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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02260921
• Other study ID #: MYO-0946
• Status: Completed
• Phase: N/A
• Start date: October 20, 2014
• Est. completion date: May 31, 2016

Study information

• Verified date: January 2024
• Source: Pacira Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 31, 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• iovera°

• Sham Comparator

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pacira Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline in Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain Subscale Score at Day 30	The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. A negative change from Baseline indicates improvement. An Analysis of Covariance (ANCOVA) model was used for analyses.	Baseline to Day 30
Secondary	Change From Baseline in Visual Analog Scale (VAS) at Day 30	VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 centimeter (cm) [100 millimeter (mm)] horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain". A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.	Baseline to Day 30
Secondary	Change From Baseline in Total WOMAC Score at Day 30	The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. The WOMAC total score was calculated by summing the 3 subscales for a total possible score of 0 to 240. A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.	Baseline to Day 30
Secondary	Change From Baseline in VAS at Day 60	VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain". A negative change from Baseline indicates improvement. An ANCOVA model was used for analyses.	Baseline to Day 60
Secondary	WOMAC Pain Score Responder Rate at Day 30	WOMAC Pain Score Responder Rate is defined as the percentage of participants with at least a 30% reduction in the WOMAC pain score at Day 30 compared to Baseline. WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No to 10= Extreme] with the first 5 questions regarding pain [possible subscale score 0 (best) to 50 (worst)].	Day 30
Secondary	VAS Responder Rate at Day 30	VAS Responder Rate is defined as the percentage of participants with at least a 30% reduction in VAS at Day 30 compared to Baseline VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain".	Day 30
Secondary	Change From Baseline in Total WOMAC Score at Day 60	The WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with 5 questions regarding pain [possible subscale score 0 to 50], 2 questions regarding stiffness [possible subscale score 0 to 20] and 17 questions regarding function difficulty [possible subscale score 0 to 170]. The WOMAC total score was calculated by summing the 3 subscales for a total possible score of 0 to 240. A negative change from Baseline indicates improvement.	Baseline to Day 60
Secondary	VAS Responder Rate at Day 60	VAS Responder Rate is defined as the percentage of participants with at least a 30% reduction in VAS at Day 60 compared to Baseline. VAS pain assessment is a measure of pain intensity. The scale is made up of a 10 cm (100 mm) horizontal line. The far left of the horizontal line is labeled "no pain" while the far right of the horizontal line is labeled "worst imaginable pain".	Day 60
Secondary	WOMAC Pain Score Responder Rate at Day 60	WOMAC Pain Score Responder Rate is defined as the percentage of participants with at least a 30% reduction in the WOMAC pain score at Day 60 compared to Baseline. WOMAC is a tri-dimensional, disease-specific, patient-reported outcome measure. It consists of 24 questions [each question is presented in a numerical rating scale format with possible values between 0= No (best) to 10= Extreme (worst)] with the first 5 questions regarding pain [possible subscale score 0 to 50].	Day 60