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No post-operative intra-articular catheter for Total Knee Replacement

Phase 4
Waitlist Available
Research Sponsored by OrthoCarolina Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Patients undergoing elective outpatient unilateral TKA at Mallard Creek Surgery Center
2. Subjects ≥ 18 years or age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 2 weeks postoperative, 6 weeks postoperative
Awards & highlights

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 protocol and do not receive post-operative intra-articular catheter. Group 2 (Investigational Treatment/Intervention): Subjects that receive the brand 1 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period. Group 3 (Investigational Treatment/Intervention): Subjects that receive the newer brand 2 intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-operative period.

Who is the study for?
This trial is for individuals undergoing total knee replacement who can follow the post-operative pain management protocol. Specific eligibility details are not provided, but typically participants must meet certain health criteria and not have conditions that would exclude them from safely participating.
What is being tested?
The study compares three approaches to manage pain after knee surgery: standard care alone (Group 1), standard care plus a brand 1 intra-articular catheter pump (Group 2), and standard care with a newer brand 2 catheter pump (Group 3). Patients are randomly assigned to one of these groups.
What are the potential side effects?
While specific side effects aren't listed, intra-articular catheters may cause issues like infection at the insertion site, bleeding, or increased pain. Standard multimodal pain management protocols also carry risks such as nausea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks postoperative
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks postoperative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Numeric Pain Rating Scale
Secondary study objectives
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)
Other study objectives
Anesthesia Type
range of motion
tourniquet times

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: No post-operative intra-articular catheterExperimental Treatment1 Intervention
Subjects that receive ONLY the existing standard of care (SOC) multimodal pain management protocol and DO NOT receive post-operative intra-articular catheter.
Group II: BRAND 1 intra-articular catheterActive Control1 Intervention
Subjects that receive the BRAND 1 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period.
Group III: BRAND 2 intra-articular catheterActive Control1 Intervention
Subjects that receive the newer BRAND 2 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period.

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Who is running the clinical trial?

OrthoCarolina Research Institute, Inc.Lead Sponsor
35 Previous Clinical Trials
5,931 Total Patients Enrolled
~43 spots leftby Jun 2026
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