Study to Evaluate the Iovera° Device for Temporary Relief From Knee Pain

Completed · Not applicable · Has a placebo group

Conditions studied: Knee Osteoarthritis

In brief

This purpose of this study is to evaluate the effectiveness and safety of the iovera° device for the temporary reduction of pain associated with knee osteoarthritis.

Key facts

Study ID: NCT02260921
Run by: Pacira Pharmaceuticals, Inc
People needed: 180
Starts: 2014-10-20
Expected to finish: 2016-05-31
Last updated by the study team: 2024-01-24

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

35 - 75 years of age
American College of Rheumatology (ACR) criteria for osteoarthritis of the knee. This includes radiographic evidence of osteophytes and at least one of the following: age ≥ 50 years old, morning stiffness ≤ 30 minute duration or crepitus on motion.
Grade II or III osteoarthritis of the knee as determined by Kellgren-Lawrence classification grading scale on anteroposterior (AP) x-ray within previous 6 months.
Participants are ambulatory without assistive devices.
Knee pain of ≥ 40 mm on Visual Analog Scale (VAS) when performing one of two movements that elicit the worst pain: standing from a seated position or walking up/down stairs.
Participant reports knee pain in the anterior and/or inferior aspect of the knee as documented on the knee pain map in the appropriate areas.
A diagnostic lidocaine (without epinephrine) block of the infrapatellar branch of the saphenous nerve results in a 50% reduction in the VAS pain assessment score when performing the activity that elicits the worst pain: standing from a seated position or walking up/down stairs.
Participant is able to tolerate a washout of prescription and over-the-counter pain relief for a duration of 5 times the half-life of the medication prior to the Baseline visit.
Participant is able to tolerate a washout of adjunctive therapies for knee pain for 72 hours prior to the Baseline visit.
Western Ontario and McMaster Osteoarthritis Index (WOMAC) NRS3.1 Pain subscore ≥ 20 at Baseline/Visit 2.
Participant is able to tolerate discontinuation of all pain medication throughout the duration of the study. Acetaminophen may be used as rescue medication with a maximum dose of 4g per day.
Participant is able to tolerate discontinuation of rescue medication, acetaminophen, for 24 hours prior to all follow-up visits.
Prescription and over-the-counter pain medications must be maintained on a stable schedule for at least two weeks prior to screening.
Participant is willing and able to give written informed consent.
Participant is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
Participant is in good general health and free of any systemic disease state or physical condition that might impair evaluation or which in the Investigator's opinion, exposes the Participant to an unacceptable risk by study participation.

You may not qualify if…

History of a partial or full knee replacement of the knee to be treated.
Planned partial or full knee replacement within the next 12 months in knee to be treated.
Previous myoscience Focused Cold Therapy\^TM (FCTTM) treatment.
Viscosupplementation within the previous 6 months in knee to be treated.
Participant reports the majority of knee pain outside of the anterior/inferior aspect of the knee.
Intra-articular steroid injection in the knee to be treated within previous 3 months.
Gross deformity of the knee including varus or valgus.
Started physical therapy of the knee to be treated within 3 months of screening.
Received acupuncture for knee pain within 3 months prior to screening.
Body Mass Index ≥ 35.
Prior surgery in the treatment area that may alter the anatomy of the infrapatellar branch of the saphenous nerve or result in scar tissue in the treatment area.
Open and/or infected wound in the treatment area.
Disease of the spine, hip, contralateral knee or other lower extremity joint of sufficient degree affecting the assessment of the treated knee.
Acetaminophen intolerance or allergy.
Allergy to lidocaine.
History of cryoglobulinemia
History of paroxysmal cold hemoglobinuria.
History of cold urticaria.
History of Raynaud's disease.
History of pes anserinus bursitis in the knee to be treated.
Use of extended-release or long-acting opioids within previous 3 months.
Use of immediate-release opioids for more than 3 days per week within previous month.
Participant is pregnant or planning to become pregnant while enrolled in the study.
Current enrollment in any investigational drug or device study or participation within 30 days prior to screening.
Any additional diagnosis that in the opinion of the Investigator directly contributes to knee pain.

Where it is running

Medvin Clinical Research — Covina, California, United States
UC Davis Center for Musculoskeletal Health — Sacramento, California, United States
Coastal Orthopedics and Sports Medicine of Southwest Florida, PA — Bradenton, Florida, United States
Shrock Orthpedic Research — Fort Lauderdale, Florida, United States
Health Awareness — Jupiter, Florida, United States
JM Clinical Research — South Miami, Florida, United States
Injury Care Medical Center — Boise, Idaho, United States
Rockford Orthopedic Associates, LTD — Rockford, Illinois, United States
Kansas University Medical Center — Fairway, Kansas, United States
Kansas City Bone and Joint Clinic — Overland Park, Kansas, United States
Covington Orthopedic and Sports Medicine Institute — Covington, Louisiana, United States
LHU HSC Department of Orthopaedics — New Orleans, Louisiana, United States
Arthritis Treatment Center — Frederick, Maryland, United States
Triangle Orthopaedic Associates, P.A. — Durham, North Carolina, United States
Blair Orthopedic Associates, Inc. — Altoona, Pennsylvania, United States
PCET Research Center — Knoxville, Tennessee, United States
Spokane Joint Replacement Center — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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