WithdrawnNot Applicable

Pain Control With Pre-operative Cryoneurolysis Following TKA

Stopped: Lost interest in study

United States0Started 2019-02-01

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Veterans Rand-12 (VR-12)

Timeframe: up to 3 months

Knee Injury and Osteoarthritis Outcomes Survey (KOOS Jr)

Timeframe: up to 3 months

Trial details

NCT IDNCT03818022

SponsorFondren Orthopedic Group L.L.P.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Osteo Arthritis Knee trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.