Clinical trial NCT03327220: Treatment With Iovera° for Total Knee Arthroplasty (TKA) Post-Operative Pain
Official title: A Post-Market, Prospective, Randomized, Controlled Study To Evaluate The Iovera° Device In Treating Pain Associated With Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Knee Arthroplasty
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 124
Sex: ALL
Minimum age (years): 22
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The active group will receive the iovera° treatment prior to a TKA. The control group will receive a TKA and no iovera° treatment.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 22 to 79 years of age
2. Scheduled to undergo primary unilateral TKA under spinal anesthesia for primary diagnosis of osteoarthritis
3. Participant is a class I-III on the American Society of Anesthesiology (ASA) Physical Classification System
4. 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.
5. Participant is willing and able to give written informed consent.
6. Participant is fluent in verbal and written English.
7. Participant is willing and able to comply with study instructions and commit to all follow-up visits for the duration of the study.
8. 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:

1. Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months).
2. 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.).
3. Greater than 15° malalignment (varus or valgus) on pre-operative radiograph.
4. Previous Myoscience treatment.
5. 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.
6. Body Mass Index ≥ 40
7. 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.
8. 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.
9. Any local skin condition at the treatment sites that in the Investigator's opinion would adversely affect treatment or outcomes.
10. Open and/or infected wound in the treatment areas.
11. Allergy to lidocaine.
12. History of cryoglobulinemia
13. History of paroxysmal cold hemoglobinuria.
14. History of cold urticaria.
15. History of Raynaud's disease.
16. History of opioid or alcohol abuse.
17. Participant is pregnant or planning to become pregnant while enrolled in the study.
18. Current enrollment in any investigational drug or device study or participation within 30 days prior to screening.
19. Currently being treated for related knee injury under worker's compensation claim or equivalent (i.e. legal case).
20. Any chronic medical condition that in the Investigator's opinion would prevent adequate participation.
21. Any chronic medication use (prescription, over-the-counter, etc.) that in the Investigator's opinion would affect study participation or participant safety.
22. For any reason, in the opinion of the Investigator, the participant may not be a suitable candidate for study participation (i.e., history of noncompliance, drug dependency, etc.).

Primary outcomes:
measure: Cumulative Opioid Consumption
timeFrame: From the time of TKA surgery to 6 weeks post-TKA surgery
Secondary outcomes:
measure: 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
timeFrame: Baseline to 6 weeks post-TKA surgery
measure: AUC/Time for Change From Baseline in Numeric Rating Scale (NRS) for Pain Through 6 Weeks Post-TKA
timeFrame: Baseline to 6 weeks post-TKA surgery
measure: AUC/Time for Change From Baseline in Timed Get Up and Go (TUG) Tests Through 6 Weeks Post-TKA
timeFrame: Baseline to 6 weeks post-TKA surgery
Other outcomes:
Locations:
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
affiliation: UTHSC - COM - Orthopaedic Surgery & Biomedical Engineering
name: William Mihalko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.