A Randomized, Study to Evaluate the Iovera° Device in Treating Pain Associated With Total Knee Arthroplasty

NCT02284113 | Completed Results

• 1 other identifier: MYO-1070
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 8

Brief Summary

This study will evaluate the iovera° device in treating pain associated with total knee arthroplasty (TKA). This study will also assess if overall pain medication is reduced following TKA and will investigate the relationship between patients treated with the iovera° device and length of hospital stay, pain, patient satisfaction and improved rehabilitation.

Conditions

Arthritis of the Knee

Outcome Measures

Primary Outcomes (1)

• Cumulative Consumption of Opioids Total Daily Morphine Equivalent (TME) (mg/Day)

  The cumulative morphine equivalent was divided by the number of days to provide a Total Daily Morphine Equivalent (TME) for each Subject.

  hospital discharge to 6 Weeks post-TKA surgery

Secondary Outcomes (8)

• Change in Pain From Baseline to Six Weeks

  Baseline to 6 Weeks

• Change in WOMAC Scores at 6 Weeks After Surgery

  Baseline to 6 weeks after surgery

• Length of Hospital Stay

  treatment to hospital discharge

• Change in Active Range of Motion From Baseline to 2 Weeks After Surgery

  baseline to 2 weeks after surgery

• 40 Meter Walk Test

  Baseline, 2,4,6,12 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Treatment with focused cold therapy.

Device: iovera°

Sham

SHAM COMPARATOR

Sham treatment with focused cold therapy device

Device: iovera° Sham

Interventions

iovera° DEVICE

Use of iovera° device to administer treatment Focused Cold Therapy

Treatment

iovera° Sham DEVICE

iovera° device used for sham treatment

Sham

Eligibility Criteria

• Age: 22 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 79 years of age
• Scheduled to undergo primary unilateral TKA under spinal anesthesia for primary diagnosis of osteoarthritis
• American Society of Anesthesiology (ASA) Physical Classification System classes I-III
• Anticipation of discharge to home after inpatient acute post-op phase (age, co-morbidities, home environment, and social support are in favor of discharge to home in the opinion of the Investigator)
• Subject is willing and able to give written informed consent.
• Subject is fluent in verbal and written English.
• Subject is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
• Subject 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 Subject to an unacceptable risk by study participation.

You may not qualify if:

• Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months).
• Concurrent painful physical condition, surgery, or musculoskeletal disease that requires or may require analgesic treatment during study follow-up that is not strictly related to the target knee being treated with iovera°, which have the potential to confound the postoperative assessments (e.g., significant pain from other joints, chronic neuropathic pain, concurrent or planned contralateral TKA, concurrent foot, neck, spine, hip, or other musculoskeletal disease, arthritis, or planned surgery, etc.).
• Greater than 15° malalignment (varus or valgus) on pre-operative radiograph.
• Previous myoscience FCT™ treatment.
• Previous Partial or Total Knee Arthroplasty. Partial or Total Knee Arthroplasty of the contralateral knee is permitted if \[surgery was completed at least twelve (12) months prior to screening\].
• Body Mass Index ≥ 40
• Prior surgery in the treatment areas that may alter the anatomy of the infrapatellar branch of the saphenous nerve (ISN) or the anterior femoral cutaneous nerve (AFCN) or result in scar tissue in the treatment area.
• Any clotting disorder and/or use of an anticoagulant (e.g. warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device. Low dose aspirin (81mg or less daily) for cardiac prophylaxis allowed.
• Any local skin condition at the treatment sites that in the Investigator's opinion would adversely affect treatment or outcomes.
• Open and/or infected wound in the treatment areas.
• Allergy to lidocaine.
• History of cryoglobulinemia
• History of paroxysmal cold hemoglobinuria.
• History of cold urticaria.
• History of Raynaud's disease.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (8)

University of California San Diego

San Diego, California, 92130, United States

Location

Colorado Orthopedic Consultants, P.C.

Englewood, Colorado, 80110, United States

Location

Holy Cross Hospital Orthopedic Research Institute

Fort Lauderdale, Florida, 33334, United States

Location

Phoenix Clinical Research, LLC

Tamarac, Florida, 33321, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

LSUHSC - Department of Orthopaedics

New Orleans, Louisiana, 70112, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Results Point of Contact

• Title: Medical Information
• Organization: Pacira Pharmaceuticals, Inc.

MedInfo@Pacira.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: November 3, 2014
• First Posted: November 5, 2014
• Study Start: December 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: January 24, 2024
• Results First Posted: July 27, 2023

Record last verified: 2024-01

Locations

US (8)