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Cryoneurolysis for Improvements in Pain, ADL and QOL in Patients With Ankle Osteoarthritis

Ankle Osteoarthritis Clinical Trial

Official title:
Cryoneurolysis for Improvements in Pain, Activities of Daily Living and Quality of Life in Patients With Ankle Osteoarthritis

Clinical Trial Summary

This will be an open-label trial to describe the effects of cryoneurolysis with iovera° on symptom relief in patients with painful Kellgren-Lawrence (KL) grade 2-4 ankle osteoarthritis (OA). The Foot and Ankle Outcome Score (FAOS) subscales will be used to assess outcomes at 6, 12 and 24 weeks after treatment.

Clinical Trial Description

The aim of this study is to assess clinically significant long-term symptomatic relief with cryoneurolysis in people with unilateral ankle osteoarthritis (OA). The investigators will treat 1) the Superficial Fibular Nerve (SFN), Sural Nerve (SN) and Saphenous Nerve and/or 2) the Deep Fibular Nerve (DFN) with cryoneurolysis using the iovera° device. The primary study endpoint, clinically significant improvement in pain 12 weeks after each treatment, will be assessed using the FAOS pain subscale. If a participant is a non-responder (<20% improvement in pain within the 12 weeks following baseline), then the other treatment will be offered (e.g. if start with superficial group, then offer the DFN). The secondary outcomes will be improvement in quality of life (FAOS-QoL), activities of daily living (FAOS-ADL) and Numerical Rating Scale (NRS) for pain. The tertiary outcome will be improvement in physical performance measures (40m fast-paced walking test, standing balance test). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03567187
Study type Interventional
Source University of Kansas Medical Center
Contact
Status Completed
Phase N/A
Start date July 3, 2018
Completion date January 28, 2021
View Details
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