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Cryotherapy

Iovera for Osteoarthritis

N/A
Waitlist Available
Led By Neil A Segal, MD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change between baseline/screening and 24-weeks following treatment
Awards & highlights

Study 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.

Eligible Conditions
  • Osteoarthritis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between baseline/screening and 24-weeks following treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline/screening and 24-weeks following treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
FAOS - ADL(Activity of daily living)
FAOS - PAIN
FAOS-QoL(Quality of life)
Other outcome measures
40m fast paced walking test (40m FPWT)
Standing Balance Test

Trial Design

1Treatment groups
Experimental Treatment
Group I: IoveraExperimental Treatment1 Intervention
The iovera° device consists of a reusable, portable hand-piece, along with a single-patient use sterile smart Tip (cryoprobe) and disposable nitrous oxide (N2O) cartridges (cryogen). The smart tip is composed of closed-tip stainless steel needles, thereby fully enclosing the cryogen. There are 2 types of smart tips that will be utilized during this study, depending on the depth of the nerves being treated. The shorter smart tip comes in 2 variants - three X 6.9 mm or 8.9 mm, 27-gauge needles, with an attached skin warmer to prevent damage to the underlying skin. The longer smart tip also comes in 2 variants - 55 mm 22-gauge needle or a 90 mm 20G needle. The effect is by initiation of a cooling cycle, by fully inserting the smart tip into the procedure site and activating the cryogen flow. As the gas travels through the length of the needle, an ice ball develops around the needle freezing the surrounding tissue.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
iovera
2013
N/A
~90

Find a Location

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
462 Previous Clinical Trials
169,167 Total Patients Enrolled
5 Trials studying Osteoarthritis
785 Patients Enrolled for Osteoarthritis
Neil A Segal, MDPrincipal InvestigatorUniversity of Kansas Medical Center
5 Previous Clinical Trials
226 Total Patients Enrolled
4 Trials studying Osteoarthritis
154 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Arkansas
How old are they?
18 - 65
What site did they apply to?
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
Osteoarthritis and CartilageJournal
OARSI Recommended Performance-based Tests to Assess Physical Function in People Diagnosed with Hip or Knee Osteoarthritis
Dobson, F., R.S. Hinman, E.M. Roos, J.H. Abbott, P. Stratford, A.M. Davis, R. Buchbinder, et al.. 2013. “OARSI Recommended Performance-based Tests to Assess Physical Function in People Diagnosed with Hip or Knee Osteoarthritis”. Osteoarthritis and Cartilage. Elsevier BV. doi:10.1016/j.joca.2013.05.002.
clinicaltrials.govStudy
Cryoneurolysis for Improvements in Pain, ADL and QOL in Patients With Ankle Osteoarthritis
Neil Segal, MD, MS 2018. "Cryoneurolysis for Improvements in Pain, ADL and QOL in Patients With Ankle Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03567187.
All > Oa
~6 spots leftby Apr 2025
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