Pain+Stiffness: Persistent Postoperative Pain and Joint Stiffness After Total Knee Arthroplasty Performed for Osteoarthritis
Study Details
Study Description
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 | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- 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
Secondary Outcome Measures
- Incidence of postoperative joint stiffness [6 weeks after date of surgery]
Number of patients that experience postoperative joint stiffness, defined as ≤95 degrees range of motion.
- 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.
- 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.
- 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 POD1 [1 day after surgery]
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.
- NRS pain at rest on POD2 [2 days after surgery]
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 on POD2 [2 days after surgery]
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.
- Worst NRS pain on POD2 [2 days after surgery]
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.
- Least NRS pain on POD2 [2 days after surgery]
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.
- NRS pain at rest 4 weeks after surgery [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.
- NRS pain with movement 4 weeks after surgery [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.
- Worst NRS pain 4 weeks after surgery [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.
- Least NRS pain 4 weeks after surgery [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.
- NRS pain at rest 3 months after surgery [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.
- NRS pain with movement 3 months after surgery [6 weeks after date of 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.
- Worst NRS pain 3 months after surgery [6 weeks after date of 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.
- Least NRS pain 3 months after surgery [6 weeks after date of 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.
- NRS pain at rest 6 months after surgery [6 weeks 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.
- Least NRS pain 6 months after surgery [6 weeks 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.
- Worst NRS pain 6 months after surgery [6 weeks 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.
- Postoperative knee range of motion [6 weeks after date of surgery]
Range of motion (extension minus flexion) at patients postoperative 6 week appointment. Measured by the surgeon or surgical staff. Measured in degrees.
- Postoperative KOOS scores [4 weeks, 3 months, and 6 months after date of surgery]
- Postoperative painDETECT scores [4 weeks, 3 months, and 6 months after date of surgery]
Neuropathic pain assessment
- Time to attainment of inpatient physical therapy goals [During inpatient hospital stay, approximately 3 days after date of surgery]
Goals include ambulation of 40 feet and independent transfer.
- Types of postoperative medications [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Elective primary unilateral total knee arthroplasty
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Osteoarthritis with radiologic evidence of "severe narrowing" and/or "bone on bone" in the affected joint
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Patients of surgeons who have agreed to participate in the study
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Age > 18 years
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American Society of Anesthesiologists (ASA) Physical Status 1-3
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Regional anesthesia
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Epidural patient-controlled analgesia (PCA) for postoperative pain
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Adductor canal block for postoperative pain
Exclusion Criteria:
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Contraindication to regional anesthesia, NSAIDs, dexamethasone or acetaminophen
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Use of general anesthesia
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History of >6 weeks of daily opioid use and/or any use of non-prescribed opioids
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Preoperative oral steroid use in the past 6 months
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Intra-articular steroid injection within one month of scheduled surgery in affected joint
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Non-English speakers
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Pre-existing diagnosis of rheumatic disease or autoimmune disease (e.g. rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, multiple sclerosis, Type I diabetes)
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Peri-articular injections or infusions for postoperative pain
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Diagnosis of crystalline arthropathy
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Diagnosis of osteonecrosis
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Active infection or use of antibiotics
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Pregnant women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital for Special Surgery | New York | New York | United States |
Sponsors and Collaborators
- Hospital for Special Surgery, New York
Investigators
- Principal Investigator: Meghan Kirksey, MD, PhD, Hospital for Special Surgery, New York
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015-361