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全膝关节置换术与单间室膝关节置换术 (SITA) 后手术诱发的创伤 (SITA)

2026年9月17日 更新者:Anders Troelsen、Hvidovre University Hospital

手术引起的创伤是否会影响术后安全性和结果比较全膝关节置换术与内侧单间室膝关节置换术 (SITA):一项前瞻性队列研究

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.

研究概览

研究类型

观察性的

注册 (实际的)

29

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Hvidovre、丹麦、2650
        • Department of Orthopaedic Surgery, Amager Hvidovre Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Study participants will be adults (i.e. at least 18 years old) who have diagnosis of KOA with an indication for primary KA (medial unicondylar or total arthroplasty).

描述

Inclusion Criteria:

  • Age 18 or more
  • A clinical and radiological diagnosis of knee OA
  • Candidate for spinal anaesthesia
  • signed informed consent

Exclusion Criteria:

  • 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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:COHORT
  • 时间观点:PROSPECTIVE

队列和干预

团体/队列
干预/治疗
Total Knee Arhroplasty (TKA)

Study participants will be adults (i.e. at least 18 years old) who have diagnosis of KOA with an indication for primary Total Knee Arthroplasty (TKA).

The choice between TKA and UKA is based on the radiological presentation of the knee KOA on an x-ray. A surgery with TKA involves the replacement of both the medial and lateral compartments of the knee.

Unicompartmental Knee Arthroplasty (UKA)

Study participants will be adults (i.e. at least 18 years old) who have diagnosis of KOA with an indication for primary medial Unicompartmental Knee Arthroplasty (UKA).

The choice between TKA and UKA is based on the radiological presentation of the knee KOA on an x-ray. A surgery with UKA involves the replacement of one compartment.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
C-reactive protein (CRP)
大体时间:Day 1 (24 hours after surgery)

Marker of systemic inflammation and soft tissue injury

Day 1 (24 hours after surgery)

次要结果测量

结果测量
措施说明
大体时间
Interleukin-1-beta (IL1-beta)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Interleukin-6 (IL6)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Interleukin-8 (IL8)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Tumor necrosis factor alfa (TNF-alfa)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Metalloproteinases (MMP3, MMP9, MMP13)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Calprotectin - S100 calcium binding protein A8/A9 (S100A8/S100A9)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
S100 calcium-binding protein B (S100B)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
C-Reactive Protein (CRP)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Haemoglobin (Hb)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Erythrocyte Sedimentation Rate (ESR)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
White cell count (L+D)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Platelets
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Myoglobin
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Lactate dehydrogenase (LDH)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Creatine Kinase (CK)
大体时间:Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

Marker of systemic inflammation and soft tissue injury

Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Duration of surgery in minutes
大体时间:Within the first week after surgery

The time from when the surgeon of record starts the procedure until he/she leaves the procedure.

This information will be collected from the patient's medical record.

Within the first week after surgery
Postoperative x-rays
大体时间:On day of surgery, or postoperative day 1, or postoperative day 2

Postoperative x-rays of the knee are performed routinely in order to evaluate whether implants are placed in accordance with recommendations.

On day of surgery, or postoperative day 1, or postoperative day 2
Knee pain (VAS)
大体时间:Day 1, day 7, day 21, 3 months, 6 months, 12 months, 24 months (after surgery)

Pain assessed using the visual analogue score (VAS) following surgery. The Scores go from 0-10. 0 = no pain. 10 = the most pain. The patients indicate how their pain during the last 24 hours fit in to the scale.

Day 1, day 7, day 21, 3 months, 6 months, 12 months, 24 months (after surgery)
Analgesia requirements after surgery
大体时间:Day 1, day 7, day 21, 3 months (after surgery)

Both preoperative and postoperative requirement of analgesia will be noted. Analgesia requirement will include Paracetamol, NSAID, Acetylic Acids and Opioids. Type of anaesthesia/sedation used during surgery will in addition be recorded. The above information will be collected from the patient's medical record.

Day 1, day 7, day 21, 3 months (after surgery)
Perioperative complications
大体时间:1 day During admission (after surgery)

Complications which happens during surgery.

1 day During admission (after surgery)
Length of stay/ Re-admissions within the first 90 days
大体时间:90 days (after surgery)

The patients are expected to be discharged on day 1 post-surgery after a blood sample is taken at 24 hours post-surgery. It will be recorded if a patient is not able to be discharged at this time and for how many days the admission will last. The number of readmissions within 90 days of surgery and the reason for re-admission will also be recorded. This information will be collected from the patient's medical journal.

90 days (after surgery)
90 days complications (medical, surgical)
大体时间:90 days (after surgery)

Complications (both medical and surgical) arising within 90 days of surgery will be recorded. The information will be collected from the patient's medical records.

Complications includes myocardial infarction/cardiac events, cerebrovascular events, venous thromboembolism, deep infection, reoperation, revision, and death.

90 days (after surgery)
Data on any revisions performed on includes patient within 24 months
大体时间:24 months (after surgery)

Any revisions in patients within 24 months will be recorded. The reason for revision and the type of revision will be noted. The information will be collected from the patient's medical records.

24 months (after surgery)
Pain Catastrophizing Scale (PCS)
大体时间:Baseline

The Pain Catastrophizing Scale (PCS) is a 13-item patient reported outcome measure developed to evaluate catastrophic thinking related to pain. Standardized answer options are given through a 5-point Likert scales, from 0 (not at all) to 4 (all the time). Higher scores indicate higher level of catastrophizing. A total score yielding (ranging from 0-52), along with three subscale scores assessing rumination, magnification, and helplessness.

Baseline
Pain Detect Questionnaire (PDQ)
大体时间:Baseline

The PDQ is a patient administered questionnaire used to assess the likelihood of a pain experience being of neuropathic origin.

Baseline
Oxford Knee Score (OKS)
大体时间:Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)

The Oxford Knee Score (OKS) is a 12-item patient reported outcome questionnaire developed specifically to assess the patient's perspective on the outcomes of knee arthroplasty with respect to combined pain and physical function. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. Thus, a total score is calculated from 0 to 48, with 48 indication the best outcome. The OKS is short, practical, reliable, valid, and sensitive to clinically important changes over time18.

Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)
The Forgotten Joint Score
大体时间:Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)

The Forgotten Joint Score was designed to assess patient outcome in patients undergoing conservative or operative treatment of the knee, and it analyses patient's ability to forget about a joint as a result of successful treatment. The questionnaire consists of 12 questions that are equally weighted and measure patient satisfaction. Standardized answer options are given (6 Likert boxes). Scores are summed to create a composite score that is converted to a 100-point scale. Higher scores indicate greater satisfaction.

Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)
European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
大体时间:Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)

EQ-5D-5L is a standardized patient-reported instrument for measurement of health outcome and quality of life. EQ-5D-5L is designed for self-completion by respondents and is ideally suited for use in surveys. The EQ-5D-5L consists of 2 pages - the EQ-5D-5L description system and the EQ Visual Analogue Scale (EQ VAS). The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Standardized answer options are given (5 22.12.2022 Page 17 of 30 Likert boxes) and each question is assigned a score from 1 to 5. Instructions to respondents are included in the questionnaire. The EQ VAS records the respondent's self-rated health on a 20 visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine". This information can be used as a quantitative measure of health judged by the individual respondents.

Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)
Patient acceptable Symptom States (PASS)
大体时间:3 months, 6 months, 12 months, 24 months (after surgery)

One question regarding PASS will be used to assess how many patients consider themselves well after surgery (as opposed to feeling better). PASS is assessed as a dichotomous outcome (yes/no) to the question:"Taking into account all the activities you have during your daily life, your level of pain, and also your functional impairment, do you consider that your current state is satisfactory?". The actual question asked will be in Danish (Appendix G).

3 months, 6 months, 12 months, 24 months (after surgery)
Treatment failure (TF)
大体时间:3 months, 6 months, 12 months, 24 months (after surgery)

We will define treatment failure in two ways:

  1. Patients replying 'no' to the PASS question (above) will be asked to answer (yes/no) the following question: "Would you consider your current state as being so unsatisfactory that you think the treatment has failed?" Patients replying, 'yes' to this second question will be defined as experiencing 'treatment failure' (TF).
  2. Patients who during the observation period undergo revision surgery are defined as TF. We will seek information about the reason for revision surgery (e.g. infection, malalignment, loosening/lysis, implant wear, dislocation/instability, stiffness, pain, and other reasons) in the medical records.
3 months, 6 months, 12 months, 24 months (after surgery)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Anders Troelsen, MD, PhD, DMSc、Department of Orthopaedic Surgery, Amager Hvidovre Hospital, Kettegård Alle 30, DK-2650 Hvidovre

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年2月20日

初级完成 (实际的)

2024年3月30日

研究完成 (实际的)

2026年2月28日

研究注册日期

首次提交

2023年1月30日

首先提交符合 QC 标准的

2023年2月17日

首次发布 (实际的)

2023年2月21日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

No plan

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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