Medial Compartment Knee OsteoarthritisPhase 2/3NCT00331110
Study of How An Ankle Strap Changes Effects of Insole Treatment for Knee Osteoarthritis
A Phase 2/3 study testing Laterally-Wedged Insole with Ankle Strapping and Laterally-Weged Insole in people with Medial Compartment Knee Osteoarthritis, run by University of Iowa at 1 site in United States.
Trial summary
The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static and dynamic lower limb biomechanics. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Medial Compartment Knee Osteoarthritis
- What is being tested?
- Laterally-Wedged Insole with Ankle Strapping and Laterally-Weged Insole
- Type of treatment
- Medical device
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Aug 2006
- Phase
- Phase 2/3
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 45 or over will be included if they have predominantly medial compartment knee OA by American College of Rheumatology criteria, with medial knee pain rated at least 40/100mm on a visual analogue scale on most days of the month during one of the past 3 months.
Who cannot join
- Potential subjects with a body mass index (BMI) of greater than 35 will be excluded to avoid the potential confounding effect of increased weight on the height of the insole. Other exclusion criteria will include: known injury or surgery involving bone or cartilage of the knee or ankle which may alter gait, history of factors which might alter response to use of a laterally wedged insole (e.g. greater or similar reduction in lateral compared with medial femorotibial jont space width on posterior-anterior radiographs, tibial osteotomy, congenital foot problems, fused joints, foot deformity, known limitation of range of motion of the subtalar joint), known neuromuscular disease, co-morbid disease which might confound gait analysis (e.g. hip OA, ankle OA, hallux rigidus, valgus deformity of the midfoot, other symptomatic deformity of the foot, advanced arthroplasty of the hindfoot, previous ankle arthrodesis, unable to walk without a gait aid), current use of an orthotic insole, inability to comply with study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate and Short-Term Analgesic and Biomechanical Effects of a Laterally Wedged Insole With Ankle Strapping for Medial Compartment Knee Osteoarthritis
The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static and dynamic lower limb biomechanics. Using a repeated measures, modified cross-over design, the following aims and hypotheses will be addressed:
Biomechanical Hypotheses
Read more
- Use of the insole with ankle strapping significantly alters hip-knee-ankle (HKA) angle towards 180° or talar valgus angulation.
- Use of the insole with ankle strapping significantly reduces peak knee external varus moment during gait.
- Use of the insole with ankle strapping significantly reduces foot external rotation (out-toeing) or widened base during gait analysis.
- The radiographic HKA angle and tilt angle of the talus will predict knee peak external varus moment during gait.
Clinical Hypotheses
- The use of an insole with ankle strapping over a two-week period will reduce knee pain (Visual analogue scale, and Knee Osteoarthritis Outcome Survey).
Read the detailed description
Osteoarthritis (OA) of the knee is a common cause of pain and disability and the medial compartment is involved most frequently. If conservative mechanical therapies could reduce knee OA symptoms, risks to patients might be minimized through reduction in use of pharmacotherapy or surgery. A lateral heel wedge with strapping of the ankle joint has been reported to induce a similar therapeutic effect to that of proximal tibial osteotomy. It is presumed that the mechanism for this involves correction of genu varum. However, the effects on the static lower limb mechanical axis and the dynamic knee adduction moment, a risk factor for knee OA symptoms and progression, have not been assessed, so the mechanism of effect is currently unknown. The proposed protocol would compare lower limb mechanical alignment (measured by radiographic hip-knee-ankle angle) and dynamic knee varus moment (measured by 3-dimensional gait analysis) with and without the strapped insole to further understanding of the mechanism of effect on subjects with knee OA. Additionally, this protocol would assess analgesia and whether use of the insole reduces known knee joint unloading compensatory mechanisms during gait. Through measurement of radiographic lower limb alignment, dynamic knee varus moment, and ankle/foot static and dynamic angles, a model would be developed relating radiographs with dynamic moments, potentially allowing greater risk stratification for knee OA development and progression through use of radiographs. In addition to elucidating the mechanism of effect of this insole and developing a model for radiographic interpretation, this protocol would be the fist study of this insole involving non-Japanese subjects.
- Conditions
- Medial Compartment Knee Osteoarthritis
- Being tested
- Laterally-Wedged Insole with Ankle Strapping, Laterally-Weged Insole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laterally-Wedged Insole with Ankle StrappingDevice
Laterally-Weged InsoleDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Hip-Knee-Ankle Alignment
Talar Tilt Angle
External Knee Adduction Moment
Pain Assessment
Gait Velocity
Secondary outcomes (2)
Center of Pressure
Foot Progression Angle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startMay 2006
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Compartment Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- Physiatric Association of Spine, Sports and Occupational Rehabilitation, Foundation for Physical Medicine and Rehabilitation
- Investigators
- Neil A Segal, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00331110
- Sponsor's protocol ID
- 200501707
- Status last verified
- Apr 2007
- First submitted
- 26 May 2006
- Last updated
- 3 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Short-Term Analgesic and Biomechanical Effects of a Laterally Wedged Insole With Ankle Strapping for Medial Compartment Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00331110
- Acronym / sponsor ID
- 200501707
- Conditions
- Medial Compartment Knee Osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- Physiatric Association of Spine, Sports and Occupational Rehabilitation, Foundation for Physical Medicine and Rehabilitation
- Study start
- May 2006
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 29 May 2006 (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.
The goal of this project is to assess the effects of an ankle strap on the effectiveness of a laterally-wedged insole with ankle strapping in reducing knee symptoms and improving static and dynamic lower limb biomechanics. Using a repeated measures, modified cross-over design, the following aims and hypotheses will be addressed:
Biomechanical Hypotheses
- Use of the insole with ankle strapping significantly alters hip-knee-ankle (HKA) angle towards 180° or talar valgus angulation.
- Use of the insole with ankle strapping significantly reduces peak knee external varus moment during gait.
- Use of the insole with ankle strapping significantly reduces foot external rotation (out-toeing) or widened base during gait analysis.
- The radiographic HKA angle and tilt angle of the talus will predict knee peak external varus moment during gait.
Clinical Hypotheses
- The use of an insole with ankle strapping over a two-week period will reduce knee pain (Visual analogue scale, and Knee Osteoarthritis Outcome Survey).
Detailed description
Osteoarthritis (OA) of the knee is a common cause of pain and disability and the medial compartment is involved most frequently. If conservative mechanical therapies could reduce knee OA symptoms, risks to patients might be minimized through reduction in use of pharmacotherapy or surgery. A lateral heel wedge with strapping of the ankle joint has been reported to induce a similar therapeutic effect to that of proximal tibial osteotomy. It is presumed that the mechanism for this involves correction of genu varum. However, the effects on the static lower limb mechanical axis and the dynamic knee adduction moment, a risk factor for knee OA symptoms and progression, have not been assessed, so the mechanism of effect is currently unknown. The proposed protocol would compare lower limb mechanical alignment (measured by radiographic hip-knee-ankle angle) and dynamic knee varus moment (measured by 3-dimensional gait analysis) with and without the strapped insole to further understanding of the mechanism of effect on subjects with knee OA. Additionally, this protocol would assess analgesia and whether use of the insole reduces known knee joint unloading compensatory mechanisms during gait. Through measurement of radiographic lower limb alignment, dynamic knee varus moment, and ankle/foot static and dynamic angles, a model would be developed relating radiographs with dynamic moments, potentially allowing greater risk stratification for knee OA development and progression through use of radiographs. In addition to elucidating the mechanism of effect of this insole and developing a model for radiographic interpretation, this protocol would be the fist study of this insole involving non-Japanese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects aged 45 or over will be included if they have predominantly medial compartment knee OA by American College of Rheumatology criteria, with medial knee pain rated at least 40/100mm on a visual analogue scale on most days of the month during one of the past 3 months.
Key exclusion criteria (1 listed)
- Potential subjects with a body mass index (BMI) of greater than 35 will be excluded to avoid the potential confounding effect of increased weight on the height of the insole. Other exclusion criteria will include: known injury or surgery involving bone or cartilage of the knee or ankle which may alter gait, history of factors which might alter response to use of a laterally wedged insole (e.g. greater or similar reduction in lateral compared with medial femorotibial jont space width on posterior-anterior radiographs, tibial osteotomy, congenital foot problems, fused joints, foot deformity, known limitation of range of motion of the subtalar joint), known neuromuscular disease, co-morbid disease which might confound gait analysis (e.g. hip OA, ankle OA, hallux rigidus, valgus deformity of the midfoot, other symptomatic deformity of the foot, advanced arthroplasty of the hindfoot, previous ankle arthrodesis, unable to walk without a gait aid), current use of an orthotic insole, inability to comply with study protocol.
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 |
|---|---|---|
| Laterally-Wedged Insole with Ankle Strapping | Device | – |
| Laterally-Weged Insole | Device | – |
Primary outcome
Hip-Knee-Ankle Alignment
Talar Tilt Angle
External Knee Adduction Moment
Pain Assessment
Gait Velocity
2 secondary outcomes
Center of Pressure
Foot Progression Angle
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 3 Jan 2008.
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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.
Neil A Segal, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Laterally-Wedged Insole with Ankle Strapping and Laterally-Weged Insole in people with Medial Compartment Knee Osteoarthritis, run by University of Iowa 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 1 inclusion and 1 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 3 Jan 2008. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Hip-Knee-Ankle Alignment. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2008.