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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
Patients undergoing elective outpatient unilateral TKA at Mallard Creek Surgery Center
Subjects ≥ 18 years of age
Must not have
Subjects undergoing bilateral TKA
Subjects < 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up preoperative, 2 weeks postoperative, 6 weeks postoperative
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial is looking at three different groups of people who have just had surgery. - Group 1 (Control): These people will get the regular pain management treatment after surgery, but they won't
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 belowSelect...
I am scheduled for a knee replacement surgery at Mallard Creek Surgery Center.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am having both of my knees replaced.
Select...
I am under 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days postoperative, 2 weeks postoperative
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days postoperative, 2 weeks postoperative
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
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Find a Location
Who is running the clinical trial?
OrthoCarolina Research Institute, Inc.Lead Sponsor
36 Previous Clinical Trials
5,981 Total Patients Enrolled