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

Recruiting

• Conditions: Compassion

• Registration Number: NCT06251869
• Lead Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy

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.

Study Timeline

• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Study Start: 2024-03-15
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2027-02-15
• Study Completion: 2027-02-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score	the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-168
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) subjective score	the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-96 .
International Knee Documentation Committee (IKDC) objective form	the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, score has different classifications on a scale from A to D, the latter being the worse outcome .
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) hip subjective score	the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-24 .
Harris Hip Score	the test will be administered pre operation, 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, score is on a scale, higher values mean a better outcome, scale 0-100 .
Forgotten Joint Score	the test will be administered 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-48 .

Secondary Outcome Measures

Name	Time	Method
leucocyte levels	the leucocyte levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months	for infection objectification .
thrombocyte levels	the thrombocyte levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months	for blood loss objectification .
joint flexion angle	the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
mobilisation intervals of the patient	through hospital stay of patient approximatively 4-7 days	the investigators will asses the time for the self-mobilisation of the patient to sit at the bed's edge, and then mobilisation with a walking aid like a walking frame. .
joint hyperextension angle	the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
hemaglobin levels	the hemaglobin levels will be registered pre-operation, then post-op day: 1, 2, 3, 4, and 5. Then at 2 weeks post-operation, 6 weeks, and 3 months	for blood loss objectification .
genu flexum angle	the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
joint internal rotation angle	the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
joint external rotation angle	the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
joint abduction angle	the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .
Number of participants with complications	through study completion, an average of 1 year	to objectify the superiority of one technique over the other, higher number signifies a worse outcome .
joint adduction angle	the measurements will be registered pre-operative, then 2 weeks post-operation, 6 weeks post-op, 3 months post-op, 6 months post-op, 1 year post-op	to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .

Trial Locations

Locations (1)

Clinica Ortopedie-Traumatologie, Secția 2; 🇷🇴 Cluj-Napoca, Cluj, Romania