Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial

Radnovich, Richard; Scott, David F.; Patel, Amit; Olson, Richard R.; Dasa, Vinod; Segal, Neil A.; Lane, Nancy E.; Shrock, K.; Naranjo, Julian; Darr, Kevin F; Surowitz, R.; Choo, Justin; Valadie, Arthur L.; Harrell, R. A.; Wei, Nathan; Metyas, Samy

doi:10.1016/j.joca.2017.03.006

Cited by 93 publications

(101 citation statements)

References 42 publications

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“…A two-arm randomised control trial 17 was conducted to study the efficacy and safety/tolerability of cryoneurolysis for reduction of pain and symptoms associated with mild to moderate knee osteoarthritis. The control treatment is sham.…”

Section: A Case Studymentioning

confidence: 99%

“…In Section 2, we describe the background and key elements of our decision-theoretic framework. In Section 3, we illustrate the optimal decision that is made based on stage one responses for a case study of a trial in osteoarthritis, 17 and the impact of prior distribution on the optimal decision. In Section 4, we illustrate the framework for an initial design that has (i) one treatment and a control arms, and (ii) two treatment and a control arms.…”

Section: Introductionmentioning

confidence: 99%

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To add or not to add a new treatment arm to a multiarm study: A decision‐theoretic framework

Lee

Wason

Stallard

2019

Statistics in Medicine

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Multiarm clinical trials, which compare several experimental treatments against control, are frequently recommended due to their efficiency gain. In practise, all potential treatments may not be ready to be tested in a phase II/III trial at the same time. It has become appealing to allow new treatment arms to be added into on‐going clinical trials using a “platform” trial approach. To the best of our knowledge, many aspects of when to add arms to an existing trial have not been explored in the literature. Most works on adding arm(s) assume that a new arm is opened whenever a new treatment becomes available. This strategy may prolong the overall duration of a study or cause reduction in marginal power for each hypothesis if the adaptation is not well accommodated. Within a two‐stage trial setting, we propose a decision‐theoretic framework to investigate when to add or not to add a new treatment arm based on the observed stage one treatment responses. To account for different prospect of multiarm studies, we define utility in two different ways; one for a trial that aims to maximise the number of rejected hypotheses; the other for a trial that would declare a success when at least one hypothesis is rejected from the study. Our framework shows that it is not always optimal to add a new treatment arm to an existing trial. We illustrate a case study by considering a completed trial on knee osteoarthritis.

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Section: A Case Studymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

To add or not to add a new treatment arm to a multiarm study: A decision‐theoretic framework

Lee

Wason

Stallard

2019

Statistics in Medicine

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“…18 Similarly, this blind approach using landmark techniques was used to treat nonsurgical pain associated with knee osteoarthritis. 33 In this randomized, doubleblind, sham-controlled multicenter study, the infrapatellar branch of the saphenous nerve was targeted with cryoneurolysis. The study population consisted of 180 patients, in which those in the treatment group had statistically significant decreases from baseline Western Ontario and McMaster Osteoarthritis Index (an instrument measuring functioning) and pain scores at 30, 60, and 90 days after treatment when compared with the control group.…”

Section: Application To Acute Painmentioning

confidence: 99%

Novel Methodologies in Regional Anesthesia for Knee Arthroplasty

Gabriel

2018

Anesthesiology Clinics

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Maximizing analgesia is critical following joint arthroplasty because postoperative pain is a major barrier to adequate physical therapy. Continuous peripheral nerve blocks have been the mainstay for acute pain management in this population; however, this and similar techniques are limited by their duration of action. Cryoneurolysis and peripheral nerve stimulation are two methodologies used for decades to treat chronic pain. With the advent of portable ultrasound devices and percutaneous administration equipment, both procedures may now be suitable for treatment of acute pain. This article reviews these two modalities and their application to joint arthroplasty.

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“…At the same time, the evolution of advanced imaging guidance and cryoablative technology has led to new percutaneous options for a variety of historically difficult‐to‐treat clinical conditions related to nerves . Specifically, cryoneurolysis (application of cold to nerves using small‐gauge, closed‐end needle systems) results in a well‐characterized, local, reversible nerve signaling attenuation that can be delivered as a single‐puncture outpatient procedure .…”

Section: Introductionmentioning

confidence: 99%

Percutaneous CT‐Guided Cryovagotomy in Patients with Class I or Class II Obesity: A Pilot Trial

Prologo

Lee

Bergquist

et al. 2019

Obesity

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Objective: This study evaluated the safety of percutaneous CT-guided cryoablation of the vagus nerve (percutaneous cryovagotomy) in participants with class I or class II obesity. Methods: The study was an open-label, single-group, prospective pilot investigation designed around safetyrelated stopping criteria. Twenty participants with 30 > BMI > 37 underwent percutaneous cryovagotomy with follow-up visits at day 7, 45, 90, and 180. Data related to adverse events, technical success, weight loss, quality of life, dietary intake, global impressions of hunger change, activity, and body composition were analyzed. Results: The procedural technical success rate was 100%. There were no adverse events in 19 participants who completed the trial. Ninety-five percent of patients reported decreased appetite following the procedure, and reductions in mean absolute weight and BMI were observed at all time points. The mean quality of life and activity scores improved from baseline to 6 months post procedure, and mean caloric intake and overall body fat decreased over the same period. Conclusions: Percutaneous CT-guided cryovagotomy is feasible and was tolerated without complications or adverse events in this cohort. Quantitative preliminary data from this pilot investigation inform the design of a larger prospective randomized clinical trial.

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Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial

Abstract: Cryoneurolysis of the IPBSN resulted in statistically significant decreased knee pain and improved symptoms compared to sham treatment for up to 150 days, and appeared safe and well tolerated.

Cited by 93 publications

References 42 publications

To add or not to add a new treatment arm to a multiarm study: A decision‐theoretic framework

To add or not to add a new treatment arm to a multiarm study: A decision‐theoretic framework

Novel Methodologies in Regional Anesthesia for Knee Arthroplasty

Percutaneous CT‐Guided Cryovagotomy in Patients with Class I or Class II Obesity: A Pilot Trial

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