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Intra-Articular Catheter Total Knee Arthroplasty

NCT06580899 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Continuous Local Infiltration Analgesia
  • Intra-articular Catheter
  • Total Knee Arthroplasty

Interventions

DEVICE

Intra-articular catheter

Intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-op period

OTHER

Routine Standard of Care Treatment

No changes to what would occur outside of the study.

Sponsors & Collaborators

  • OrthoCarolina Research Institute, Inc.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2026-09-01
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580899 on ClinicalTrials.gov