Continuous Local Infiltration AnalgesiaPhase 4NCT06580899
Intra-Articular Catheter Total Knee Arthroplasty
A Phase 4 study testing Intra-articular catheter in people with Continuous Local Infiltration Analgesia and Intra-articular Catheter, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Local Infiltration Analgesia, Intra-articular Catheter, Total Knee Arthroplasty
- What is being tested?
- Intra-articular catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
OrthoCarolina Research Institute, Inc.
Charlotte, North Carolina, 28207
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Continuous Local Infiltration Analgesia, Intra-articular Catheter, Total Knee Arthroplasty
- Being tested
- Intra-articular catheter, Routine Standard of Care Treatment
- Keywords
- continuous local infiltration analgesia, intra-articular catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular catheterDevice
Intra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-op period
Routine Standard of Care TreatmentOther
No changes to what would occur outside of the study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Intra-articular catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
Numeric Pain Rating Scale (0-10 scale where 10 is worse)
Measured: 2 days postoperative, 2 weeks postoperative
Secondary outcomes (1)
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
Measured: 6 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start14 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Continuous Local Infiltration AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580899
- Sponsor's protocol ID
- CONC005
- Status last verified
- Mar 2026
- First submitted
- 8 Aug 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD sharing
Publications
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.
PubMed 28844632Li 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.
PubMed 31663286Horlocker TT. Pain management in total joint arthroplasty: a historical review. Orthopedics. 2010 Sep;33(9 Suppl):14-9. doi: 10.3928/01477447-20100722-65.
PubMed 20839717Soffin 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.
PubMed 29808972Pugely 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.
PubMed 23269359
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Continuous Local Infiltration Analgesia Intra-Articular Catheters for Pain Relief in Total Knee Replacement
- ClinicalTrials.gov ID
- NCT06580899
- Acronym / sponsor ID
- CONC005
- Conditions
- Continuous Local Infiltration Analgesia, Intra-articular Catheter, Total Knee Arthroplasty
- Keywords
- continuous local infiltration analgesia, intra-articular catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Study start
- 14 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No post-operative intra-articular catheter | Other | Other: Routine Standard of Care TreatmentSubjects that receive ONLY the existing standard of care (SOC) multimodal pain management protocol and DO NOT receive post-operative intra-articular catheter. |
| BRAND 1 intra-articular catheter | Active comparator | Device: Intra-articular catheterSubjects that receive the BRAND 1 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period. |
| BRAND 2 intra-articular catheter | Active comparator | Device: Intra-articular catheterSubjects that receive the newer BRAND 2 intra-articular catheter pump with existing SOC multimodal pain management protocol in the immediate post-op period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-articular catheterIntra-articular catheter pump with existing standard-of-care multimodal pain management protocol in the immediate post-op period | Device | BRAND 1 intra-articular catheter, BRAND 2 intra-articular catheter |
| Routine Standard of Care TreatmentNo changes to what would occur outside of the study. | Other | No post-operative intra-articular catheter |
Primary outcome
Numeric Pain Rating Scale
Time frame: 2 days postoperative, 2 weeks postoperative
Numeric Pain Rating Scale (0-10 scale where 10 is worse)
1 secondary outcome
Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr.)
Time frame: 6 weeks postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Background: PubMed 28844632Gunaratne 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.
- Background: PubMed 31663286Li 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.
- Background: PubMed 20839717Horlocker TT. Pain management in total joint arthroplasty: a historical review. Orthopedics. 2010 Sep;33(9 Suppl):14-9. doi: 10.3928/01477447-20100722-65.
- Background: PubMed 29808972Soffin 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.
- Background: PubMed 23269359Pugely 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.
- Individual participant dataSharing planned: No. No IPD sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intra-articular catheter in people with Continuous Local Infiltration Analgesia and Intra-articular Catheter, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (time frame: 2 days postoperative, 2 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06580899, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.