Intra-Articular Catheter Total Knee Arthroplasty

Launched by ORTHOCAROLINA RESEARCH INSTITUTE, INC. · Aug 28, 2024

Keywords

ClinConnect Summary

This is a Phase 4 clinical trial asking whether two different brands of a small pump that delivers pain medicine directly into the knee after total knee replacement can reduce pain more than standard care alone. Participants are randomly assigned to one of three groups: (1) standard pain care with no catheter, (2) standard care plus Brand 1 intra-articular catheter pump, or (3) standard care plus Brand 2 intra-articular catheter pump. The main measure is pain levels at about 2 days and 2 weeks after surgery, with knee function checked at 6 weeks. About 65 adults are expected to enroll at OrthoCarolina Research Institute in Charlotte, NC. The study started in March 2025 and is planned to finish in 2026, with results expected later in that period.

Who can join? Adults 18 and older undergoing outpatient, one-knee (unilateral) total knee replacement at Mallard Creek Surgery Center and who can give informed consent. They should not have used opioid pain medicines in the prior ~6 weeks and should not have a history of chronic pain or certain allergies. People having both knees replaced or who are under 18 are not eligible. If you participate, you may receive the catheter pump or standard care, but everyone will follow the same overall pain management plan. There is a very small risk of infection from the catheter. No results are available yet.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients undergoing elective outpatient unilateral TKA at Mallard Creek Surgery Center
• • 2. Subjects ≥ 18 years or age
• • 3. Subjects willing and able to provide written informed consent to participate in this study
• • 4. Subjects who are indicated to use an intra-articular catheter pump system
• Exclusion Criteria:
• • 1. Subjects \< 18 years of age
• • 2. Subjects with history of chronic pain, neuropathic pain, or currently enrolled in pain management agreement
• • 3. Subjects undergoing bilateral TKA
• • 4. Subjects taking opiate pain medication preoperatively within 6 weeks of surgery date.
• • 5. Subjects allergic to any components or treatment medications