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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура total hip arthroplasty with electrocoagulation
  using normal technique
• Процедура total hip arthroplasty without electrocoagulation
  using only scalpel and pean as hemostasis and incision
• Процедура total knee arthroplasty with electrocoagulation
  using normal technique
• Процедура total knee arthroplasty without electrocoagulation
  using only scalpel and pean as hemostasis and incision

Первичные конечные точки

• Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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]

Вторичные конечные точки (12)

• hemaglobin levels [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: through hospital stay of patient approximatively 4-7 days]
• joint hyperextension angle [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Румыния · 1 центр

• Clinica Ortopedie-Traumatologie, Secția 2 — Cluj-Napoca

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06251869 · umfcj002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗