2923-7. doi: 10.1002/art.22123.
- Background: PubMed 23575871Shakoor N, Lidtke RH, Wimmer MA, Mikolaitis RA, Foucher KC, Thorp LE, Fogg LF, Block JA. Improvement in knee loading after use of specialized footwear for knee osteoarthritis: results of a six-month pilot investigation. Arthritis Rheum. 2013 May;65(5):1282-9. doi: 10.1002/art.37896.
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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.
Najia Shakoor, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobility shoe in people with Knee Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
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 5 inclusion and 11 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 6 Apr 2016. 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 United States. 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?
Dynamic knee loading (time frame: 6 months to 2 years). 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 NCT01597830, which also lists 4 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 6 Apr 2016.