Assessing if Cryoneurolysis Improves Prehabilitation and Decreases Pain After Surgery With Less Opioid Use in TKA Patients

NCT03836313 | Withdrawn FDA Device

• 1 other identifier: 2008P002629
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a prospective, randomized control trial to evaluate the impacts of preoperative cryoneurolysis treatment on opioid consumption with prehabilitation and resulting postoperative functional improvement in patients undergoing elective primary total knee arthroplasty (TKA).

Conditions

Arthropathy of Knee; Pain, Joint; Arthritis Knee; Opioid Use

Outcome Measures

Primary Outcomes (1)

• narcotic consumption after surgery

  determine if preoperative iovera° cryoneurolysis treatment with prehabilitation decreases opioid medication consumption based on morphine equivalents consumed within the first 4 weeks after surgery

  4 weeks

Secondary Outcomes (6)

• knee pain after surgery: Visual Analogue Scale (VAS) for pain

  3 months

• patient quadriceps strength

  3 months

• postoperative pain (measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS)).

  3 months

• patient discharge location after surgery (home versus rehabilitation or skilled nursing facilities)

  3 months

• general health and physical function (measured by Patient- Completed Health Outcomes Measurement Information System (PROMIS-10))

  3 months

Study Arms (2)

cryoneurolysis treatment

EXPERIMENTAL

TKA patients randomized to receive preoperative rehabilitation and cryoneurolysis treatment with the iovera° device (n=70)

Device: iovera°

no cryoneurolysis treatment (standard of care)

NO INTERVENTION

TKA patients randomized to receive preoperative rehabilitation only (no cryoneurolysis treatment) (n=70)

Interventions

iovera° DEVICE

Cryoneurolysis treatment using the iovera° device targeting the anterior femoral cutaneous nerve (AFCN) and the infrapatellar branch of the saphenous nerve (ISN) will occur approximately 4 weeks before surgery by a trained member of the study staff. Treatment will occur in clinic using suggested anatomical markings to target appropriate the AFCN and infrapatellar branch of the saphenous nerve (ISN) of the operative knee. The iovera° device contains three 27- gauge needles, all 6.9mm in length which will indent the subjects' skin and be inserted under the subcutaneous fat about 7 mm. Lidocaine will be used for superficial anesthetic at the treatment site before the needles puncture the patient's skin.There are a total of 9 iovera° cooling cycles. Treatment will be performed unilaterally and will be guided by visualization and palpation of anatomical landmarks.

cryoneurolysis treatment

Eligibility Criteria

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

You may qualify if:

• Subjects age \>= 18 years of age and undergoing elective unilateral primary total knee arthroplasty
• All subjects who are willing to comply with the requirements of the study and provide informed consent prior to enrollment. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study must be obtained before data collection.

You may not qualify if:

• Subjects that are undergoing bilateral TKA or revision TKA
• Pregnant women and vulnerable individuals.
• Patients who cannot undergo cryoneurolysis (i.e. Patients with cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, open/ infected wounds at or near the treatment site)

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Pacira Pharmaceuticals, Inc: collaborator

Related Publications (11)

• Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016 Jun;23(3):523-8. doi: 10.1016/j.knee.2016.01.011. Epub 2016 Feb 10.

  PMID: 26875052 RESULT

• Barnard D. The effects of extreme cold on sensory nerves. Ann R Coll Surg Engl. 1980 May;62(3):180-7.

  PMID: 7396346 RESULT

• Gabriel RA, Finneran JJ, Asokan D, Trescot AM, Sandhu NS, Ilfeld BM. Ultrasound-Guided Percutaneous Cryoneurolysis for Acute Pain Management: A Case Report. A A Case Rep. 2017 Sep 1;9(5):129-132. doi: 10.1213/XAA.0000000000000546.

  PMID: 28509777 RESULT

• Ilfeld BM, Gabriel RA, Trescot AM. Ultrasound-guided percutaneous cryoneurolysis providing postoperative analgesia lasting many weeks following a single administration: a replacement for continuous peripheral nerve blocks?: a case report. Korean J Anesthesiol. 2017 Oct;70(5):567-570. doi: 10.4097/kjae.2017.70.5.567. Epub 2017 Feb 3.

  PMID: 29046778 RESULT

• Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016 Aug;13(8):713-25. doi: 10.1080/17434440.2016.1204229. Epub 2016 Jul 13.

  PMID: 27333989 RESULT

• Inacio MCS, Paxton EW, Graves SE, Namba RS, Nemes S. Projected increase in total knee arthroplasty in the United States - an alternative projection model. Osteoarthritis Cartilage. 2017 Nov;25(11):1797-1803. doi: 10.1016/j.joca.2017.07.022. Epub 2017 Aug 8.

  PMID: 28801208 RESULT

• Pua YH, Ong PH. Association of early ambulation with length of stay and costs in total knee arthroplasty: retrospective cohort study. Am J Phys Med Rehabil. 2014 Nov;93(11):962-70. doi: 10.1097/PHM.0000000000000116.

  PMID: 24879549 RESULT

• Radnovich R, Scott D, Patel AT, Olson R, Dasa V, Segal N, Lane NE, Shrock K, Naranjo J, Darr K, Surowitz R, Choo J, Valadie A, Harrell R, Wei N, Metyas S. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017 Aug;25(8):1247-1256. doi: 10.1016/j.joca.2017.03.006. Epub 2017 Mar 20.

  PMID: 28336454 RESULT

• Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.

  PMID: 16880882 RESULT

• Zhou L, Kambin P, Casey KF, Bonner FJ, O'Brien E, Shao Z, Ou S. Mechanism research of cryoanalgesia. Neurol Res. 1995 Aug;17(4):307-11. doi: 10.1080/01616412.1995.11740333.

  PMID: 7477749 RESULT

• Zhou L, Shao Z, Ou S. Cryoanalgesia: electrophysiology at different temperatures. Cryobiology. 2003 Feb;46(1):26-32. doi: 10.1016/s0011-2240(02)00160-8.

  PMID: 12623025 RESULT

MeSH Terms

Conditions

Arthralgia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonia Chen, MD/MBA

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Antonia F. Chen, MD/MBA. Director of Arthroplasty Research, Principal Investigator,

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 11, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: June 1, 2021
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share