Intra-Articular Catheter Total Knee Arthroplasty

Effectiveness of Continuous Local Infiltration Analgesia Intra-Articular Catheters for Pain Relief in Total Knee Replacement

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Total Knee Arthroplasty; Continuous Local Infiltration Analgesia; Intra-articular Catheter
• Intervention / Treatment: Other: Routine Standard of Care Treatment; Device: Intra-articular catheter

Detailed Description

The purpose of this study is to determine the effects of one of two continuous local infiltration analgesia (intra-articular catheter device) on patient postoperative pain scores following primary unilateral total knee arthroplasty in comparison to no addition of an intra-articular (IART) catheter post total knee arthroplasty (TKA). The investigators hypothesize that if patients undergoing primary unilateral TKA surgery receive an intra-articular catheter device that continuously delivers local infiltration analgesia in the postoperative period, then their postoperative pain scores on the visual analog scale will decrease. Secondary objectives will include determining the role of intraoperative tourniquet use on thigh versus knee postoperative pain and quantifying the amount of additional postoperative patient communication related to the intra-articular catheter device.

Previous literature demonstrates conflicting results on the effects of continuous local infiltration analgesia on postoperative pain management following TKA. The proposed study incorporates a well-designed and substantially powered study to directly compare patient postoperative pain scores with and without the use of an intra-articular catheter device, which will provide additional evidence and clarity to the literature.

If the intra-articular catheter is determined to provide meaningful reductions in postoperative pain, this directly benefits patients undergoing TKA surgery. Decreases in postoperative pain allow for increased patient comfort and earlier functional knee rehabilitation following surgery, both of which promote a faster recovery. A favorable intra-articular catheter study, in addition to the previous literature on continuous local infiltration analgesia, has the potential to change the previous standard of care following TKA surgery to add intra-articular catheter or similar devices as an evidence-based treatment in multimodal pain protocols. If the intra-articular catheter is determined not to provide clinically significant reductions in postoperative pain, then these devices have no substantial benefit to the patient and orthopedic surgeons can stop prescribing them. TKA surgery would become more cost-effective as the additional cost associated with the intra-articular catheter device will no longer be charged. The intraarticular intra-articular catheter patient pump has a rare, but small risk of infection due to the portal from the external environment to the knee joint. This additional catheter infection risk will be eliminated if future use of the intra-articular catheter device subsides.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institute, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Routine Standard of Care Treatment; No changes to what would occur outside of the study.
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.	Device: Intra-articular catheter; Intra-articular catheter pump with existing standard-of-care 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.	Device: Intra-articular catheter; Intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-op period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Rating Scale	Numeric Pain Rating Scale (0-10 scale where 10 is worse)	2 days postoperative, 2 weeks postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)	KOOS Jr. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health	6 weeks postoperative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anesthesia Type	type of anesthesia used during procedure	at time of surgery
tourniquet times	how long was a tourniquet used during procedure	at time of surgery
range of motion	knee range of motion	preoperative, 2 weeks postoperative, 6 weeks postoperative

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 8, 2024
• First Submitted That Met QC Criteria: August 28, 2024
• First Posted (Actual): August 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: continuous local infiltration analgesia; intra-articular catheter
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Equipment and Supplies; Catheters
• Other Study ID Numbers: CONC005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes