Intra-Articular Catheter Total Knee Arthroplasty

NCT06580899 | Enrolling By Invitation Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: CONC005
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

continuous local infiltration analgesia; intra-articular catheter

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale

  Numeric Pain Rating Scale (0-10 scale where 10 is worse)

  2 days postoperative, 2 weeks postoperative

Secondary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)

  6 weeks postoperative

Other Outcomes (3)

• Anesthesia Type

  at time of surgery

• tourniquet times

  at time of surgery

• range of motion

  preoperative, 2 weeks postoperative, 6 weeks postoperative

Study Arms (3)

No post-operative intra-articular catheter

OTHER

Subjects that receive ONLY the existing standard of care (SOC) multimodal pain management protocol and DO NOT receive post-operative intra-articular catheter.

Other: Routine Standard of Care Treatment

BRAND 1 intra-articular catheter

ACTIVE COMPARATOR

Subjects that receive the BRAND 1 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period.

Device: Intra-articular catheter

BRAND 2 intra-articular catheter

ACTIVE COMPARATOR

Subjects that receive the newer BRAND 2 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period.

Device: Intra-articular catheter

Interventions

Intra-articular catheter DEVICE

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

BRAND 1 intra-articular catheter; BRAND 2 intra-articular catheter

Routine Standard of Care Treatment OTHER

No changes to what would occur outside of the study.

No post-operative intra-articular catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective outpatient unilateral TKA at Mallard Creek Surgery Center
• Subjects ≥ 18 years or age
• Subjects willing and able to provide written informed consent to participate in this study
• Subjects who are indicated to use an intra-articular catheter pump system

You may not qualify if:

• Subjects \< 18 years of age
• Subjects with history of chronic pain, neuropathic pain, or currently enrolled in pain management agreement
• Subjects undergoing bilateral TKA
• Subjects taking opiate pain medication preoperatively within 6 weeks of surgery date.
• Subjects allergic to any components or treatment medications

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Research Institute, Inc.

Charlotte, North Carolina, 28207, United States

Location

Related Publications (5)

• Gunaratne R, Pratt DN, Banda J, Fick DP, Khan RJK, Robertson BW. Patient Dissatisfaction Following Total Knee Arthroplasty: A Systematic Review of the Literature. J Arthroplasty. 2017 Dec;32(12):3854-3860. doi: 10.1016/j.arth.2017.07.021. Epub 2017 Jul 21.

  PMID: 28844632 BACKGROUND

• Li JW, Ma YS, Xiao LK. Postoperative Pain Management in Total Knee Arthroplasty. Orthop Surg. 2019 Oct;11(5):755-761. doi: 10.1111/os.12535.

  PMID: 31663286 BACKGROUND

• Horlocker TT. Pain management in total joint arthroplasty: a historical review. Orthopedics. 2010 Sep;33(9 Suppl):14-9. doi: 10.3928/01477447-20100722-65.

  PMID: 20839717 BACKGROUND

• Soffin EM, Memtsoudis SG. Anesthesia and analgesia for total knee arthroplasty. Minerva Anestesiol. 2018 Dec;84(12):1406-1412. doi: 10.23736/S0375-9393.18.12383-2. Epub 2018 May 28.

  PMID: 29808972 BACKGROUND

• Pugely AJ, Martin CT, Gao Y, Mendoza-Lattes S, Callaghan JJ. Differences in short-term complications between spinal and general anesthesia for primary total knee arthroplasty. J Bone Joint Surg Am. 2013 Feb 6;95(3):193-9. doi: 10.2106/JBJS.K.01682.

  PMID: 23269359 BACKGROUND

MeSH Terms

Interventions

Catheters

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 30, 2024
• Study Start: March 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)