Electrocoagulation vs. Cold Knife Cutting in Joint Arthroplasty: A Comparative Analysis in Knee and Hip Replacement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score
研究概览
简要总结
Comparison of clinical outcomes of electrocoagulation and non-electrocoagulation techniques in total hip and knee arthroplasty surgery
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS) knee subjective score
时间窗: 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
时间窗: 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
时间窗: 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 .
Hip dysfunction and Osteoarthritis Outcome Score for Joint Replacement (HOOS-JR) hip subjective score
时间窗: 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 .
Harris Hip Score
时间窗: 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 .
Forgotten Joint Score
时间窗: 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 .
次要结局
- 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)
- 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)
- 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)
- mobilisation intervals of the patient(through hospital stay of patient approximatively 4-7 days)
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- Number of participants with complications(through study completion, an average of 1 year)
- 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)
研究者
Benea Horea
Assoc. Professor, Orthopedics and Traumatology Surgeon, MD, PhD
Iuliu Hatieganu University of Medicine and Pharmacy