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슬관절 전치환술 대 내측 단일구획 슬관절 치환술(SITA) 후 수술로 인한 외상 (SITA)

2026년 9월 17일 업데이트: Anders Troelsen, Hvidovre University Hospital

수술로 인한 외상이 전체 대 내측 단일구획 슬관절 치환술(SITA)을 비교한 수술 후 안전 및 결과에 영향을 미치는가: 전향적 코호트 연구

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.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

관찰

등록 (실제)

29

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

      • Hvidovre, 덴마크, 2650
        • Department of Orthopaedic Surgery, Amager Hvidovre Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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).

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: COHORT
  • 시간 관점: PROSPECTIVE

코호트 및 개입

그룹/코호트
개입 / 치료
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
C-reactive protein (CRP)
기간: Day 1 (24 hours after surgery)

Marker of systemic inflammation and soft tissue injury

Day 1 (24 hours after surgery)

2차 결과 측정

결과 측정
측정값 설명
기간
Interleukin-1-beta (IL1-beta)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Anders Troelsen, MD, PhD, DMSc, Department of Orthopaedic Surgery, Amager Hvidovre Hospital, Kettegård Alle 30, DK-2650 Hvidovre

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 2월 20일

기본 완료 (실제)

2024년 3월 30일

연구 완료 (실제)

2026년 2월 28일

연구 등록 날짜

최초 제출

2023년 1월 30일

QC 기준을 충족하는 최초 제출

2023년 2월 17일

처음 게시됨 (실제)

2023년 2월 21일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 17일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • H-22029746

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

No plan

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

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미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .