Study Stopped
Lost interest in study
Pain Control With Pre-operative Cryoneurolysis Following TKA
Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty
1 other identifier
interventional
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2019
CompletedFirst Posted
Study publicly available on registry
January 28, 2019
CompletedStudy Start
First participant enrolled
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 23, 2024
February 1, 2024
1.8 years
January 9, 2019
February 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (4)
Number of subject with an adverse effect from treatment
up to 3 months
Range of motion
up to 3 months
Knee function
up to 3 months
Knee swelling
up to 3 months
Study Arms (2)
Experimental
EXPERIMENTALPatients receiving Cryoneurolysis (Iovera) prior to total knee arthroplasty
Control
NO INTERVENTIONInterventions
Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty
Eligibility Criteria
You may qualify if:
- any patient scheduled for primary total knee arthroplasty(TKA)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondren Orthopedic Group, L.L.P.
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2019
First Posted
January 28, 2019
Study Start
February 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 23, 2024
Record last verified: 2024-02