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

NCT ID: NCT06251869

Last Updated: 2025-05-01

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-15

Study Completion Date

2027-02-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Compassion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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hip electrocoagulation

group subjected to the use of electrocoagulation

total hip arthroplasty with electrocoagulation

Intervention Type PROCEDURE

using normal technique

hip scalpel

group subjected to the use of traditional hemostatic technique

total hip arthroplasty without electrocoagulation

Intervention Type PROCEDURE

using only scalpel and pean as hemostasis and incision

knee electrocoagulation

group subjected to the use of electrocoagulation

total knee arthroplasty with electrocoagulation

Intervention Type PROCEDURE

using normal technique

knee scalpel

group subjected to the use of traditional hemostatic technique

total knee arthroplasty without electrocoagulation

Intervention Type PROCEDURE

using only scalpel and pean as hemostasis and incision

Interventions

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total hip arthroplasty with electrocoagulation

using normal technique

Intervention Type PROCEDURE

total hip arthroplasty without electrocoagulation

using only scalpel and pean as hemostasis and incision

Intervention Type PROCEDURE

total knee arthroplasty with electrocoagulation

using normal technique

Intervention Type PROCEDURE

total knee arthroplasty without electrocoagulation

using only scalpel and pean as hemostasis and incision

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Benea Horea

Assoc. Professor, Orthopedics and Traumatology Surgeon, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Cicio Dennis

Role: CONTACT

0752457783 ext. +4

Ciornei Vladimir, MD

Role: CONTACT

0748083163 ext. +4

Facility Contacts

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BENEA R HOREA, MD

Role: primary

0724528188 ext. +40

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.

Reference Type BACKGROUND
PMID: 31094978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31940962 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32600294 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22000572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25523661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29968137 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27007131 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8209936 (View on PubMed)

Other Identifiers

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umfcj002

Identifier Type: -

Identifier Source: org_study_id

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