Does Surgery-Induced Trauma Influence Postoperative Safety and Outcome Comparing Total vs. Medial Unicompartmental Knee Arthroplasty (SITA): A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- C-reactive protein (CRP)
研究概览
简要总结
Osteoarthritis (OA) is the most common type of arthritis, characterized by pain and physical disability. More than 10% of persons > 55 years have symptomatic OA, primarily involving the knees. Knee arthroplasty is considered a successful orthopaedic procedure in progressed knee OA (KOA) with severe pain and disability where non-surgical treatments have been tried.
It has long been recognized that injury to the body, either from trauma or surgery causes an inflammatory response. As TKA is considered a more invasive procedure compared with UKA, TKA and UKA may not trigger inflammatory reactions of the same magnitude. Differences in inflammatory response between TKA and UKA could help explain why differences in outcome are present, despite both procedures being technically successful.
Even though knee arthroplasty is a very common and successful procedure, there are no existing studies comparing the invasiveness of TKA and UKA. As morbidity and mortality rates differ between the groups, the aim of this prospective cohort study is to investigate whether the post-operative inflammatory responses differ between TKA and UKA, and secondarily whether this difference can explain the difference in outcome between the two procedures.
The investigators hypothesize that TKA generates a larger postoperative systemic inflammatory response compared with UKA due to more extensive periarticular soft tissue and bone trauma.
The study's primary outcome is C-reactive Protein (CRP) measured in blood 24 hours after surgery (22-26 hours after surgery ~ day 1).
Participants which are candidates for either a TKA or a UKA will through serial blood test measurement have their postoperative systemic inflammatory response measured. This further will be correlated to the clinical and functional outcomes over a 2-years postoperative follow-up period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or more
- •A clinical and radiological diagnosis of knee OA
- •Candidate for spinal anaesthesia
- •signed informed consent
排除标准
- •Planned surgery within the observation period other than KA
- •Any contraindications to the use of torniquet during surgery
- •Any contraindication to the administration of pre-operative dexamethasone
- •KA indication due to sequelae of e.g. fracture(s)
- •Previous infection of the target knee joint
- •Injection of medication or substances in the target knee within 3 months prior to participation
- •Immuno-inflammatory arthritis as cause of knee OA
- •Known autoimmune and/or inflammatory disease e.g. colitis ulcerosa
- •Active cancer diagnosis with ongoing treatment
- •Current systemic treatment with glucocorticoids equivalent to > 7.5 mg prednisolone/day
- •Surgery requiring spinal/general anaesthesia within the last 3 months prior to inclusion
- •Infection requiring medical/surgical treatment within the last 4 weeks prior to surgery for KA
- •Neurological dysfunction compromising mobility
- •Inability to understand or read Danish incl. instructions and questionnaires
- •Any other condition or impairment that, in the opinion of the investigator (or his/her delegate), makes a potential participant unsuitable for participation or which obstruct participation.
结局指标
主要结局
C-reactive protein (CRP)
时间窗: Day 1 (24 hours after surgery)
Marker of systemic inflammation and soft tissue injury
次要结局
- Interleukin-8 (IL8)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Metalloproteinases (MMP3, MMP9, MMP13)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Calprotectin - S100 calcium binding protein A8/A9 (S100A8/S100A9)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- S100 calcium-binding protein B (S100B)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Haemoglobin (Hb)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Platelets(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Knee pain (VAS)(Day 1, day 7, day 21, 3 months, 6 months, 12 months, 24 months (after surgery))
- Perioperative complications(1 day During admission (after surgery))
- The Forgotten Joint Score(Baseline, 3 months, 6 months, 12 months, 24 months (after surgery))
- White cell count (L+D)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Myoglobin(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Analgesia requirements after surgery(Day 1, day 7, day 21, 3 months (after surgery))
- 90 days complications (medical, surgical)(90 days (after surgery))
- Interleukin-6 (IL6)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- C-Reactive Protein (CRP)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Creatine Kinase (CK)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Length of stay/ Re-admissions within the first 90 days(90 days (after surgery))
- Pain Catastrophizing Scale (PCS)(Baseline)
- Tumor necrosis factor alfa (TNF-alfa)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Erythrocyte Sedimentation Rate (ESR)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Duration of surgery in minutes(Within the first week after surgery)
- Pain Detect Questionnaire (PDQ)(Baseline)
- Oxford Knee Score (OKS)(Baseline, 3 months, 6 months, 12 months, 24 months (after surgery))
- Patient acceptable Symptom States (PASS)(3 months, 6 months, 12 months, 24 months (after surgery))
- Interleukin-1-beta (IL1-beta)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Lactate dehydrogenase (LDH)(Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery))
- Postoperative x-rays(On day of surgery, or postoperative day 1, or postoperative day 2)
- Treatment failure (TF)(3 months, 6 months, 12 months, 24 months (after surgery))
- Data on any revisions performed on includes patient within 24 months(24 months (after surgery))
- European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)(Baseline, 3 months, 6 months, 12 months, 24 months (after surgery))
研究者
Anders Troelsen
Head of Clinical Orthopaedic Surgery Hvidovre (CORH), Clinical Professor
Hvidovre University Hospital