Surgery Induced Trauma After Total Versus Medial Unicompartmental Knee Arthroplasty (SITA) (NCT05735847) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Surgery Induced Trauma After Total Versus Medial Unicompartmental Knee Arthroplasty (SITA)
Denmark29 participantsStarted 2023-02-20
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.