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Completed

NCT Number: NCT02626533

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

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.

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Key information

Conditions

Pain Joint Stiffness Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total knee arthroplasty

Procedure

Patients will undergo total unilateral knee arthroplasty for osteoarthritis.

Primary outcomes

  1. Presence of Persistent Postoperative Pain Using the Numeric Rating Scale (NRS)

    Time frame: 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 outcomes

  1. Patients Who Experienced Postoperative Joint Stiffness

    Time frame: 6 weeks after date of surgery

    The number of patients that experienced postoperative joint stiffness, defined as ≤95 degrees range of motion.

  2. Postoperative Knee Range of Motion

    Time frame: 6 weeks after date of surgery

    Range of motion at 6 weeks postoperative. Measured as flexion minus extension. Measured in degrees.

  3. NRS Pain at Rest on POD1

    Time frame: 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.

  4. NRS Pain With Movement on POD1

    Time frame: 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.

  5. Worst NRS Pain on POD1

    Time frame: 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.

  6. Least NRS Pain on POD1

    Time frame: 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.

  7. NRS Pain at Rest on POD2

    Time frame: 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.

  8. NRS Pain With Movement on POD2

    Time frame: 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.

  9. Worst NRS Pain on POD2

    Time frame: 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.

  10. Least NRS Pain on POD2

    Time frame: 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.

  11. NRS Pain at Rest 4 Weeks After Surgery

    Time frame: 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.

  12. NRS Pain With Movement 4 Weeks After Surgery

    Time frame: 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.

  13. Worst NRS Pain 4 Weeks After Surgery

    Time frame: 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.

  14. Least NRS Pain 4 Weeks After Surgery

    Time frame: 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.

  15. NRS Pain at Rest 3 Months After Surgery

    Time frame: 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.

  16. NRS Pain With Movement 3 Months After Surgery

    Time frame: 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.

  17. Worst NRS Pain 3 Months After Surgery

    Time frame: 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.

  18. Least NRS Pain 3 Months After Surgery

    Time frame: 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.

  19. NRS Pain at Rest 6 Months After Surgery

    Time frame: 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.

  20. Least NRS Pain 6 Months After Surgery

    Time frame: 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.

  21. Worst NRS Pain 6 Months After Surgery

    Time frame: 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.

  22. Postoperative Knee Injury and Osteoarthritis Outcome (KOOS) Scores

    Time frame: 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.

  23. Postoperative painDETECT Scores

    Time frame: 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.

  24. Types of Preoperative Medications

    Time frame: Before surgery

    Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Dec 10, 2015
Registry last updated
Dec 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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