Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty (Electrocoagulation vs Scalpel)
NCT ID: NCT06251869
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2024-03-15
2027-02-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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hip electrocoagulation
group subjected to the use of electrocoagulation
total hip arthroplasty with electrocoagulation
using normal technique
hip scalpel
group subjected to the use of traditional hemostatic technique
total hip arthroplasty without electrocoagulation
using only scalpel and pean as hemostasis and incision
knee electrocoagulation
group subjected to the use of electrocoagulation
total knee arthroplasty with electrocoagulation
using normal technique
knee scalpel
group subjected to the use of traditional hemostatic technique
total knee arthroplasty without electrocoagulation
using only scalpel and pean as hemostasis and incision
Interventions
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total hip arthroplasty with electrocoagulation
using normal technique
total hip arthroplasty without electrocoagulation
using only scalpel and pean as hemostasis and incision
total knee arthroplasty with electrocoagulation
using normal technique
total knee arthroplasty without electrocoagulation
using only scalpel and pean as hemostasis and incision
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
90 Years
ALL
No
Sponsors
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Iuliu Hatieganu University of Medicine and Pharmacy
OTHER
Responsible Party
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Benea Horea
Assoc. Professor, Orthopedics and Traumatology Surgeon, MD, PhD
Principal Investigators
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Benea R Horea, MD
Role: PRINCIPAL_INVESTIGATOR
Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
Locations
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Clinica Ortopedie-Traumatologie, Secția 2
Cluj-Napoca, Cluj, Romania
Countries
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Central Contacts
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Ciornei Vladimir, MD
Role: CONTACT
Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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umfcj002
Identifier Type: -
Identifier Source: org_study_id
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