Clinical trial NCT02260921: Study to Evaluate the Iovera° Device for Temporary Relief From Knee Pain
Official title: A Multi-Center, Prospective, Double-Blind, Randomized Controlled Study to Evaluate the Effectiveness and Safety of the Iovera° Device for the Temporary Relief of Pain Associated With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2014-10-09
Enrollment: 180
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Any concomitant inflammatory disease or other condition that affects the joints (e.g. rheumatoid arthritis, metabolic bone disease, gout, active infection, etc.)
* Any clotting disorder and/or use of an anticoagulant (e.g., aspirin, warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device.
* Any local skin condition at the treatment site that in the Investigator's opinion would adversely affect treatment or outcomes.
* Any chronic medical condition that in the Investigator's opinion would prevent adequate participation.
* Any chronic medication use (prescription, over-the-counter, etc.) that in the Investigator's opinion would affect study participation or Subject safety.
* For any reason, in the opinion of the Investigator, the Subject may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, any related knee injury due to a worker's compensation claim, etc.).
* Known liver dysfunction.

Primary outcomes:
measure: Absolute Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale Score at Day 30
timeFrame: Baseline to Day 30
Secondary outcomes:
measure: Change From Baseline in Visual Analog Scale (VAS) at Day 30
timeFrame: Baseline to Day 30
measure: Change From Baseline in Total WOMAC Score at Day 30
timeFrame: Baseline to Day 30
measure: Change From Baseline in VAS at Day 60
timeFrame: Baseline to Day 60
measure: WOMAC Pain Score Responder Rate at Day 30
timeFrame: Day 30
measure: VAS Responder Rate at Day 30
timeFrame: Day 30
measure: Change From Baseline in Total WOMAC Score at Day 60
timeFrame: Baseline to Day 60
measure: VAS Responder Rate at Day 60
timeFrame: Day 60
measure: WOMAC Pain Score Responder Rate at Day 60
timeFrame: Day 60
Other outcomes:
Locations:
city: Covina
country: United States
facility: Medvin Clinical Research
state: California
city: Sacramento
country: United States
facility: UC Davis Center for Musculoskeletal Health
state: California
city: Bradenton
country: United States
facility: Coastal Orthopedics and Sports Medicine of Southwest Florida, PA
state: Florida
city: Fort Lauderdale
country: United States
facility: Shrock Orthpedic Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness
state: Florida
city: South Miami
country: United States
facility: JM Clinical Research
state: Florida
city: Boise
country: United States
facility: Injury Care Medical Center
state: Idaho
city: Rockford
country: United States
facility: Rockford Orthopedic Associates, LTD
state: Illinois
city: Fairway
country: United States
facility: Kansas University Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Kansas City Bone and Joint Clinic
state: Kansas
city: Covington
country: United States
facility: Covington Orthopedic and Sports Medicine Institute
state: Louisiana
city: New Orleans
country: United States
facility: LHU HSC Department of Orthopaedics
state: Louisiana
city: Frederick
country: United States
facility: Arthritis Treatment Center
state: Maryland
city: Durham
country: United States
facility: Triangle Orthopaedic Associates, P.A.
state: North Carolina
city: Altoona
country: United States
facility: Blair Orthopedic Associates, Inc.
state: Pennsylvania
city: Knoxville
country: United States
facility: PCET Research Center
state: Tennessee
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
References:
citation: Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.