Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580899
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-08
Brief Title:
Intra-Articular Catheter Total Knee Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Continuous Local Infiltration Analgesia Intra-Articular Catheters for Pain Relief in Total Knee Replacement
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 TreatmentIntervention 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 TreatmentIntervention 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
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 TreatmentIntervention 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 TreatmentIntervention 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None