Pain Control With Pre-operative Cryoneurolysis Following TKA

Osteo Arthritis Knee Clinical Trial

Official title:

Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03818022
• Other study ID #: TOH180
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: December 2020

Study information

• Verified date: February 2024
• Source: Fondren Orthopedic Group L.L.P.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the potential benefit of preoperative cryoneurolysis in postoperative pain management of total knee arthroplasty patients over current pain management protocol.

Description:

Cryoneurolysis, is a novel technique that can yield temporary blockade of superficial sensory nerves, generating immediate and meaningful relief of pain.The technique generates an axonotmesis of the targeted peripheral nerves by percutaneously applying low temperatures (-100 °C to -20 °C). Wallerian degeneration is produced whereby the axons and the myelin sheath are damaged but the endoneurium, perineurium and epineurium remain intact. Therefore, permanent damage to the nerve is avoided as it retains its regenerative properties. With regards to the knee, the infrapatellar branch of the saphenous nerve (IPBSN), a sensory branch serving both the inferior and anterior portion of the knee capsule and the antero-medial skin of the knee is the prime target for the procedure.

Your participation in this study requires that you allow the radiology department of Texas Orthopedic Hospital to administer Cryoneurolysis using the Iovera device with the functional smart tip approximately 1 week prior to total knee arthroplasty surgery. A highly localized cold zone is created via the Joule-Thompson effect as nitrous oxide enters the needles. Nothing is injected into the body and the nitrous oxide gas is vented safely out of the handpiece. Cryoneurolysis is administered following local anesthesia.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• any patient scheduled for primary total knee arthroplasty(TKA)

Exclusion Criteria:

• Bilateral TKA (patients routinely receive spinal anesthesia)

• Minors

• Patients reporting a history of Raynaud's disease

• Patients with an open and/or infected wound on surgical knee

• Patients who are taking opioids during the pre-operative period due to knee pain

• Patients who cannot return for the cryoneurolysis treatment 7 days prior to surgery or post-operative clinical visits

• Patients whose insurance would deny payment for the cryoneurolysis treatment

• Pregnant patients

• Patients unable to speak and read English

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Procedure:
• Cryoneurolysis (Iovera)
Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty

Locations

Country	Name	City	State
United States	Fondren Orthopedic Group, L.L.P.	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Fondren Orthopedic Group L.L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Veterans Rand-12 (VR-12)	VR-12 is a 12 item questionnaire that measures health related quality of life. Scores range from 0 to 100 with 50 being an average score and higher scores representing better health related quality of life.	up to 3 months
Primary	Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)	KOOS Jr. is a short questionnaire that evaluates knee pain and function. Scores range from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.	up to 3 months
Secondary	Number of subject with an adverse effect from treatment	Any complication during treatment will be recorded.	up to 3 months
Secondary	Range of motion	During clinical office visits, your ability to bend and straighten your knee will be recorded.	up to 3 months
Secondary	Knee function	During clinical office visits, your ability to perform daily activities with regards to your knee will be recorded.	up to 3 months
Secondary	Knee swelling	The amount of swelling in your knee will be recorded.	up to 3 months