Compassion
Conditions
Keywords
electrocoagulation, cold knife, scalpel, joint arthroplasty, knee replacement, hip replacement, comparative analysis, surgical techniques, orthopedics, outcome assessment
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.
Interventions
PROCEDUREtotal hip arthroplasty with electrocoagulation
using normal technique
PROCEDUREtotal hip arthroplasty without electrocoagulation
using only scalpel and pean as hemostasis and incision
PROCEDUREtotal knee arthroplasty with electrocoagulation
using normal technique
PROCEDUREtotal knee arthroplasty without electrocoagulation
using only scalpel and pean as hemostasis and incision
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score | 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 | to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-168 |
| Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) subjective score | 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 | to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-96 . |
| International Knee Documentation Committee (IKDC) objective form | 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 | to objectify the recovery, score has different classifications on a scale from A to D, the latter being the worse outcome . |
| Harris Hip Score | 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 | to objectify the recovery, score is on a scale, higher values mean a better outcome, scale 0-100 . |
| Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) hip subjective score | 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 | to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-24 . |
| Forgotten Joint Score | 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 | to objectify the recovery, score is on a scale, higher values mean a worse outcome, scale 0-48 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| genu flexum angle | 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 | to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. . |
| joint external rotation angle | 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 | to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. . |
| joint internal rotation angle | 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 | to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. . |
| hemaglobin levels | 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 | for blood loss objectification . |
| joint adduction angle | 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 | to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. . |
| Number of participants with complications | through study completion, an average of 1 year | to objectify the superiority of one technique over the other, higher number signifies a worse outcome . |
| joint abduction angle | 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 | to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. . |
| leucocyte levels | 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 | for infection objectification . |
| thrombocyte levels | 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 | for blood loss objectification . |
| mobilisation intervals of the patient | through hospital stay of patient approximatively 4-7 days | 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. . |
| joint hyperextension angle | 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 | to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. . |
| joint flexion angle | 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 | to objectify the recovery, the measurement will be done with a measuring angle during objective evaluation. . |
Countries
Romania
Contacts
Primary ContactCicio Dennis
Backup ContactCiornei Vladimir, MD
Outcome results
None listed