Clinical trial NCT06251869: Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty (Electrocoagulation vs Scalpel)
Official title: Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty: A Comparative Analysis in Knee and Hip Replacement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Compassion
Keywords: electrocoagulation
cold knife
scalpel
joint arthroplasty
knee replacement
hip replacement
comparative analysis
surgical techniques
orthopedics
outcome assessment
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: anyone who needs a hip/knee replacemnt

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
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
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
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
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
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
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
Secondary outcomes:
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
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
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
measure: mobilisation intervals of the patient
timeFrame: through hospital stay of patient approximatively 4-7 days
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
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
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
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
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
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
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
measure: Number of participants with complications
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Clinica Ortopedie-Traumatologie, Secția 2
state: Cluj
Study officials:
affiliation: Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania
name: Benea R Horea, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.