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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 below

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days postoperative, 2 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

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.

0 / 4Eligibility criteria met