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

ConditionCompassion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorIuliu Hatieganu University of Medicine and Pharmacy

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial population

anyone who needs a hip/knee replacemnt

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • total hip arthroplasty with electrocoagulation

    Procedure/Surgery

    using normal technique

  • total hip arthroplasty without electrocoagulation

    Procedure/Surgery

    using only scalpel and pean as hemostasis and incision

  • total knee arthroplasty with electrocoagulation

    Procedure/Surgery

    using normal technique

  • total knee arthroplasty without electrocoagulation

    Procedure/Surgery

    using only scalpel and pean as hemostasis and incision

Treatment groups

700 Participants
are divided into 4 treatment groups
Group A: hip electrocoagulation1 intervention
Group B: hip scalpel1 intervention
Group C: knee electrocoagulation1 intervention
Group D: knee scalpel1 intervention

Trial outcomes

Primary outcomes

1

Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score

to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-168

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
2

Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) subjective score

to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-96 .

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
3

International Knee Documentation Committee (IKDC) objective form

to objectify the recovery, score has different classifications on a scale from A to D, the latter being the worse outcome .

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
4

Harris Hip Score

to objectify the recovery, score is on a scale, higher values mean a better outcome, scale 0-100 .

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

Secondary outcomes

1

hemaglobin levels

for blood loss objectification .

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
2

leucocyte levels

for infection objectification .

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
3

thrombocyte levels

for blood loss objectification .

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
4

mobilisation intervals of the patient

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. .

Time frame
through hospital stay of patient approximatively 4-7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Iuliu Hatieganu University of Medicine and Pharmacy

Lead sponsor

Source ClinicalTrials.gov
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