Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis

Study Overview
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Brief Summary
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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.

Official Title
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Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis

Conditions
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Pain, Joint Stiffness

Intervention / Treatment
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* Procedure: Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Total knee arthroplasty patients<br>Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients, and questionnaires will be administered to assess pain and stiffness. | Procedure: Total Knee Arthroplasty<br>* Patients will undergo total unilateral knee arthroplasty for osteoarthritis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of persistent postoperative pain using the numeric rating scale (NRS) | Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint | 6 months after date of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative joint stiffness | Number of patients that experience postoperative joint stiffness, defined as ≤95 degrees range of motion. | 6 weeks after date of surgery | 
| Postoperative knee range of motion | Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees. | 6 weeks after date of surgery | 
| NRS pain at rest on POD1 | NRS pain at rest on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 1 day after surgery | 
| NRS pain with movement on POD1 | NRS pain with movement on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 1 day after surgery | 
| Worst NRS pain on POD1 | Worst NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 1 day after surgery | 
| Least NRS pain on POD1 | Least NRS pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 1 day after surgery | 
| NRS pain at rest on POD2 | NRS pain at rest on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 2 days after surgery | 
| NRS pain with movement on POD2 | NRS pain with movement on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 2 days after surgery | 
| Worst NRS pain on POD2 | Worst NRS pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 2 days after surgery | 
| Least NRS pain on POD2 | Least NRS pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 2 days after surgery | 
| NRS pain at rest 4 weeks after surgery | NRS pain at rest on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 4 weeks after surgery | 
| NRS pain with movement 4 weeks after surgery | NRS pain with movement on 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 4 weeks after surgery | 
| Worst NRS pain 4 weeks after surgery | Worst NRS pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 4 weeks after surgery | 
| Least NRS pain 4 weeks after surgery | Least NRS pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 4 weeks after surgery | 
| NRS pain at rest 3 months after surgery | NRS pain at rest 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 3 months after surgery | 
| NRS pain with movement 3 months after surgery | NRS pain with movement 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 6 weeks after date of surgery | 
| Worst NRS pain 3 months after surgery | Worst NRS pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 6 weeks after date of surgery | 
| Least NRS pain 3 months after surgery | Least NRS pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 6 weeks after date of surgery | 
| NRS pain at rest 6 months after surgery | NRS pain at rest 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 6 weeks after date of surgery | 
| Least NRS pain 6 months after surgery | Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 6 weeks after date of surgery | 
| Worst NRS pain 6 months after surgery | Least NRS pain 6 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. | 6 weeks after date of surgery | 
| Postoperative knee range of motion | Range of motion (extension minus flexion) at patients postoperative 6 week appointment. Measured by the surgeon or surgical staff. Measured in degrees. | 6 weeks after date of surgery | 
| Postoperative KOOS scores |  | 4 weeks, 3 months, and 6 months after date of surgery | 
| Postoperative painDETECT scores | Neuropathic pain assessment | 4 weeks, 3 months, and 6 months after date of surgery | 
| Time to attainment of inpatient physical therapy goals | Goals include ambulation of 40 feet and independent transfer. | During inpatient hospital stay, approximately 3 days after date of surgery | 
| Types of postoperative medications | Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications. | 1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cytokines