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

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ClinicalTrials.gov Identifier: NCT02626533
Recruitment Status : Recruiting
First Posted : December 10, 2015
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pain Joint Stiffness Procedure: Total Knee Arthroplasty

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Study Type : Observational
Estimated Enrollment : 186 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
Actual Study Start Date : December 2015
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Total knee arthroplasty patients
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
Patients will undergo total unilateral knee arthroplasty for osteoarthritis.




Primary Outcome Measures :
  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


Secondary Outcome Measures :
  1. Incidence of postoperative joint stiffness [ Time Frame: 6 weeks after date of surgery ]
    Defined as range of motion (ROM)≤95 degrees

  2. Postoperative NRS Pain scores [ Time Frame: 1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery ]
  3. Postoperative knee ROM [ Time Frame: 6 weeks after date of surgery ]
  4. Postoperative KOOS scores [ Time Frame: 4 weeks, 3 months, and 6 months after date of surgery ]
  5. Postoperative painDETECT scores [ Time Frame: 4 weeks, 3 months, and 6 months after date of surgery ]
    Neuropathic pain assessment

  6. Time to attainment of inpatient physical therapy goals [ Time Frame: During inpatient hospital stay, approximately 3 days after date of surgery ]
    Goals include ambulation of 40 feet and independent transfer.

  7. Types of postoperative medications [ Time Frame: 1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery ]
    Statin, gabapentinoid, anticonvulsant, selective serotonin reuptake inhibitor (SSRI), tricyclic antidepressant, serotonin norepinephrine reuptake inhibitor (SNRI), and opioid and non-opioid pain medications.


Biospecimen Retention:   Samples With DNA
Whole blood, serum, and joint fluid aspirate samples will be collected and stored for analysis.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital for Special Surgery patients scheduled to undergo unilateral total knee arthroplasty under regional anesthesia.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02626533


Contacts
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Contact: Katherine Lee 646-797-8948 leek@hss.edu
Contact: Denesy Mancenido 212-774-2602 mancenidod@hss.edu

Locations
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United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States
Contact: Meghan Kirksey       kirkseym@hss.edu   
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Meghan Kirksey, MD, PhD Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02626533     History of Changes
Other Study ID Numbers: 2015-361
First Posted: December 10, 2015    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hospital for Special Surgery, New York:
Cytokines

Additional relevant MeSH terms:
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Osteoarthritis
Pain, Postoperative
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms