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

Pain Clinical Trial

— Pain+Stiffness  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02626533
• Other study ID #: 2015-361
• Status: Active, not recruiting
• Start date: December 2015
• Est. completion date: July 2022

Study information

• Verified date: August 2021
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 179
• Est. completion date: July 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Joint Stiffness
• Osteoarthritis
• Pain
• Pain, Postoperative

Intervention

Procedure:
• Total Knee Arthroplasty
Patients will undergo total unilateral knee arthroplasty for osteoarthritis.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Postoperative KOOS scores		4 weeks, 3 months, and 6 months after date of surgery
Secondary	Postoperative painDETECT scores	Neuropathic pain assessment	4 weeks, 3 months, and 6 months after date of surgery
Secondary	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
Secondary	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