Medial Knee OsteoarthritisNCT03843684
Effects of 3D-printed on Lower Extremity Biomechanics in Individuals With Knee Osteoarthritis
A study testing 3D-printed foot orthoses and 5 degrees lateral wedge insoles in people with Medial Knee Osteoarthritis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The purposes of this study are: (1) to determine the kinematics, kinetics, and muscle co-activation ratio of level walking and stair negotiation under three different conditions (shoes only, shoes embedded 3D printed insoles, and shoes embedded 5-degree lateral wedges), (2) to build a detailed patient-specific knee… Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Medial Knee Osteoarthritis
- What is being tested?
- 3D-printed foot orthoses and 5 degrees lateral wedge insoles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Apr 2019to 10 Dec 2019
- 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
- Aged from 50 to 70 years
Who cannot join
- Neuromuscular illness (e.g., Parkinson disease, Neuropathy)
- Predominant lateral or patella-femoral OA
- Previous of planned hip or knee replacement
- Hip or ankle arthritis
- Rheumatoid arthritis
- Unable to walk without a cane or walker
- Unable to walk up and down the stairs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 3D-printed Insoles on Lower Extremity Biomechanics and Knee Joint Loading During Walking and Stair Climbing in Individuals With Knee Osteoarthritis
The purposes of this study are: (1) to determine the kinematics, kinetics, and muscle co-activation ratio of level walking and stair negotiation under three different conditions (shoes only, shoes embedded 3D printed insoles, and shoes embedded 5-degree lateral wedges), (2) to build a detailed patient-specific knee model via MR images and musculoskeletal model, then, evaluate the compressive forces acting on the medial aspect of the knee during level walking and stair negotiation.
Read the detailed description
This study is a cross-sectional study with patients serving as their own control. The investigators will recruit 20 patients with knee osteoarthritis. Using motion capture system, force plates, wireless EMG to capture the motion data of patients during walking and stair negotiation in each condition.
- Conditions
- Medial Knee Osteoarthritis
- Being tested
- 3D-printed foot orthoses, 5 degrees lateral wedge insoles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-printed foot orthosesDevice
3D printed foot orthoses with arch support
5 degrees lateral wedge insolesDevice
Insoles with a lateral inclination set at 5 degrees
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis patients | Experimental | Not described Receives: Device: 3D-printed foot orthoses; Device: 5 degrees lateral wedge insoles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee adduction moment during level walking and stair negotiation
Surrogate marker of medial knee loading. Using motion capture system data to calculate the knee adduction moment via inverse dynamics method.
Measured: 10 minutes
Medial knee joint contact force during level walking and stair negotiation
Calculate the medial knee force to identify the change in medial knee loading by musculoskeletal model. The musculoskeletal model is driven by motion capture system data.
Measured: 10 minutes
Muscle co-activation ratio during level walking and stair negotiation
Level of muscle co-activation measured by electromyography (EMG).
Measured: 10 minutes
Secondary outcomes (3)
Knee flexion moment during level walking and stair negotiation
Surrogate marker of medial and lateral knee loading. Using motion capture system data to calculate the joint moments via inverse dynamics method. The calculated joint moments (N*m) will be normalized by multiplying body weight (Newton) and leg length (meter).
Measured: 10 minutes
Path of center of pressure during level walking and stair negotiation
The factor of affect the joint moments. Measured by force platform.
Measured: 10 minutes
Lower limbs joint angles during level walking and stair negotiation
Lower limbs alignment, including hip, knee and ankle joints. Using motion capture system data to calculate the joint angles.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start20 Apr 2019
- Primary completion26 Nov 2019
- Study completion10 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medial Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Far Eastern Memorial Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Wei Chou, PhD, Principal investigator, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843684
- Sponsor's protocol ID
- 108DN07
- Status last verified
- Feb 2019
- First submitted
- 12 Dec 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 3D-printed Insoles on Lower Extremity Biomechanics and Knee Joint Loading During Walking and Stair Climbing in Individuals With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03843684
- Acronym / sponsor ID
- 108DN07
- Conditions
- Medial Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Far Eastern Memorial Hospital
- Study start
- 20 Apr 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 10 Dec 2019 (actual)
- First posted
- 18 Feb 2019 (actual)
- 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 purposes of this study are: (1) to determine the kinematics, kinetics, and muscle co-activation ratio of level walking and stair negotiation under three different conditions (shoes only, shoes embedded 3D printed insoles, and shoes embedded 5-degree lateral wedges), (2) to build a detailed patient-specific knee model via MR images and musculoskeletal model, then, evaluate the compressive forces acting on the medial aspect of the knee during level walking and stair negotiation.
Detailed description
This study is a cross-sectional study with patients serving as their own control. The investigators will recruit 20 patients with knee osteoarthritis. Using motion capture system, force plates, wireless EMG to capture the motion data of patients during walking and stair negotiation in each condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis patients | Experimental | Device: 3D-printed foot orthoses, Device: 5 degrees lateral wedge insoles |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Medial knee OA (Kellgren-Lawrence grade I, II or III) according to clinical and radiological criteria of the American College of Rheumatology
- Aged from 50 to 70 years
Key exclusion criteria (7 listed)
- Neuromuscular illness (e.g., Parkinson disease, Neuropathy)
- Predominant lateral or patella-femoral OA
- Previous of planned hip or knee replacement
- Hip or ankle arthritis
- Rheumatoid arthritis
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 |
|---|---|---|
| 3D-printed foot orthoses3D printed foot orthoses with arch support | Device | Knee osteoarthritis patients |
| 5 degrees lateral wedge insolesInsoles with a lateral inclination set at 5 degrees | Device | Knee osteoarthritis patients |
Primary outcome
Knee adduction moment during level walking and stair negotiation
Time frame: 10 minutes
Surrogate marker of medial knee loading. Using motion capture system data to calculate the knee adduction moment via inverse dynamics method.
Medial knee joint contact force during level walking and stair negotiation
Time frame: 10 minutes
Calculate the medial knee force to identify the change in medial knee loading by musculoskeletal model. The musculoskeletal model is driven by motion capture system data.
Muscle co-activation ratio during level walking and stair negotiation
Time frame: 10 minutes
Level of muscle co-activation measured by electromyography (EMG).
3 secondary outcomes
Knee flexion moment during level walking and stair negotiation
Time frame: 10 minutes
Path of center of pressure during level walking and stair negotiation
Time frame: 10 minutes
Lower limbs joint angles during level walking and stair negotiation
Time frame: 10 minutes
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 Jan 2020.
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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.
Li-Wei Chou, PhD principal investigator
National Yang Ming Chiao Tung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-printed foot orthoses and 5 degrees lateral wedge insoles in people with Medial Knee Osteoarthritis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 2 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 13 Jan 2020. 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 Taiwan. 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?
Knee adduction moment during level walking and stair negotiation (time frame: 10 minutes). The study lists 3 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 13 Jan 2020.