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

February 1, 2024 updated by: Benea Horea, Iuliu Hatieganu University of Medicine and Pharmacy

Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty: A Comparative Analysis in Knee and Hip Replacement

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

Study Overview

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 Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ciornei Vladimir, MD
  • Phone Number: +4 0748083163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

anyone who needs a hip/knee replacemnt

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
hip electrocoagulation
group subjected to the use of electrocoagulation
using normal technique
hip scalpel
group subjected to the use of traditional hemostatic technique
using only scalpel and pean as hemostasis and incision
knee electrocoagulation
group subjected to the use of electrocoagulation
using normal technique
knee scalpel
group subjected to the use of traditional hemostatic technique
using only scalpel and pean as hemostasis and incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score
Time Frame: 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
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
Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) subjective score
Time Frame: 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 .
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
International Knee Documentation Committee (IKDC) objective form
Time Frame: 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 .
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
Harris Hip Score
Time Frame: 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 .
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
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) hip subjective score
Time Frame: 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 .
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
Forgotten Joint Score
Time Frame: 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 .
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemaglobin levels
Time Frame: 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 .
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
leucocyte levels
Time Frame: 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 .
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
thrombocyte levels
Time Frame: 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 .
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
mobilisation intervals of the patient
Time Frame: through hospital stay of patient approximatively 4-7 days
we 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. .
through hospital stay of patient approximatively 4-7 days
blood loss
Time Frame: Intraoperative
blood lost during the operation .
Intraoperative
joint hyperextension angle
Time Frame: 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. .
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
joint flexion angle
Time Frame: 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. .
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
genu flexum angle
Time Frame: 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. .
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
joint external rotation angle
Time Frame: 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. .
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
joint internal rotation angle
Time Frame: 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. .
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
joint abduction angle
Time Frame: 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. .
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
joint adduction angle
Time Frame: 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. .
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
Number of participants with complications
Time Frame: through study completion, an average of 1 year
to objectify the superiority of one technique over the other, higher number signifies a worse outcome .
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Benea R Horea, MD, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

December 14, 2023

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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