Knee OsteoarthritisNCT01919736
Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis
A study testing Gait Retraining in people with Knee Osteoarthritis, run by University of California, San Francisco at 1 site in United States.
Trial summary
The objective of this project is to determine the effects of gait-retraining on articular cartilage composition, gait mechanics, pain and function in persons with mild to moderate knee osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Gait Retraining
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Dec 2016
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women
- At least 35 years of age
- Mild OA patients with arthritic knee symptoms and KL score of 1-2
- Severe OA patients with arthritic knee symptoms and KL score of 3-4
- Knee symptoms in OA patients is defined as pain, aching, or stiffness on most days of a month during the past year or use of medication for treatment of knee pain on most days of a month during the past year
- self reported knee pain (defined as medial compartment knee pain at least 1 day per week during each of the 6 weeks prior to participation) and at least 3 of the following 6 clinical indicators: Age>50 years; morning stiffness<30 minutes duration; crepitus on active motion; tenderness of the bony margins of the knee joint; bony enlargement at the knee; and lack of palpable warmth of the synovium
Who cannot join
- current use of investigational drug
- conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, trochanteric bursitis, hip pain, lumbar pain)
- Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the signal knee
- History of other disease that may involve the study joint including systemic inflammatory disease, crystalline disease, knee infection of the signal knee, avascular necrosis, Paget's disease or tumors
- Self reported heart condition that limits any daily physical activity
- Patients who are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
China Basin Imaging Center
San Francisco, California, 94107
About this study
The objective of this project is to determine the effects of gait-retraining on articular cartilage composition, gait mechanics, pain and function in persons with mild to moderate knee osteoarthritis (OA).
Read the detailed description
Variables of gait mechanics during walking have been linked to the onset and progression of knee osteoarthritis (OA). The knee adduction moment is one key variable that has been identified as an important indicator of medial compartment loads across the knee joint. Use of gait-retraining strategies to alter gait movement patterns and lower the knee adduction movement in persons with knee OA is a new and promising direction for the potential intervention in a population in which few strategies have worked successfully.
Factors that affect cartilage composition are crucial to understanding the disease mechanisms in knee OA. A multi-scale approach towards understanding the knee OA disease process by evaluating tissue compositional changes, joint contact mechanics, whole-body neuromuscular dynamics, and functional performance. The results will be the first to show the association between cartilage composition and daily function (performance and patterns) which are implicated in OA development and progression. With the addition of comprehensive muscle testing (cross sectional area/volume assessment using MR, strength testing, muscle activation and co-contraction patterns during daily activities), it will be possible to study the interaction between all major tissues around the knee.
- Conditions
- Knee Osteoarthritis
- Being tested
- Gait Retraining
- Keywords
- knee OA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait RetrainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Moderate gait retraining | Active comparator | a moderate 7 degree toe-in modification Receives: Behavioral: Gait Retraining |
| Mild gait retraining | Active comparator | A 2 degree toe-in gait retraining Receives: Behavioral: Gait Retraining |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of moderate versus mild gait retraining on pain, function,and kinematics and kinetics during gait and stair climing in persons with symptomatic knee OA
Everybody walks a little different. Some people walk with their toes pointed outwards (duck-footed) and other with their toes pointed straight or even inward(pigeon-toed). We will work with participants to teach you how to walk with slightly different toe angle. Participants will be randomly assign to each group and will be taught on this new walking pattern.
Gait modification is a non-surgical treatment that can reduce the KAM (knee adduction moment). Changes to foot progression angle, tibia angle, hip adduction/internal rotation and trunk sway can reduce the KAM from baseline. Modifications involving simultaneous changes to multiple gait parameters have also been shown to reduce KAM.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharmila Majumdar, PhD, Principal investigator, UCSF, Department of Radiology and Biomedical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919736
- Sponsor's protocol ID
- CLOC
- Status last verified
- Nov 2019
- First submitted
- 29 Jul 2013
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loaded and Unloaded Magnetic Resonance (MR) Imaging of Meniscus-Cartilage-Trabecular Bone in Osteoarthritis
- ClinicalTrials.gov ID
- NCT01919736
- Acronym / sponsor ID
- CLOC
- Conditions
- Knee Osteoarthritis
- Keywords
- knee OA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Aug 2013 (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 objective of this project is to determine the effects of gait-retraining on articular cartilage composition, gait mechanics, pain and function in persons with mild to moderate knee osteoarthritis (OA).
Detailed description
Variables of gait mechanics during walking have been linked to the onset and progression of knee osteoarthritis (OA). The knee adduction moment is one key variable that has been identified as an important indicator of medial compartment loads across the knee joint. Use of gait-retraining strategies to alter gait movement patterns and lower the knee adduction movement in persons with knee OA is a new and promising direction for the potential intervention in a population in which few strategies have worked successfully.
Factors that affect cartilage composition are crucial to understanding the disease mechanisms in knee OA. A multi-scale approach towards understanding the knee OA disease process by evaluating tissue compositional changes, joint contact mechanics, whole-body neuromuscular dynamics, and functional performance. The results will be the first to show the association between cartilage composition and daily function (performance and patterns) which are implicated in OA development and progression. With the addition of comprehensive muscle testing (cross sectional area/volume assessment using MR, strength testing, muscle activation and co-contraction patterns during daily activities), it will be possible to study the interaction between all major tissues around the knee.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate gait retraining | Active comparator | Behavioral: Gait Retraininga moderate 7 degree toe-in modification |
| Mild gait retraining | Active comparator | Behavioral: Gait RetrainingA 2 degree toe-in gait retraining |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women
- At least 35 years of age
- Mild OA patients with arthritic knee symptoms and KL score of 1-2
- Severe OA patients with arthritic knee symptoms and KL score of 3-4
- Knee symptoms in OA patients is defined as pain, aching, or stiffness on most days of a month during the past year or use of medication for treatment of knee pain on most days of a month during the past year
Key exclusion criteria (7 listed)
- current use of investigational drug
- conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy, trochanteric bursitis, hip pain, lumbar pain)
- Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
- History of joint replacement, intra-articular fracture, osteotomy, arthroplasty or meniscectomy of the signal knee
- History of other disease that may involve the study joint including systemic inflammatory disease, crystalline disease, knee infection of the signal knee, avascular necrosis, Paget's disease or tumors
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 |
|---|---|---|
| Gait Retraining | Behavioural | Mild gait retraining, Moderate gait retraining |
Primary outcome
Effects of moderate versus mild gait retraining on pain, function,and kinematics and kinetics during gait and stair climing in persons with symptomatic knee OA
Time frame: up to 6 months
Everybody walks a little different. Some people walk with their toes pointed outwards (duck-footed) and other with their toes pointed straight or even inward(pigeon-toed). We will work with participants to teach you how to walk with slightly different toe angle. Participants will be randomly assign to each group and will be taught on this new walking pattern. Gait modification is a non-surgical treatment that can reduce the KAM (knee adduction moment). Changes to foot progression angle, tibia angle, hip adduction/internal rotation and trunk sway can reduce the KAM from baseline. Modifications involving simultaneous changes to multiple gait parameters have also been shown to reduce KAM.
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 18 Nov 2019.
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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.
Sharmila Majumdar, PhD principal investigator
UCSF, Department of Radiology and Biomedical Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait Retraining in people with Knee Osteoarthritis, run by University of California, San Francisco 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 6 inclusion and 7 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 18 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 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?
Effects of moderate versus mild gait retraining on pain, function,and kinematics and kinetics during gait and stair climing in persons with symptomatic knee OA (time frame: up to 6 months). 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 18 Nov 2019.