Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty (Electrocoagulation vs Scalpel) (evs)

Iuliu Hatieganu University of Medicine and Pharmacy

Status: Enrolling

Conditions: Compassion

Treatments: Procedure: total knee arthroplasty with electrocoagulation; Procedure: total hip arthroplasty without electrocoagulation; Procedure: total knee arthroplasty without electrocoagulation; Procedure: total hip arthroplasty with electrocoagulation

Study type: Observational

Funder types: Other

Identifiers

NCT06251869

umfcj002

Details and patient eligibility

About

Comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery

Full 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.

Enrollment: 700 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have given informed consent to the procedure
• Patients admitted over 18 years of age
• Patients with pathology requiring primary joint replacement (symptomatic gonarthrosis/coxarthrosis, Avascular necrosis (AVN) of the femoral head , femoral neck fractures, etc)

Exclusion criteria

• Contraindications for major surgery or anaesthesia
• Patients with active infections that could interfere with outcome assessment
• Patients unable to give informed consent for psychological or cognitive reasons
• Severe medical conditions such as coagulopathies that may significantly influence outcomes
• Patients unable or unwilling to adhere to the required follow-up period
• Patients who died during the study period
• Patients with revision prosthesis operations

Trial design

700 participants in 4 patient groups

hip electrocoagulation

Description:

group subjected to the use of electrocoagulation

Treatment:

Procedure: total hip arthroplasty with electrocoagulation

hip scalpel

Description:

group subjected to the use of traditional hemostatic technique

Treatment:

Procedure: total hip arthroplasty without electrocoagulation

knee electrocoagulation

Description:

group subjected to the use of electrocoagulation

Treatment:

Procedure: total knee arthroplasty with electrocoagulation

knee scalpel

Description:

group subjected to the use of traditional hemostatic technique

Treatment:

Procedure: total knee arthroplasty without electrocoagulation