Intra-Articular Catheter Total Knee Arthroplasty

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
OrthoCarolina Research Institute, Inc.
Study ID
NCT06580899
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intra-articular catheter — DEVICE
    Intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-op period
  • Routine Standard of Care Treatment — OTHER
    No changes to what would occur outside of the study.

Study Details

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.

Key Dates

Start date
Mar 14, 2025
Status verified
Mar 2026
Primary completion
Sep 1, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: No post-operative intra-articular catheter
    Subjects that receive ONLY the existing standard of care (SOC) multimodal pain management protocol and DO NOT receive post-operative intra-articular catheter.
  • Active Comparator: BRAND 1 intra-articular catheter
    Subjects that receive the BRAND 1 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period.
  • Active Comparator: BRAND 2 intra-articular catheter
    Subjects that receive the newer BRAND 2 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period.

Primary Outcome Measure

Numeric Pain Rating Scale [ Time Frame: 2 days postoperative, 2 weeks postoperative ]

Locations (1)

FacilityCityStateZIPSite coordinators
OrthoCarolina Research Institute, Inc.CharlotteNorth Carolina28207-

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