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

Completed

Conditions: Pain
Joint Stiffness

Interventions: Procedure: Total Knee Arthroplasty

Registration Number: NCT02626533

Lead Sponsor: Hospital for Special Surgery, New York

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 179

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Total knee arthroplasty patients	Total Knee Arthroplasty	Patients undergoing total knee arthroplasty for osteoarthritis are enrolled in the study. Blood and joint fluid samples will be obtained from patients. Pain type and severity will be assessed at baseline (enrollment), 4 weeks, 3 months, and 6 months postoperatively.

Primary Outcome Measures

Name	Time	Method
Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)	6 months after date of surgery	Defined as numeric rating scale (NRS) pain score ≥4 with activity in the operated joint. A lower score is a better outcome. 0 is no pain, and 10 is worst pain imaginable.

Secondary Outcome Measures

Name	Time	Method
Patients Who Experienced Postoperative Joint Stiffness	6 weeks after date of surgery	The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion.
NRS Pain at Rest on POD1	1 day after surgery	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.
NRS Pain With Movement on POD1	1 day after surgery	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.
NRS Pain at Rest 4 Weeks After Surgery	4 weeks after surgery	Numerical rating scale (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.
NRS Pain at Rest 3 Months After Surgery	3 months after surgery	Numerical rating scale (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.
Worst NRS Pain 3 Months After Surgery	3 months after date of surgery	Worst numerical rating scale (NRS) pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. The average worst NRS pain for all participants who completed the survey at 3 months is reported.
Postoperative Knee Range of Motion	6 weeks after date of surgery	Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.
Worst NRS Pain on POD1	1 day after surgery	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.
Least NRS Pain on POD2	2 days after surgery	Least numerical rating scale (NRS) pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
NRS Pain With Movement 3 Months After Surgery	3 months after surgery	Numerical rating scale (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. The average NRS pain for all participants who completed the survey at 3 months is reported.
NRS Pain With Movement on POD2	2 days after surgery	Numerical rating scale (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.
NRS Pain at Rest 6 Months After Surgery	6 months after date of 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. The average NRS pain at rest for all participants who completed the survey at 6 months is reported.
Worst NRS Pain on POD2	2 days after surgery	Worst numerical rating scale (NRS) pain on postoperative day 2, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Worst NRS Pain 4 Weeks After Surgery	4 weeks after surgery	Worst numerical rating scale (NRS) pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Least NRS Pain 3 Months After Surgery	3 months after date of surgery	Least numerical pain rating (NRS) pain 3 months postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable. The average least NRS pain for all participants who completed the survey at 3 months is reported.
Least NRS Pain on POD1	1 day after surgery	Least numerical rating scale (NRS) pain on postoperative day 1, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
NRS Pain at Rest on POD2	2 days after surgery	Numerical rating scale (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.
NRS Pain With Movement 4 Weeks After Surgery	4 weeks after surgery	Numerical rating scale (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.
Least NRS Pain 4 Weeks After Surgery	4 weeks after surgery	Least numerical rating scale (NRS) pain 4 weeks postoperative, measured from 0-10, with 0 being no pain at all to 10 being the worst pain imaginable.
Least NRS Pain 6 Months After Surgery	6 months after date of 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. The average least NRS pain for all participants who completed the survey at 6 months is reported.
Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores	4 weeks, 3 months, and 6 months after date of surgery	The Knee Injury and Osteoarthritis Outcome Score (KOOS) is a knee-specific instrument, developed to assess the patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A higher score is a better outcome. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems. Although collected at different timepoints, the average score for each participant is calculated and then the average score for all patients is reported.
Postoperative painDETECT Scores	4 weeks, 3 months, and 6 months after date of surgery	PainDETECT is a 9-item self-report screening questionnaire developed to detect NeP in conditions like chronic low back pain. PD-Q measures 7 aspects of the quality of the pain experienced, the chronological pattern (time course), and whether or not the pain radiates. It is scored from 0 to 38, with total scores of \<12 considered = nociceptive pain, 13-18 = possible NeP, and \>19 = \>90% likelihood of NeP. A lower score is a better outcome. Although measured at multiple time points, the average score for each participant is analyzed, and then the average scores for all participants is calculated and reported.
Types of Preoperative Medications	Before surgery	Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.
Worst NRS Pain 6 Months After Surgery	6 months after date of 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. The average worst NRS pain for all participants who completed the survey at 6 months is reported.