Status:
ENROLLING_BY_INVITATION
Intra-Articular Catheter Total Knee Arthroplasty
Lead Sponsor:
OrthoCarolina Research Institute, Inc.
Conditions:
Continuous Local Infiltration Analgesia
Intra-articular Catheter
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a prospective, randomized clinical trial evaluating three groups. The groups are: Group 1 (Control): Subjects that receive only the existing standard-of-care multimodal pain management protoc...
Detailed Description
The purpose of this study is to determine the effects of one of two continuous local infiltration analgesia (intra-articular catheter device) on patient postoperative pain scores following primary uni...
Eligibility Criteria
Inclusion
- Patients undergoing elective outpatient unilateral TKA at Mallard Creek Surgery Center
- Subjects ≥ 18 years or age
- Subjects willing and able to provide written informed consent to participate in this study
- Subjects who are indicated to use an intra-articular catheter pump system
Exclusion
- Subjects \< 18 years of age
- Subjects with history of chronic pain, neuropathic pain, or currently enrolled in pain management agreement
- Subjects undergoing bilateral TKA
- Subjects taking opiate pain medication preoperatively within 6 weeks of surgery date.
- Subjects allergic to any components or treatment medications
Key Trial Info
Start Date :
March 14 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06580899
Start Date
March 14 2025
End Date
December 31 2026
Last Update
March 20 2025
Active Locations (1)
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1
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, United States, 28207