Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Ost… (NCT02626533) | Clinical Trial Compass
CompletedNot Applicable
Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
United States179 participantsStarted 2015-12
Plain-language summary
Persistent pain and joint stiffness after surgery may interfere with recovery and adversely affect quality of life in up to 40% of patients who have undergone total knee arthroplasty. There is growing evidence that inflammation as well as other medical and psychological factors may be associated with osteoarthritis severity, progression, and associated pain severity. This study aims to identify clinical, biological, and psychological factors that contribute to and predict the development of these complications. Identification of such factors may allow us to target preventative measures to the patients at highest risk of persistent postoperative pain and joint stiffness.
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:
* Elective primary unilateral total knee arthroplasty
* Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
* Patients of surgeons who have agreed to participate in the study
* Age \> 18 years
* American Society of Anesthesiologists (ASA) Physical Status 1-3
* Regional anesthesia
* Epidural patient-controlled analgesia (PCA) for postoperative pain
* Adductor canal block for postoperative pain
Exclusion Criteria:
* Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
* Use of general anesthesia
* History of \>6 weeks of daily opioid use and/or any use of non-prescribed opioids
* Preoperative oral steroid use in the past 6 months
* Intra-articular steroid injection within one month of scheduled surgery in affected joint
* Non-English speakers
* Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
* Peri-articular injections or infusions for postoperative pain
* Diagnosis of crystalline arthropathy
* Diagnosis of osteonecrosis
* Active infection or use of antibiotics
* Pregnant women
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.
What they're measuring
1
Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)