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

Compassion Clinical Trial

— evs  

Official title:

Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty: A Comparative Analysis in Knee and Hip Replacement

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06251869
• Other study ID #: umfcj002
• Status: Recruiting
• Start date: March 15, 2024
• Est. completion date: February 15, 2027

Study information

• Verified date: April 2024
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: Cicio Dennis
• Phone: 0752457783
• Email: ciciodennis[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: February 15, 2027
• Est. primary completion date: February 15, 2027
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Compassion

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Romania	Clinica Ortopedie-Traumatologie, Sec?ia 2	Cluj-Napoca	Cluj

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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