Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-29 @ 2:04 AM
Study NCT ID:
NCT06251869
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2023-12-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty (Electrocoagulation vs Scalpel)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019644', 'term': 'Arthroplasty, Replacement, Hip'}, {'id': 'D004564', 'term': 'Electrocoagulation'}, {'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2027-02-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-28', 'studyFirstSubmitDate': '2023-12-14', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score', 'timeFrame': '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', 'description': 'to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-168'}, {'measure': 'Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) subjective score', 'timeFrame': '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', 'description': 'to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-96 .'}, {'measure': 'International Knee Documentation Committee (IKDC) objective form', 'timeFrame': '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', 'description': 'to objectify the recovery, score has different classifications on a scale from A to D, the latter being the worse outcome .'}, {'measure': 'Harris Hip Score', 'timeFrame': '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', 'description': 'to objectify the recovery, score is on a scale, higher values mean a better outcome, scale 0-100 .'}, {'measure': 'Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) hip subjective score', 'timeFrame': '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', 'description': 'to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-24 .'}, {'measure': 'Forgotten Joint Score', 'timeFrame': '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', 'description': 'to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-48 .'}], 'secondaryOutcomes': [{'measure': 'hemaglobin levels', 'timeFrame': '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', 'description': 'for blood loss objectification .'}, {'measure': 'leucocyte levels', 'timeFrame': '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', 'description': 'for infection objectification .'}, {'measure': 'thrombocyte levels', 'timeFrame': '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', 'description': 'for blood loss objectification .'}, {'measure': 'mobilisation intervals of the patient', 'timeFrame': 'through hospital stay of patient approximatively 4-7 days', 'description': "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. ."}, {'measure': 'joint hyperextension angle', 'timeFrame': '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', 'description': 'to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .'}, {'measure': 'joint flexion angle', 'timeFrame': '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', 'description': 'to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .'}, {'measure': 'genu flexum angle', 'timeFrame': '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', 'description': 'to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .'}, {'measure': 'joint external rotation angle', 'timeFrame': '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', 'description': 'to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .'}, {'measure': 'joint internal rotation angle', 'timeFrame': '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', 'description': 'to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .'}, {'measure': 'joint abduction angle', 'timeFrame': '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', 'description': 'to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .'}, {'measure': 'joint adduction angle', 'timeFrame': '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', 'description': 'to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. .'}, {'measure': 'Number of participants with complications', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'to objectify the superiority of one technique over the other, higher number signifies a worse outcome .'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['electrocoagulation', 'cold knife', 'scalpel', 'joint arthroplasty', 'knee replacement', 'hip replacement', 'comparative analysis', 'surgical techniques', 'orthopedics', 'outcome assessment'], 'conditions': ['Compassion']}, 'referencesModule': {'references': [{'pmid': '31094978', 'type': 'BACKGROUND', '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.'}, {'pmid': '31940962', 'type': 'BACKGROUND', '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.'}, {'pmid': '32600294', 'type': 'BACKGROUND', '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.'}, {'pmid': '22000572', 'type': 'BACKGROUND', 'citation': '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': '25523661', 'type': 'BACKGROUND', '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.'}, {'pmid': '29968137', 'type': 'BACKGROUND', '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.'}, {'pmid': '27007131', 'type': 'BACKGROUND', '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.'}, {'pmid': '8209936', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'Comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery', 'detailedDescription': "Objectives:\n\nA. To evaluate the effectiveness of electrocoagulation:\n\n* To measure the reduction in intraoperative bleeding volume when using electrocoagulation.\n* Analyse the impact of electrocoagulation on surgical visibility and accuracy during implant placement.\n\nB. Comparison of surgical outcomes:\n\n* 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.\n* Examine the influence of haemostatic technique on the need for blood transfusion during or after surgery.\n* Evaluation of long-term functional outcomes and patient satisfaction, including joint stability and range of motion, in both groups.\n\nC. Review of patient recovery and period of hospitalization:\n\n* Analysis of the impact of electrocoagulation on length of hospitalisation, and time to ambulation.\n* Assessment of postoperative pain levels and analgesic medication use between the two groups.\n* Patients' return to daily activities and overall quality of life after surgery.\n\nD. Comparison of data obtained with other studies conducted internationally."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'anyone who needs a hip/knee replacemnt', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have given informed consent to the procedure\n* Patients admitted over 18 years of age\n* Patients with pathology requiring primary joint replacement (symptomatic gonarthrosis/coxarthrosis, Avascular necrosis (AVN) of the femoral head , femoral neck fractures, etc)\n\nExclusion Criteria:\n\n* Contraindications for major surgery or anaesthesia\n* Patients with active infections that could interfere with outcome assessment\n* Patients unable to give informed consent for psychological or cognitive reasons\n* Severe medical conditions such as coagulopathies that may significantly influence outcomes\n* Patients unable or unwilling to adhere to the required follow-up period\n* Patients who died during the study period\n* Patients with revision prosthesis operations'}, 'identificationModule': {'nctId': 'NCT06251869', 'acronym': 'evs', 'briefTitle': 'Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty (Electrocoagulation vs Scalpel)', 'organization': {'class': 'OTHER', 'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy'}, 'officialTitle': 'Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty: A Comparative Analysis in Knee and Hip Replacement', 'orgStudyIdInfo': {'id': 'umfcj002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'hip electrocoagulation', 'description': 'group subjected to the use of electrocoagulation', 'interventionNames': ['Procedure: total hip arthroplasty with electrocoagulation']}, {'label': 'hip scalpel', 'description': 'group subjected to the use of traditional hemostatic technique', 'interventionNames': ['Procedure: total hip arthroplasty without electrocoagulation']}, {'label': 'knee electrocoagulation', 'description': 'group subjected to the use of electrocoagulation', 'interventionNames': ['Procedure: total knee arthroplasty with electrocoagulation']}, {'label': 'knee scalpel', 'description': 'group subjected to the use of traditional hemostatic technique', 'interventionNames': ['Procedure: total knee arthroplasty without electrocoagulation']}], 'interventions': [{'name': 'total hip arthroplasty with electrocoagulation', 'type': 'PROCEDURE', 'description': 'using normal technique', 'armGroupLabels': ['hip electrocoagulation']}, {'name': 'total hip arthroplasty without electrocoagulation', 'type': 'PROCEDURE', 'description': 'using only scalpel and pean as hemostasis and incision', 'armGroupLabels': ['hip scalpel']}, {'name': 'total knee arthroplasty with electrocoagulation', 'type': 'PROCEDURE', 'description': 'using normal technique', 'armGroupLabels': ['knee electrocoagulation']}, {'name': 'total knee arthroplasty without electrocoagulation', 'type': 'PROCEDURE', 'description': 'using only scalpel and pean as hemostasis and incision', 'armGroupLabels': ['knee scalpel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400347', 'city': 'Cluj-Napoca', 'state': 'Cluj', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'BENEA R HOREA, MD', 'role': 'CONTACT', 'email': 'beneahorea@yahoo.com', 'phone': '0724528188', 'phoneExt': '+40'}, {'name': 'BENEA R HOREA, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'CICIO DENNIS, student', 'role': 'SUB_INVESTIGATOR'}, {'name': 'CIORNEI VLADIMIR, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Clinica Ortopedie-Traumatologie, Secția 2', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}], 'centralContacts': [{'name': 'Cicio Dennis', 'role': 'CONTACT', 'email': 'ciciodennis@gmail.com', 'phone': '0752457783', 'phoneExt': '+4'}, {'name': 'Ciornei Vladimir, MD', 'role': 'CONTACT', 'phone': '0748083163', 'phoneExt': '+4'}], 'overallOfficials': [{'name': 'Benea R Horea, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Professor, Orthopedics and Traumatology Surgeon, MD, PhD', 'investigatorFullName': 'Benea Horea', 'investigatorAffiliation': 'Iuliu Hatieganu University of Medicine and Pharmacy'}}}}