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

NCT06251869 | Recruiting

• 1 other identifier: umfcj002
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Compassion

Keywords

electrocoagulation; cold knife; scalpel; joint arthroplasty; knee replacement; hip replacement; comparative analysis; surgical techniques; orthopedics; outcome assessment

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• 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

• 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

• 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

• mobilisation intervals of the patient

  through hospital stay of patient approximatively 4-7 days

• 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

Study Arms (4)

hip electrocoagulation

group subjected to the use of electrocoagulation

Procedure: total hip arthroplasty with electrocoagulation

hip scalpel

group subjected to the use of traditional hemostatic technique

Procedure: total hip arthroplasty without electrocoagulation

knee electrocoagulation

group subjected to the use of electrocoagulation

Procedure: total knee arthroplasty with electrocoagulation

knee scalpel

group subjected to the use of traditional hemostatic technique

Procedure: total knee arthroplasty without electrocoagulation

Interventions

total hip arthroplasty with electrocoagulation PROCEDURE

using normal technique

hip electrocoagulation

total hip arthroplasty without electrocoagulation PROCEDURE

using only scalpel and pean as hemostasis and incision

hip scalpel

total knee arthroplasty with electrocoagulation PROCEDURE

using normal technique

knee electrocoagulation

total knee arthroplasty without electrocoagulation PROCEDURE

using only scalpel and pean as hemostasis and incision

knee scalpel

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

anyone who needs a hip/knee replacemnt

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Clinica Ortopedie-Traumatologie, Secția 2

Cluj-Napoca, Cluj, 400347, Romania

RECRUITING

Related Publications (8)

• 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.

  PMID: 31094978 BACKGROUND

• 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.

  PMID: 31940962 BACKGROUND

• 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.

  PMID: 32600294 BACKGROUND

• 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.

  PMID: 22000572 BACKGROUND

• 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.

  PMID: 25523661 BACKGROUND

• 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.

  PMID: 29968137 BACKGROUND

• 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.

  PMID: 27007131 BACKGROUND

• 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.

  PMID: 8209936 BACKGROUND

MeSH Terms

Conditions

Hyperthermia

Interventions

Arthroplasty, Replacement, Hip; Electrocoagulation; Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation; Cautery; Therapeutics; Ablation Techniques

Study Officials

• Benea R Horea, MD

  Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cicio Dennis

CONTACT

0752457783; ciciodennis@gmail.com

Ciornei Vladimir, MD

CONTACT

0748083163

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Professor, Orthopedics and Traumatology Surgeon, MD, PhD

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: February 9, 2024
• Study Start: March 15, 2024
• Primary Completion (Estimated): February 15, 2027
• Study Completion (Estimated): February 15, 2027
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

RO (1)