Osteoarthritis, KneeNCT02436590
Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee
A study testing Orthofix Physio-Stim Model 3315OA in people with Osteoarthritis, Knee, run by Orthofix Inc. at 2 sites in United States.
Trial summary
The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Orthofix Physio-Stim Model 3315OA
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to Sep 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be able to wear the investigational device so that there is adequate PEMF exposure to the knee.
- Subject must have a body mass index ≤ 45 at the time of consent.
- Subject must be at least forty (≥ 40) years of age of age at the time of consent.
- Subject must have an established diagnosis of primary femorotibial OA in the target knee by modified American College of Rheumatology criteria for at least 6 months and at least one of the following:
- Stiffness less than 30 min ii. Crepitus (noise or cracking on knee motion)
- Subject must have symptomatic Kellgren-Lawrence (K-L) Grades 1-3 OA by radiograph (PA flexion) within 90 days of screening, where the K-L grades are defined as:
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- Grade 1: doubtful narrowing of joint space and possible osteophytic lipping; Grade 2: definite osteophytes and definite narrowing of joint space; Grade 3: moderate multiple osteophytes and definite narrowing of joint space and some sclerosis and possible deformity of bone contour
- Subject must have a visual analog pain score between 4 cm and 8 cm on a 10 cm scale in the target knee at the time of screening.
- Subject must have a normal tibiofemoral angle (0-8°) and a joint space width of ≥ 3mm confirmed by radiograph.
- Subject must be ambulatory.
- Subject must NOT have had arthroscopy within 8 weeks of randomization.
- Subject must NOT have had viscosupplementation within 8 weeks of randomization.
- Subject must NOT have had NSAIDs within 1 week of randomization (low-dose aspirin as cardioprotective prophylaxis is permitted).
- Subject must be willing to discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics.
- Subject must be willing to take acetaminophen (up to 3000 mg/day) as pain medication for the duration of the study. Other pain medications may be allowed during the course of the study if the subject meets specific criteria.
- Subject must be willing to STOP taking any pain medications 24 hours prior any scheduled study visit.
- Subject must NOT have participated in a clinical study within the past 12 weeks that required the use of an investigational device, drug or biologic.
- Subjects must be proficient in English.
- Subject must be willing and able to sign an informed consent document.
- Subjects must be willing and able to comply with all study procedures for the duration of the clinical study.
Who cannot join
- Subjects who have a body mass index > 45 at the time of consent.
- Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint infection, Lyme disease, SLE, etc.).
- Subjects with a diagnosis of secondary arthritis (acromegaly, Charcot's arthropathy, hemochromatosis, Wilson's disease, ochronosis, etc.).
- Subjects with confounding factors such as ipsilateral hip OA or chronic pain syndromes (fibromyalgia, Crohn's disease, ulcerative colitis, interstitial cystitis).
- Subjects who have had an injury or an acute traumatic injury to the index knee within 6 months of screening will be excluded.
- Subjects who have had treatment of the target knee with intra-articular injections of steroids within 8 weeks of screening.
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- Subjects who have had intra-articular injections of hyaluronic acid within 8 weeks of screening.
- Subjects who plan to have surgery on the target knee within the study period.
- Subjects who have used electrotherapy or acupuncture for OA of the target knee within 4 weeks of screening.
- Subjects with significant and clinically evident mal-alignment of the target knee (> 10 degrees varus or valgus in the target knee).
- Subjects with surgical metallic hardware in the target knee.
- Subjects with pain in any other area of the lower extremities or back that is equal to or greater than the pain in the target knee.
- Subjects who have contraindications to MRI and X-rays, for example, implanted electrical devices (cardiac pacemakers, deep brain stimulators).
- Subjects with a current malignancy or who have received treatment for malignancy with the last 5 years, with the exception of resected basal cell carcinoma and squamous cell carcinoma of the skin.
- Subjects who have an active substance abuse problem (drugs or alcohol) or a history of chronic substance abuse (> 5 years).
- Subjects with skin breakdown or infection in the area where the study device will be placed.
- Subjects with any chronic conditions (e.g., diabetes, hypertension, congestive heart failure, etc.) that have not been well-controlled for at least 3 months prior to screening.
- Subjects who have any ongoing litigation for worker's compensation.
- Subjects with any condition, in the opinion of the Investigator that might interfere with the evaluation of the study objectives.
- Subjects who are unwilling or unable to adhere to the follow up schedule and procedures.
- Subjects who are pregnant.
- Subjects who are prisoners.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: A Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee
The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure.
Read the detailed description
The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure. The primary objective of this study is to prospectively determine, at 12 months post treatment, the safety and efficacy of treating OA of the knee with PEMF. Safety will be assessed through adverse event collection. Study subjects will be randomized in a 2:1 ratio (active: placebo control) to either an active or placebo control (inactive) Physio-Stim device. The study is powered to detect a significant difference between groups when 120 subjects (80 active: 40 placebo control) have completed the study. Planned enrollment for the study is 150 subjects, to allow for an attrition rate of 20%.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Orthofix Physio-Stim Model 3315OA
- Keywords
- osteoarthritis, knee, pulsed electromagnetic fields, PEMF
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthofix Physio-Stim Model 3315OADevice
Active device emits PEMF signal; placebo/control device does not emit PEMF signal
| Study group | Role | What they receive |
|---|---|---|
| Active PEMF | Active comparator | Subjects have a 2 out of 3 chance to get the active device which emits a Pulsed Electromagnetic Field (PEMF) from the Physio-Stim Model 3315OA device. Double blind randomization Receives: Device: Orthofix Physio-Stim Model 3315OA |
| Control/no PEMF | Placebo comparator | Subjects have a 1 out of 3 chance of getting the control/placebo device which does not emit Pulsed Electromagnetic Field (PEMF) from the Physio-Stim Model 3315A device. Double blind randomization Receives: Device: Orthofix Physio-Stim Model 3315OA |
What is being measured
The primary outcome is the main question the study is designed to answer.
change over time in WOMAC score
The primary outcome variables are a statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores and by a significantly increased number of study subjects achieving minimally clinical important differences (MCIDs).
Measured: 6 mo, 12 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orthofix Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roy K Aaron, MD, Principal investigator, Warren Alpert Medical School of Medicine, Brown University, Providence, Rhode IslandRonald Delanois, MD, Principal investigator, Rubin Institute for Advance Orthopedics, Sinai Hospital of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436590
- Sponsor's protocol ID
- CP-1403PSOA
- Status last verified
- Oct 2018
- First submitted
- 4 May 2015
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02436590
- Acronym / sponsor ID
- CP-1403PSOA
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, knee, pulsed electromagnetic fields, PEMF
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Orthofix Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 7 May 2015 (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 hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure.
Detailed description
The hypothesis of this study is that exposure to PEMF alters the cytokine environment of OA joints associated with a reduction of inflammation and improved homeostasis of the extracellular matrix (ECM), both potentially effecting symptomatic relief of OA pain, reducing cartilage breakdown, stimulate new cartilage formation therefore preserving joint structure. The primary objective of this study is to prospectively determine, at 12 months post treatment, the safety and efficacy of treating OA of the knee with PEMF. Safety will be assessed through adverse event collection. Study subjects will be randomized in a 2:1 ratio (active: placebo control) to either an active or placebo control (inactive) Physio-Stim device. The study is powered to detect a significant difference between groups when 120 subjects (80 active: 40 placebo control) have completed the study. Planned enrollment for the study is 150 subjects, to allow for an attrition rate of 20%.
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 |
|---|---|---|
| Active PEMF | Active comparator | Device: Orthofix Physio-Stim Model 3315OASubjects have a 2 out of 3 chance to get the active device which emits a Pulsed Electromagnetic Field (PEMF) from the Physio-Stim Model 3315OA device. Double blind randomization |
| Control/no PEMF | Placebo comparator | Device: Orthofix Physio-Stim Model 3315OASubjects have a 1 out of 3 chance of getting the control/placebo device which does not emit Pulsed Electromagnetic Field (PEMF) from the Physio-Stim Model 3315A device. Double blind randomization |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Subject must be able to wear the investigational device so that there is adequate PEMF exposure to the knee.
- Subject must have a body mass index ≤ 45 at the time of consent.
- Subject must be at least forty (≥ 40) years of age of age at the time of consent.
- Subject must have an established diagnosis of primary femorotibial OA in the target knee by modified American College of Rheumatology criteria for at least 6 months and at least one of the following:
- Subject must have symptomatic Kellgren-Lawrence (K-L) Grades 1-3 OA by radiograph (PA flexion) within 90 days of screening, where the K-L grades are defined as:
Key exclusion criteria (22 listed)
- Subjects who have a body mass index > 45 at the time of consent.
- Subjects with a diagnosis of inflammatory arthritis (rheumatoid arthritis, gout, joint infection, Lyme disease, SLE, etc.).
- Subjects with a diagnosis of secondary arthritis (acromegaly, Charcot's arthropathy, hemochromatosis, Wilson's disease, ochronosis, etc.).
- Subjects with confounding factors such as ipsilateral hip OA or chronic pain syndromes (fibromyalgia, Crohn's disease, ulcerative colitis, interstitial cystitis).
- Subjects who have had an injury or an acute traumatic injury to the index knee within 6 months of screening will be excluded.
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 |
|---|---|---|
| Orthofix Physio-Stim Model 3315OAActive device emits PEMF signal; placebo/control device does not emit PEMF signal | Device | Active PEMF, Control/no PEMF |
Primary outcome
change over time in WOMAC score
Time frame: 6 mo, 12 mo
The primary outcome variables are a statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores and by a significantly increased number of study subjects achieving minimally clinical important differences (MCIDs).
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 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.
Roy K Aaron, MD principal investigator
Warren Alpert Medical School of Medicine, Brown University, Providence, Rhode Island
Ronald Delanois, MD principal investigator
Rubin Institute for Advance Orthopedics, Sinai Hospital of Baltimore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthofix Physio-Stim Model 3315OA in people with Osteoarthritis, Knee, run by Orthofix Inc. at 2 sites 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 20 inclusion and 22 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study was stopped early. Results are not available in the source record.
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?
change over time in WOMAC score (time frame: 6 mo, 12 mo). 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 14 Jul 2020.