Knee OsteoarthritisSITANCT05735847
Surgery Induced Trauma After Total Versus Medial Unicompartmental Knee Arthroplasty (SITA)
An observational study of Knee Osteoarthritis and Arthritis, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Arthritis, Surgery
- What is being tested?
- Total Knee Arthroplasty (TKA) and Unicompartmental Knee Arthroplasty (UKA)
- Type of treatment
- Surgery or procedure
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Feb 2023to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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).
Who may be able to join
- Age 18 or more
- A clinical and radiological diagnosis of knee OA
- Candidate for spinal anaesthesia
- signed informed consent
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Orthopaedic Surgery, Amager Hvidovre Hospital
Hvidovre, 2650
About this study
Official title: Does Surgery-Induced Trauma Influence Postoperative Safety and Outcome Comparing Total vs. Medial Unicompartmental Knee Arthroplasty (SITA): A Prospective Cohort Study
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.
Read more
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.
- Conditions
- Knee Osteoarthritis, Arthritis, Surgery, Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty
- Being tested
- Total Knee Arthroplasty (TKA), Unicompartmental Knee Arthroplasty (UKA)
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee Arthroplasty (TKA)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Total Knee Arthroplasty (TKA) | |
| 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). Receives: Procedure: Unicompartmental Knee Arthroplasty (UKA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein (CRP)
Marker of systemic inflammation and soft tissue injury
Measured: Day 1 (24 hours after surgery)
Secondary outcomes (30)
Interleukin-1-beta (IL1-beta)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Interleukin-6 (IL6)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Interleukin-8 (IL8)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Tumor necrosis factor alfa (TNF-alfa)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Metalloproteinases (MMP3, MMP9, MMP13)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Calprotectin - S100 calcium binding protein A8/A9 (S100A8/S100A9)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
S100 calcium-binding protein B (S100B)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
C-Reactive Protein (CRP)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Haemoglobin (Hb)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Erythrocyte Sedimentation Rate (ESR)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
White cell count (L+D)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Platelets
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Myoglobin
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Lactate dehydrogenase (LDH)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Creatine Kinase (CK)
Marker of systemic inflammation and soft tissue injury
Measured: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Duration of surgery in minutes
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.
Measured: Within the first week after surgery
Postoperative x-rays
Postoperative x-rays of the knee are performed routinely in order to evaluate whether implants are placed in accordance with recommendations.
Measured: On day of surgery, or postoperative day 1, or postoperative day 2
Knee pain (VAS)
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.
Measured: Day 1, day 7, day 21, 3 months, 6 months, 12 months, 24 months (after surgery)
Analgesia requirements 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.
Measured: Day 1, day 7, day 21, 3 months (after surgery)
Perioperative complications
Complications which happens during surgery.
Measured: 1 day During admission (after surgery)
Length of stay/ Re-admissions within the first 90 days
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.
Measured: 90 days (after surgery)
90 days complications (medical, surgical)
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.
Measured: 90 days (after surgery)
Data on any revisions performed on includes patient within 24 months
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.
Measured: 24 months (after surgery)
Pain Catastrophizing Scale (PCS)
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.
Measured: Baseline
Pain Detect Questionnaire (PDQ)
The PDQ is a patient administered questionnaire used to assess the likelihood of a pain experience being of neuropathic origin.
Measured: Baseline
Oxford Knee Score (OKS)
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.
Measured: Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)
The Forgotten Joint Score
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.
Measured: Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)
European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
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.
Measured: Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)
Patient acceptable Symptom States (PASS)
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).
Measured: 3 months, 6 months, 12 months, 24 months (after surgery)
Treatment failure (TF)
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.
Measured: 3 months, 6 months, 12 months, 24 months (after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start20 Feb 2023
- Primary completion30 Mar 2024
- Study completion28 Feb 2026
Why it stopped: The study was terminated due to poor participant accrual. Recruitment was limited by competing clinical studies at the participating site, and the resources required to prolong the recruitment period were not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Frederiksberg University Hospital, Parker Research Institute
- Responsible party
- Principal investigator, Anders Troelsen, Hvidovre University Hospital
- Investigators
- Anders Troelsen, MD, PhD, DMSc, Principal investigator, Department of Orthopaedic Surgery, Amager Hvidovre Hospital, Kettegård Alle 30, DK-2650 Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735847
- Sponsor's protocol ID
- H-22029746
- Acronym
- SITA
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Surgery-Induced Trauma Influence Postoperative Safety and Outcome Comparing Total vs. Medial Unicompartmental Knee Arthroplasty (SITA): A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05735847
- Acronym / sponsor ID
- SITA / H-22029746
- Conditions
- Knee Osteoarthritis, Arthritis, Surgery, Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated due to poor participant accrual. Recruitment was limited by competing clinical studies at the participating site, and the resources required to prolong the recruitment period were not available.
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Frederiksberg University Hospital, Parker Research Institute
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total Knee Arhroplasty (TKA) | – | Procedure: Total Knee Arthroplasty (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). |
| Unicompartmental Knee Arthroplasty (UKA) | – | Procedure: 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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).
Key inclusion criteria (4 listed)
- Age 18 or more
- A clinical and radiological diagnosis of knee OA
- Candidate for spinal anaesthesia
- signed informed consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Total Knee Arhroplasty (TKA) |
| 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. | Procedure or surgery | Unicompartmental Knee Arthroplasty (UKA) |
Primary outcome
C-reactive protein (CRP)
Time frame: Day 1 (24 hours after surgery)
Marker of systemic inflammation and soft tissue injury
30 secondary outcomes
Interleukin-1-beta (IL1-beta)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Interleukin-6 (IL6)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Interleukin-8 (IL8)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Tumor necrosis factor alfa (TNF-alfa)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Metalloproteinases (MMP3, MMP9, MMP13)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Calprotectin - S100 calcium binding protein A8/A9 (S100A8/S100A9)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
S100 calcium-binding protein B (S100B)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
C-Reactive Protein (CRP)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Haemoglobin (Hb)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Erythrocyte Sedimentation Rate (ESR)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
White cell count (L+D)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Platelets
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Myoglobin
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Lactate dehydrogenase (LDH)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Creatine Kinase (CK)
Time frame: Baseline, 2 hours, 1 day, 7 days, and 21 days (after surgery)
Duration of surgery in minutes
Time frame: Within the first week after surgery
Postoperative x-rays
Time frame: On day of surgery, or postoperative day 1, or postoperative day 2
Knee pain (VAS)
Time frame: Day 1, day 7, day 21, 3 months, 6 months, 12 months, 24 months (after surgery)
Analgesia requirements after surgery
Time frame: Day 1, day 7, day 21, 3 months (after surgery)
Perioperative complications
Time frame: 1 day During admission (after surgery)
Length of stay/ Re-admissions within the first 90 days
Time frame: 90 days (after surgery)
90 days complications (medical, surgical)
Time frame: 90 days (after surgery)
Data on any revisions performed on includes patient within 24 months
Time frame: 24 months (after surgery)
Pain Catastrophizing Scale (PCS)
Time frame: Baseline
Pain Detect Questionnaire (PDQ)
Time frame: Baseline
Oxford Knee Score (OKS)
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)
The Forgotten Joint Score
Time frame: Baseline, 3 months, 6 months, 12 months, 24 months (after surgery)
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)
Patient acceptable Symptom States (PASS)
Time frame: 3 months, 6 months, 12 months, 24 months (after surgery)
Treatment failure (TF)
Time frame: 3 months, 6 months, 12 months, 24 months (after surgery)
Results and safety
The study was stopped early (reason given: The study was terminated due to poor participant accrual. Recruitment was limited by competing clinical studies at the participating site, and the resources required to prolong the recruitment period were not available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Troelsen, MD, PhD, DMSc principal investigator
Department of Orthopaedic Surgery, Amager Hvidovre Hospital, Kettegård Alle 30, DK-2650 Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Arthritis, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to poor participant accrual. Recruitment was limited by competing clinical studies at the participating site, and the resources required to prolong the recruitment period were not available.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
C-reactive protein (CRP) (time frame: Day 1 (24 hours after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.