Intra-Articular Catheter for Total Knee Replacement

Overseen By Caleb J Michalek, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: OrthoCarolina Research Institute, Inc.

Must not be taking: Opiate pain medications

Disqualifiers: Chronic pain, Neuropathic pain, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods for managing pain after knee replacement surgery. Researchers aim to compare the effectiveness of two types of intra-articular catheter pumps, which deliver pain relief directly to the joint, against standard pain management methods. The study includes three groups: one receiving standard pain care and two using different catheter pumps. It seeks participants undergoing single knee replacement surgery who have not recently used opiate pain medications and do not have chronic pain issues. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have taken opiate pain medication within 6 weeks before surgery.

What is the safety track record for the intra-articular catheter treatments?

Research shows that using catheters inside the joint, similar to those in knee replacement surgeries, can reduce pain by delivering medicine directly to the area. This applies to both the brand 1 and brand 2 catheters under study. Studies have found that bupivacaine, a common pain medicine used in these catheters, effectively manages pain without increasing side effects.

However, some concerns about risks exist. For instance, some sources mention a possible increased risk of deep infections with these catheters. Despite this, the overall risk of infection in similar surgeries remains low, about 1 in 14,000 to 15,000 cases.

Since this trial is in Phase 4, substantial safety information is already available. Treatments in this phase are usually well-tolerated. Nonetheless, discussing potential risks and benefits with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using intra-articular catheters for pain management in total knee replacement surgeries because these devices deliver pain relief directly to the surgical site. This is different from traditional methods that rely on oral or intravenous painkillers, which can affect the whole body and potentially cause side effects. The BRAND 1 catheter integrates with existing pain management protocols, offering a targeted approach, while the newer BRAND 2 catheter might provide even more effective pain relief with its advanced delivery system. By focusing on localized pain control, these catheters could improve recovery times and reduce the need for systemic medications.

What evidence suggests that this trial's intra-articular catheter treatments could be effective for post-operative pain management in total knee replacement?

Research shows that intra-articular catheters can reduce pain after knee replacement surgery by delivering relief directly to the surgical area. This method lowers pain levels and decreases the need for strong painkillers, like opioids, in the first 72 hours post-surgery. However, some studies found that when combined with other pain management methods, these catheters do not significantly enhance pain relief or reduce opioid use in the first 48 hours. In this trial, participants will receive either the BRAND 1 or BRAND 2 intra-articular catheter, both designed to offer similar benefits. While results are mixed, evidence supports their ability to lessen pain and aid in a more comfortable recovery after knee surgery. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Subjects who are indicated to use an intra-articular catheter pump system

Subjects willing and able to provide written informed consent to participate in this study

Exclusion Criteria

Subjects with history of chronic pain, neuropathic pain, or currently enrolled in pain management agreement

I am under 18 years old.

Subjects allergic to any components or treatment medications

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Post-operative

Participants undergo total knee arthroplasty and receive either standard care or an intra-articular catheter for pain management

Immediate post-operative period

1 visit (in-person)

Treatment

Participants receive pain management with or without intra-articular catheter and are monitored for pain scores

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and knee function

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intra-articular catheter

Trial Overview 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.

How Is the Trial Designed?

Group I: No post-operative intra-articular catheter Experimental Treatment 1 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 catheter Active Control 1 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 catheter Active Control 1 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.

Who Is Running the Clinical Trial?

OrthoCarolina Research Institute, Inc.

Lead Sponsor

Trials

37

Recruited

6,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06580899

Intra-Articular Catheter Total Knee Arthroplasty This is a prospective, randomized clinical trial evaluating three groups. The groups are: Group 1 (Control): Subjects that receive only the existing ...

2. withpower.com withpower.com/trial/intra-articular-catheter-for-total-knee-replacement-5713c

Intra-Articular Catheter for Total Knee Replacement Research shows that intra-articular catheters can effectively reduce pain after knee replacement surgery by delivering pain relief directly to the surgical area ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S235234412030234X

Intraarticular Pain Catheter Is Not a Necessary Modality for ... An intraarticular pain catheter in conjunction with a multimodal approach with intraoperative PAI after TKA does not improve 48-hour pain scores or opioid ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9891300/

Pain management after total knee arthroplasty Placement of intra-articular catheter (n = 10 RCTs) and subcutaneously (n = 1 RCT) was associated with reduced pain and opioid requirements up to 72 h ...

5. researchgate.net researchgate.net/publication/349457559_Adductor_Canal_Block_vs_Intra-articular_Catheter_in_Total_Knee_Arthroplasty_A_Double_Blinded_Randomized_Clinical_Trial

Adductor Canal Block vs Intra-articular Catheter in Total ... Adductor Canal Block vs Intra-articular Catheter in Total Knee Arthroplasty: A Double Blinded Randomized Clinical Trial. J Ortho Sci Res. 2021;2(1):1- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4947730/

Intra-articular bupivacaine after joint arthroplasty: a systematic ... The administration of IA bupivacaine after joint arthroplasty is effective for pain relief without increasing adverse effects.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1877056821000633

Implementation and results of an enhanced recovery (fast- ... Fast-track implementation ensured quality and safety of care; it did not increase the rate of complications in primary TKR. Mean length of stay was drastically ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8681887/

Intra-Articular Corticosteroid Injection After Total Knee ... The risk of infection following IASI is extremely low in the native knee and can be around 1 in 14,000 to 15,000 (0.007%) [22]. There have been ...