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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-06

Study Completion Date

2019-03-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iovera° Device Treatment Group

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.

Group Type EXPERIMENTAL

iovera°

Intervention Type 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.

Standard of Care Treatment Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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iovera°

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.

Intervention Type DEVICE

Eligibility Criteria

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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.).

Minimum Eligible Age

22 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes