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

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

• Status: Recruiting
• Conditions: Compassion
• Intervention / Treatment: Procedure: total hip arthroplasty with electrocoagulation; Procedure: total hip arthroplasty without electrocoagulation; Procedure: total knee arthroplasty with electrocoagulation; Procedure: total knee arthroplasty without electrocoagulation

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

• Study Contact: Name: Cicio Dennis; Phone Number: +4 0752457783; Email: ciciodennis@gmail.com
• Study Contact Backup: Name: Ciornei Vladimir, MD; Phone Number: +4 0748083163

Study Locations

• Romania
  • Cluj
    • Cluj-Napoca, Cluj, Romania, 400347
      • Recruiting
      • Clinica Ortopedie-Traumatologie, Secția 2
      • Contact: BENEA R HOREA, MD; Phone Number: +40 0724528188; Email: beneahorea@yahoo.com
      • Principal Investigator: BENEA R HOREA, MD
      • Sub-Investigator: CICIO DENNIS, student
      • Sub-Investigator: CIORNEI VLADIMIR, MD

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
hip electrocoagulation; group subjected to the use of electrocoagulation	Procedure: total hip arthroplasty with electrocoagulation; using normal technique
hip scalpel; group subjected to the use of traditional hemostatic technique	Procedure: total hip arthroplasty without electrocoagulation; using only scalpel and pean as hemostasis and incision
knee electrocoagulation; group subjected to the use of electrocoagulation	Procedure: total knee arthroplasty with electrocoagulation; using normal technique
knee scalpel; group subjected to the use of traditional hemostatic technique	Procedure: total knee arthroplasty without electrocoagulation; 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	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	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	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	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	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	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	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	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	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
joint hyperextension angle	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	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	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	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	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	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	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	to objectify the superiority of one technique over the other, higher number signifies a worse outcome .	through study completion, an average of 1 year
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. .	through hospital stay of patient approximatively 4-7 days

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Behrend H, Giesinger K, Giesinger JM, Kuster MS. The "forgotten joint" as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty. 2012 Mar;27(3):430-436.e1. doi: 10.1016/j.arth.2011.06.035. Epub 2011 Oct 13.
• Sonntag R, Gibmeier J, Pulvermacher S, Mueller U, Eckert J, Braun S, Reichkendler M, Kretzer JP. Electrocautery Damage Can Reduce Implant Fatigue Strength: Cases and in Vitro Investigation. J Bone Joint Surg Am. 2019 May 15;101(10):868-878. doi: 10.2106/JBJS.18.00259.
• Lacitignola L, Desantis S, Izzo G, Staffieri F, Rossi R, Resta L, Crovace A. Comparative Morphological Effects of Cold-Blade, Electrosurgical, and Plasma Scalpels on Dog Skin. Vet Sci. 2020 Jan 12;7(1):8. doi: 10.3390/vetsci7010008.
• Lin W, Dai Y, Niu J, Yang G, Li M, Wang F. Scalpel can achieve better clinical outcomes compared with electric cautery in primary total knee arthroplasty: a comparison study. BMC Musculoskelet Disord. 2020 Jun 29;21(1):409. doi: 10.1186/s12891-020-03457-1.
• Cadeddu JA. Re: Lateral temperature spread of monopolar, bipolar and ultrasonic instruments for robot-assisted laparoscopic surgery. J Urol. 2015 Jan;193(1):129. doi: 10.1016/j.juro.2014.10.014. Epub 2014 Oct 12. No abstract available.
• Tammachote N, Kanitnate S. Electric cautery does not reduce blood loss in primary total knee arthroplasty compared with scalpel only surgery a double-blinded randomized controlled trial. Int Orthop. 2018 Dec;42(12):2755-2760. doi: 10.1007/s00264-018-4048-y. Epub 2018 Jul 3.
• Ozturk K, Kaya I, Turhal G, Ozturk A, Gursan G, Akyildiz S. A comparison of electrothermal bipolar vessel sealing system and electrocautery in selective neck dissection. Eur Arch Otorhinolaryngol. 2016 Nov;273(11):3835-3838. doi: 10.1007/s00405-016-3999-0. Epub 2016 Mar 23.
• Groot G, Chappell EW. Electrocautery used to create incisions does not increase wound infection rates. Am J Surg. 1994 Jun;167(6):601-3. doi: 10.1016/0002-9610(94)90106-6.

Study record dates

Study Major Dates

• Study Start (Actual): March 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): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: hip replacement; knee replacement; cold knife; outcome assessment; joint arthroplasty; orthopedics; scalpel; electrocoagulation; surgical techniques; comparative analysis
• Other Study ID Numbers: umfcj002

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