Efficacy and Safety of an Active Pulsed Electromagnetic Field for the Treatment of Osteoarthritis of the Knee

NCT02436590 | Terminated

• 1 other identifier: CP-1403PSOA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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 formation therefore preserving joint structure.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; knee; pulsed electromagnetic fields; PEMF

Outcome Measures

Primary Outcomes (1)

• 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).

  6 mo, 12 mo

Study Arms (2)

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

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

Device: Orthofix Physio-Stim Model 3315OA

Interventions

Orthofix Physio-Stim Model 3315OA DEVICE

Active device emits PEMF signal; placebo/control device does not emit PEMF signal

Active PEMF; Control/no PEMF

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• i. 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:
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Orthofix Inc.: lead

Study Sites (2)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Roy K Aaron, MD

  Warren Alpert Medical School of Medicine, Brown University, Providence, Rhode Island

  PRINCIPAL INVESTIGATOR

• Ronald Delanois, MD

  Rubin Institute for Advance Orthopedics, Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 7, 2015
• Study Start: January 1, 2016
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: July 14, 2020

Record last verified: 2018-10

Locations

US (2)