Treatment With Iovera° for Total Knee Arthroplasty (TKA) Post-Operative Pain

NCT03327220 | Completed Results FDA Device

• 1 other identifier: MYO-1265
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate whether iovera° treatment prior to TKA decreases cumulative participant opioid use over the course of 6 weeks following TKA while maintaining similar levels of pain relief. The study will also investigate whether there is a relationship between participants treated with iovera° and participant reported pain and function as measured by knee injury and osteoarthritis outcomes score (KOOS JR), numeric rating scale (NRS) for pain; use of hospital services post-TKA and improved physical rehabilitation as measured by range of motion.

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• Cumulative Opioid Consumption

  The cumulative consumption of opioids was determined from the time of Total Knee Arthroplasty (TKA) surgery to 6 weeks post-TKA surgery. Opioid consumption was converted to morphine milligram equivalents (MME) and participant consumption was verified by pill count at follow-up visits. The cumulative morphine equivalent was divided by the number of days to provide the total daily morphine equivalent (TME) for the participant,

  From the time of TKA surgery to 6 weeks post-TKA surgery

Secondary Outcomes (3)

• Area Under the Curve (AUC)/Time for Change From Baseline in Knee Injury and Osteoarthritis Outcomes Score (KOOS JR.) Overall Score Through 6 Weeks Post-TKA

  Baseline to 6 weeks post-TKA surgery

• AUC/Time for Change From Baseline in Numeric Rating Scale (NRS) for Pain Through 6 Weeks Post-TKA

  Baseline to 6 weeks post-TKA surgery

• AUC/Time for Change From Baseline in Timed Get Up and Go (TUG) Tests Through 6 Weeks Post-TKA

  Baseline to 6 weeks post-TKA surgery

Study Arms (2)

iovera° Device Treatment Group

EXPERIMENTAL

Iovera° device presurgical cryoneurolysis treatment, 5 (+/- 2) days prior to TKA. Additionally, all participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.

Device: iovera°

Standard of Care Treatment Group

NO INTERVENTION

All participants received treatment as per all the standard pre-, peri-, and post-operative surgical protocols.

Interventions

iovera° DEVICE

The iovera° device applies cold to a target nerve to cause a temporary peripheral nerve block based on a process called Wallerian degeneration (2nd degree axonotmesis) without disrupting connective nerve tissue.

iovera° Device Treatment Group

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
• Participant is a class I-III on the American Society of Anesthesiology (ASA) Physical Classification System
• Anticipation of discharge to home after inpatient acute post-op phase based on age, co-morbidities, home environment, and social support are in favor of discharge to home in the opinion of the Investigator.
• Participant is willing and able to give written informed consent.
• Participant is fluent in verbal and written English.
• 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:

• 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 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 treatment.
• Previous Partial or Total Knee Arthroplasty. Partial or Total Knee Arthroplasty of the contralateral knee is permitted if surgery was completed at least nine (9) 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 (1)

Campbell Clinic

Germantown, Tennessee, 38138, United States

Location

Related Publications (1)

• Mihalko WM, Kerkhof AL, Ford MC, Crockarell JR Jr, Harkess JW, Guyton JL. Cryoneurolysis before Total Knee Arthroplasty in Patients With Severe Osteoarthritis for Reduction of Postoperative Pain and Opioid Use in a Single-Center Randomized Controlled Trial. J Arthroplasty. 2021 May;36(5):1590-1598. doi: 10.1016/j.arth.2020.11.013. Epub 2020 Nov 14.

  PMID: 33279353 DERIVED

Limitations and Caveats

This study was acquired from another sponsor. Results for the Primary Outcome Measure, Cumulative Opioid Consumption, are reported for the Time Frame (From the time of TKA surgery to 6 weeks post-TKA surgery) because the results for the Time Frame (From the time of hospital discharge to 6 weeks post-TKA surgery) are not available.

Results Point of Contact

• Title: Kent Jones/ Sr. Director, Quality and Medical Affairs
• Organization: Pacira CryoTech, Inc.

kent.jones@pacira.com

510-933-1513

Study Officials

• William Mihalko, MD, PhD

  UTHSC - COM - Orthopaedic Surgery & Biomedical Engineering

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The active group will receive the iovera° treatment prior to a TKA. The control group will receive a TKA and no iovera° treatment.

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 31, 2017
• Study Start: November 6, 2017
• Primary Completion: March 27, 2019
• Study Completion: March 27, 2019
• Last Updated: May 21, 2021
• Results First Posted: May 21, 2021

Record last verified: 2021-05

Locations

US (1)