Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251869
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2023-12-14
Brief Title:
Electrocoagulation vs Cold Knife Cutting in Joint Arthroplasty Electrocoagulation vs Scalpel
Sponsor:
Iuliu Hatieganu University of Medicine and Pharmacy
Organization:
Iuliu Hatieganu University of Medicine and Pharmacy
Study Overview
Official Title:
Electrocoagulation vs Cold Knife Cutting in Joint Arthroplasty A Comparative Analysis in Knee and Hip Replacement
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
evs
Brief Summary:
Comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery
Detailed Description:
Objectives
A To evaluate the effectiveness of electrocoagulation
To measure the reduction in intraoperative bleeding volume when using electrocoagulation
Analyse the impact of electrocoagulation on surgical visibility and accuracy during implant placement
B Comparison of surgical outcomes
Investigate the incidence of intra- and postoperative complications such as incidental vascular-nerve injury wound infections deep vein thrombosis and implant-related problems in patients operated on with electrocoagulation versus techniques without electrocoagulation
Examine the influence of haemostatic technique on the need for blood transfusion during or after surgery
Evaluation of long-term functional outcomes and patient satisfaction including joint stability and range of motion in both groups
C Review of patient recovery and period of hospitalization
Analysis of the impact of electrocoagulation on length of hospitalisation and time to ambulation
Assessment of postoperative pain levels and analgesic medication use between the two groups
Patients return to daily activities and overall quality of life after surgery
D Comparison of data obtained with other studies conducted internationally
A To evaluate the effectiveness of electrocoagulation
To measure the reduction in intraoperative bleeding volume when using electrocoagulation
Analyse the impact of electrocoagulation on surgical visibility and accuracy during implant placement
B Comparison of surgical outcomes
Investigate the incidence of intra- and postoperative complications such as incidental vascular-nerve injury wound infections deep vein thrombosis and implant-related problems in patients operated on with electrocoagulation versus techniques without electrocoagulation
Examine the influence of haemostatic technique on the need for blood transfusion during or after surgery
Evaluation of long-term functional outcomes and patient satisfaction including joint stability and range of motion in both groups
C Review of patient recovery and period of hospitalization
Analysis of the impact of electrocoagulation on length of hospitalisation and time to ambulation
Assessment of postoperative pain levels and analgesic medication use between the two groups
Patients return to daily activities and overall quality of life after surgery
D Comparison of data obtained with other studies conducted internationally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None