Intra-Articular Catheter for Total Knee Replacement

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: OrthoCarolina Research Institute, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for a knee replacement surgery at Mallard Creek Surgery Center.

I am 18 years old or older.

Exclusion Criteria

I am having both of my knees replaced.

I am under 18 years old.

Participant Groups

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.

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.