Status:
WITHDRAWN
Assessing if Cryoneurolysis Improves Prehabilitation and Decreases Pain After Surgery With Less Opioid Use in TKA Patients
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Pacira Pharmaceuticals, Inc
Conditions:
Arthropathy of Knee
Pain, Joint
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective, randomized control trial to evaluate the impacts of preoperative cryoneurolysis treatment on opioid consumption with prehabilitation and resulting postoperative functional impro...
Detailed Description
Patients eligible for the study will be undergoing elective primary TKA at Brigham and Women's Hospital in Boston, MA. Study participants which meet the inclusion criteria listed above will be introdu...
Eligibility Criteria
Inclusion
- Subjects age \>= 18 years of age and undergoing elective unilateral primary total knee arthroplasty
- All subjects who are willing to comply with the requirements of the study and provide informed consent prior to enrollment. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study must be obtained before data collection.
Exclusion
- Subjects that are undergoing bilateral TKA or revision TKA
- Pregnant women and vulnerable individuals.
- Patients who cannot undergo cryoneurolysis (i.e. Patients with cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, open/ infected wounds at or near the treatment site)
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03836313
Start Date
March 1 2019
End Date
June 1 2021
Last Update
July 10 2019
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