Osteoarthritis, KneeNCT03153956
Efficacy of AposTherapy® in Knee OA
A study testing Calibrated AposTherapy® in people with Osteoarthritis, Knee, run by NYU Langone Health at 1 site in United States.
Trial summary
A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in… Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Calibrated AposTherapy®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2015to 15 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months;
- Fulfilling the ACR clinical criteria;
- Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and,
- Having VAS-Pain ≥ 3, on a scale between 0-10.
- Patients who have a shoe size between US 4 and US 12
Who cannot join
- Patients suffering from acute septic arthritis.
- Patients who received a corticosteroid injection within 3 months of the study.
- Patients who received hyaluronic acid (HA) injections within 6 months of the study
- Patients suffering from avascular necrosis of the knee.
- Patients with a history of knee buckling or recent knee injury.
- Patients who have had a joint replacement or other major surgery to the knee, hip or ankle (ipsilateral or contralateral side).
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- Patients suffering from neuropathic arthropathy.
- Patients with an increased tendency to fall.
- Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
- Patients with a history of pathological osteoporotic fracture.
- Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees.
- Patients with referred pain in the knees from primary back or hip joint pain.
- Patients with neurological deficits to the lower extremity (ex. foot drop)
- Patients whose shoe size is less than US 4 and greater than US 12
- Patients who have had arthroscopy within 6 months of the study
- Patients with inflammatory arthropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis
A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).
- Conditions
- Osteoarthritis, Knee
- Being tested
- Calibrated AposTherapy®, Non-Calibrated Sham Apos Therapy Device
- Keywords
- AposTherapy® System, Osteoarthritis, Total knee arthroplasties, Degenerative joint disease
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calibrated AposTherapy®Device
a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.
Non-Calibrated Sham Apos Therapy DeviceDevice
The comparator group will receive a non-calibrated sham device.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment Arm | Experimental | Personally calibrated bio-mechanical device Receives: Device: Calibrated AposTherapy® |
| Control Arm | Placebo comparator | sham-placebo device (similar shoes without bio-mechanical elements). Receives: Device: Non-Calibrated Sham Apos Therapy Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster University (WOMAC) Total Score
WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Measured: screening, 3 months, 6 months, 9 months, and 12 months
Secondary outcomes (2)
Visual Analog Score (VAS) Score
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured.
Measured: 12 Months
Short-Form 36 (SF-36) Total Score
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The survey consists eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0-100, with lower scores = more disability and higher scores = less disability. Therefore, higher scores represent better health.
Measured: screening, 3 months, 6 months, 9 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start16 Apr 2015
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
Why it stopped: Halt in funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Model description
- Phase I - A prospective, interventional, randomized, double-arm clinical evaluation of patients who have been diagnosed with OA of the knee. The active treatment arm (personally calibrated biomechanical device) will be compared to a control arm (sham-placebo device) (similar shoes without biomechanical elements). Phase II - Open-label, cross-over study design. After the completion of phase one patients will be un-blinded to their group allocation. Patients that were allocated to the sham-placebo control group will cross to the active group and will receive the AposTherapy treatment. Patients that were allocated to the active group will continue with treatment.
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Cardone, DO, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153956
- Sponsor's protocol ID
- 14-02127
- Status last verified
- Mar 2020
- First submitted
- 9 May 2017
- Last updated
- 24 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Double-Armed Efficacy Evaluation of AposTherapy® for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03153956
- Acronym / sponsor ID
- 14-02127
- Conditions
- Osteoarthritis, Knee
- Keywords
- AposTherapy® System, Osteoarthritis, Total knee arthroplasties, Degenerative joint disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halt in funding
- Enrolment
- 77 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 16 Apr 2015 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, interventional, randomized, double-arm clinical evaluation study to examine the efficacy of AposTherapy® versus a control group, in the short-term at 6 months and in the long-term at 12 months post-treatment, with the primary efficacy assessment based on improvement in knee pain score and improvement in function in patients following diagnosis of knee osteoarthritis (OA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase I - A prospective, interventional, randomized, double-arm clinical evaluation of patients who have been diagnosed with OA of the knee. The active treatment arm (personally calibrated biomechanical device) will be compared to a control arm (sham-placebo device) (similar shoes without biomechanical elements). Phase II - Open-label, cross-over study design. After the completion of phase one patients will be un-blinded to their group allocation. Patients that were allocated to the sham-placebo control group will cross to the active group and will receive the AposTherapy treatment. Patients that were allocated to the active group will continue with treatment.
| Arm | Type | Receives |
|---|---|---|
| Active Treatment Arm | Experimental | Device: Calibrated AposTherapy®Personally calibrated bio-mechanical device |
| Control Arm | Placebo comparator | Device: Non-Calibrated Sham Apos Therapy Devicesham-placebo device (similar shoes without bio-mechanical elements). |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months;
- Fulfilling the ACR clinical criteria;
- Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and,
- Having VAS-Pain ≥ 3, on a scale between 0-10.
- Patients who have a shoe size between US 4 and US 12
Key exclusion criteria (16 listed)
- Patients suffering from acute septic arthritis.
- Patients who received a corticosteroid injection within 3 months of the study.
- Patients who received hyaluronic acid (HA) injections within 6 months of the study
- Patients suffering from avascular necrosis of the knee.
- Patients with a history of knee buckling or recent knee injury.
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 |
|---|---|---|
| Calibrated AposTherapy®a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology. | Device | Active Treatment Arm |
| Non-Calibrated Sham Apos Therapy DeviceThe comparator group will receive a non-calibrated sham device. | Device | Control Arm |
Primary outcome
Western Ontario and McMaster University (WOMAC) Total Score
Time frame: screening, 3 months, 6 months, 9 months, and 12 months
WOMAC evaluates the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. In this study, WOMAC scores were recomputed as the sum within sub-scales (pain score is the sum of questions 1-5; stiffness is the sum of questions 6-7; functional score is the sum of questions 8-24). The total score is reported as the sum of the pain, stiffness, and functional sub-scores for all participants. The total score range is 0-1292. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
2 secondary outcomes
Visual Analog Score (VAS) Score
Time frame: 12 Months
Short-Form 36 (SF-36) Total Score
Time frame: screening, 3 months, 6 months, 9 months, and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Dennis Cardone, DO principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calibrated AposTherapy® in people with Osteoarthritis, Knee, run by NYU Langone Health 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 16 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: stopped early, as of the sponsor's last update on 24 Mar 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 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?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Western Ontario and McMaster University (WOMAC) Total Score (time frame: screening, 3 months, 6 months, 9 months, and 12 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 24 Mar 2020.