OsteoarthritisNCT00076453
A Study of Orthotic Shoe Inserts for Controlling Osteoarthritic Knee Pain
A study testing Lateral wedge orthotic shoe inserts and Standard orthotic shoe inserts in people with Osteoarthritis, run by Rush University Medical Center at 1 site in United States.
Trial summary
Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 25 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Lateral wedge orthotic shoe inserts and Standard orthotic shoe inserts
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Dec 2007
- 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 25 years and older
- All sexes
- Healthy volunteers accepted
- 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 and radiographic OA of the knee
- Knee pain upon walking
- Predominant medial compartment OA
Who cannot join
- Knee flexion contracture of greater than 15 degrees or inability to walk without assistance
- Predominant lateral compartment OA of either knee
- Greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis
- Clinically evident OA of the ankle or hip
- Clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics
- Substantial obesity, defined as having body mass index (BMI) greater than 35
Show all 15Show fewer
- Anticipation of surgery involving any joint of either lower extremity in the next 3 years
- Habitual use of inappropriate shoewear that would interfere with adequate use of the orthotic inserts
- Inflammatory arthropathy, such as rheumatoid arthritis, systemic lupus, or active gout
- Chronic infection in any joint of the lower extremities
- History of fracture of either lower extremity within 6 months of study entry
- History of knee or hip arthroplasty or of surgical arthroscopy of either knee within 3 months of study entry
- History of intra-articular injections (glucocorticoids or hyaluronic acid derivatives) in the index knee within 6 months of study entry
- Pregnancy
- Any medical condition which, in the opinion of the investigator, would render the patient unable to comply with the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center, Section of Rheumatology
Chicago, Illinois, 60612
About this study
Official title: Clinical Effects of Altered Biomechanics in Knee Osteoarthritis
Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is a chronic disease causing deterioration of the joint cartilage and the formation of bone spurs at the margins of the joints. Knee OA causes substantial pain, suffering, and disability, as well as enormous economic burden on the patient; unfortunately, treatment provides relief but not a cure. The majority of patients with symptomatic knee OA do not attain satisfactory long-term relief, even with recent advances in pain relievers. Analgesic treatment may relieve the pain but does not improve biomechanics and may even aggravate OA.
Although OA is complex and not completely understood, disease onset and progression are at least partly related to responses by bone and cartilage to biomechanical loading. Devices that promote pressure reduction from the medial knee may provide pain relief while simultaneously protecting the joint from further degeneration; one such device is a lateral wedge orthotic shoe insert. When worn during weight-bearing activity, these inserts have been shown to reduce loading of the medial compartment and may provide pain relief. This study will evaluate the effectiveness of orthotic shoe inserts in controlling and relieving knee OA. The study will also assess improvements in loading biomechanics of the knee.
This is a 3-year study. Patients will be randomly assigned to one of two groups; the first group will receive lateral wedge orthotic inserts and the second group will receive standard orthotic inserts. There will be 10 study visits during the course of the study. Patients will undergo X-rays and bone mineral density testing (DEXA) and 3 blood collections during the course of the study.
- Conditions
- Osteoarthritis
- Being tested
- Lateral wedge orthotic shoe inserts, Standard orthotic shoe inserts
- Keywords
- Knee Pain, Degenerative Arthritis, Cartilage Disease, Non-drug Therapy
- Medical subject headings
- Osteoarthritis, Cartilage Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral wedge orthotic shoe insertsDevice
Customized lateral wedge orthotic shoe inserts
Standard orthotic shoe insertsDevice
Neutral orthotic inserts
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will wear lateral wedge orthotic inserts. Receives: Device: Lateral wedge orthotic shoe inserts |
| 2 | Active comparator | Participants will wear standard orthotic inserts. Receives: Device: Standard orthotic shoe inserts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Measured: Years 2 and 3
Secondary outcomes (1)
Reduction in loading of the medial knee
Measured: Years 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2004 (estimated)
- Study startJun 2003
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Investigators
- Joel A. Block, MD, Principal investigator, Rush University Medical Center, Section of Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076453
- Sponsor's protocol ID
- NIAMS-116
- Other IDs
- 2P50AR039239-16
- Status last verified
- Sep 2011
- First submitted
- 22 Jan 2004
- Last updated
- 27 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Tezcan ME, Goker B, Lidtke R, Block JA. Long-term effects of lateral wedge orthotics on hip and ankle joint space widths. Gait Posture. 2017 Jan;51:36-40. doi: 10.1016/j.gaitpost.2016.09.017. Epub 2016 Sep 21.
PubMed 27693959
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effects of Altered Biomechanics in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00076453
- Acronym / sponsor ID
- NIAMS-116
- Conditions
- Osteoarthritis
- Keywords
- Knee Pain, Degenerative Arthritis, Cartilage Disease, Non-drug Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jun 2003
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 26 Jan 2004 (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.
Osteoarthritis is a degenerative joint disease and is the most common form of arthritis. This study will evaluate the effectiveness of customized shoe inserts in controlling and relieving the pain of knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is a chronic disease causing deterioration of the joint cartilage and the formation of bone spurs at the margins of the joints. Knee OA causes substantial pain, suffering, and disability, as well as enormous economic burden on the patient; unfortunately, treatment provides relief but not a cure. The majority of patients with symptomatic knee OA do not attain satisfactory long-term relief, even with recent advances in pain relievers. Analgesic treatment may relieve the pain but does not improve biomechanics and may even aggravate OA.
Although OA is complex and not completely understood, disease onset and progression are at least partly related to responses by bone and cartilage to biomechanical loading. Devices that promote pressure reduction from the medial knee may provide pain relief while simultaneously protecting the joint from further degeneration; one such device is a lateral wedge orthotic shoe insert. When worn during weight-bearing activity, these inserts have been shown to reduce loading of the medial compartment and may provide pain relief. This study will evaluate the effectiveness of orthotic shoe inserts in controlling and relieving knee OA. The study will also assess improvements in loading biomechanics of the knee.
This is a 3-year study. Patients will be randomly assigned to one of two groups; the first group will receive lateral wedge orthotic inserts and the second group will receive standard orthotic inserts. There will be 10 study visits during the course of the study. Patients will undergo X-rays and bone mineral density testing (DEXA) and 3 blood collections during the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Lateral wedge orthotic shoe insertsParticipants will wear lateral wedge orthotic inserts. |
| 2 | Active comparator | Device: Standard orthotic shoe insertsParticipants will wear standard orthotic inserts. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able and willing to give informed consent and to comply with the study protocol and follow-up instructions
- Symptomatic and radiographic OA of the knee
- Knee pain upon walking
- Predominant medial compartment OA
Key exclusion criteria (15 listed)
- Knee flexion contracture of greater than 15 degrees or inability to walk without assistance
- Predominant lateral compartment OA of either knee
- Greater than 3 degree valgus or greater than 12 degree varus deformity of either knee, as defined by the mechanical axis
- Clinically evident OA of the ankle or hip
- Clinically significant intrinsic foot disease upon podiatric evaluation, including any foot condition that may be aggravated by wearing orthotics
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 |
|---|---|---|
| Lateral wedge orthotic shoe insertsCustomized lateral wedge orthotic shoe inserts | Device | 1 |
| Standard orthotic shoe insertsNeutral orthotic inserts | Device | 2 |
Primary outcome
Pain reduction
Time frame: Years 2 and 3
1 secondary outcome
Reduction in loading of the medial knee
Time frame: Years 2 and 3
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 27 Sep 2011.
- Derived from this study: PubMed 27693959Tezcan ME, Goker B, Lidtke R, Block JA. Long-term effects of lateral wedge orthotics on hip and ankle joint space widths. Gait Posture. 2017 Jan;51:36-40. doi: 10.1016/j.gaitpost.2016.09.017. Epub 2016 Sep 21.
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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.
Joel A. Block, MD principal investigator
Rush University Medical Center, Section of Rheumatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lateral wedge orthotic shoe inserts and Standard orthotic shoe inserts in people with 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 4 inclusion and 15 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 27 Sep 2011. 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. 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?
Pain reduction (time frame: Years 2 and 3). 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 NCT00076453, which also lists 1 linked publication.
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 27 Sep 2011.