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NCT Number: NCT06251869

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

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

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Key information

Conditions

Compassion Body Temperature Changes Heat Stress Disorders Hyperthermia Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Ortopedie-Traumatologie, Secția 2

Cluj-Napoca, Cluj, 400347, Romania

Location status: Recruiting

Location contact

BENEA R HOREA, MD

CONTACT

[email protected]

0724528188 ext. +40

BENEA R HOREA, MD

PRINCIPAL_INVESTIGATOR

CICIO DENNIS, student

SUB_INVESTIGATOR

CIORNEI VLADIMIR, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total hip arthroplasty with electrocoagulation

Procedure

using normal technique

total hip arthroplasty without electrocoagulation

Procedure

using only scalpel and pean as hemostasis and incision

total knee arthroplasty with electrocoagulation

Procedure

using normal technique

total knee arthroplasty without electrocoagulation

Procedure

using only scalpel and pean as hemostasis and incision

Primary outcomes

  1. 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

  2. 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 .

  3. 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 .

  4. 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 .

  5. 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 .

  6. 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 .

Secondary outcomes

  1. 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 .

  2. 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 .

  3. 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 .

  4. mobilisation intervals of the patient

    Time frame: 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. .

  5. 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. .

  6. 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. .

  7. 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. .

  8. 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. .

  9. 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. .

  10. 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. .

  11. 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. .

  12. 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 .

Study contacts

Contact information is provided by the study sponsor or research team.

Cicio Dennis

CONTACT

[email protected]

0752457783 ext. +4

Ciornei Vladimir, MD

CONTACT

0748083163 ext. +4

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Acronym: evs

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2024
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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