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NCT Number: NCT05735847

Surgery Induced Trauma After Total Versus Medial Unicompartmental Knee Arthroplasty (SITA)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Surgery Total Knee Arthroplasty Unicompartmental Knee Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Orthopaedic Surgery, Amager Hvidovre Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total knee arthroplasty (TKA)

Procedure

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)

Procedure

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.

Primary outcomes

  1. C-reactive protein (CRP)

    Time frame: Day 1 (24 hours after surgery)

    Marker of systemic inflammation and soft tissue injury

Secondary outcomes

  1. Interleukin-1-beta (IL1-beta)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  2. Interleukin-6 (IL6)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  3. Interleukin-8 (IL8)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  4. Tumor necrosis factor alfa (TNF-alfa)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  5. Metalloproteinases (MMP3, MMP9, MMP13)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  6. Calprotectin - S100 calcium binding protein A8/A9 (S100A8/S100A9)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  7. S100 calcium-binding protein B (S100B)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  8. C-Reactive Protein (CRP)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  9. Haemoglobin (Hb)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  10. Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  11. White cell count (L+D)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  12. Platelets

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  13. Myoglobin

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  14. Lactate dehydrogenase (LDH)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  15. Creatine Kinase (CK)

    Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)

    Marker of systemic inflammation and soft tissue injury

  16. Duration of surgery in minutes

    Time frame: 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.

  17. Postoperative x-rays

    Time frame: 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.

  18. Knee pain (VAS)

    Time frame: 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.

  19. Analgesia requirements after surgery

    Time frame: 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.

  20. Perioperative complications

    Time frame: 1 day During admission (after surgery)

    Complications which happens during surgery.

  21. Length of stay/ Re-admissions within the first 90 days

    Time frame: 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.

  22. 90 days complications (medical, surgical)

    Time frame: 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.

  23. Data on any revisions performed on includes patient within 24 months

    Time frame: 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. Pain Catastrophizing Scale (PCS)

    Time frame: 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.

  25. Pain Detect Questionnaire (PDQ)

    Time frame: Baseline

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

  26. Oxford Knee Score (OKS)

    Time frame: 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.

  27. The Forgotten Joint Score

    Time frame: 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.

  28. European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)

    Time frame: 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.

  29. Patient acceptable Symptom States (PASS)

    Time frame: 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).

  30. Treatment failure (TF)

    Time frame: 3 months, 6 months, 12 months, 24 months (after surgery)

    We will define treatment failure in two ways:

    • 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).
    • 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.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Collaborators

  • Frederiksberg University Hospital
  • Parker Research Institute

Registry information

Official study title

Does Surgery-Induced Trauma Influence Postoperative Safety and Outcome Comparing Total vs. Medial Unicompartmental Knee Arthroplasty (SITA): A Prospective Cohort Study

Acronym: SITA

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Feb 21, 2023
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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