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
|Condition or disease||Intervention/treatment|
|Pain Joint Stiffness||Procedure: Total Knee Arthroplasty|
|Study Type :||Observational|
|Estimated Enrollment :||186 participants|
|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|
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.
- 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
- Incidence of postoperative joint stiffness [ Time Frame: 6 weeks after date of surgery ]Defined as range of motion (ROM)≤95 degrees
- Postoperative NRS Pain scores [ Time Frame: 1 day, 2 days, 4 weeks, 3 months, and 6 months after date of surgery ]
- Postoperative knee ROM [ Time Frame: 6 weeks after date of surgery ]
- Postoperative KOOS scores [ Time Frame: 4 weeks, 3 months, and 6 months after date of surgery ]
- Postoperative painDETECT scores [ Time Frame: 4 weeks, 3 months, and 6 months after date of surgery ]Neuropathic pain assessment
- 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.
- 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
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
|Contact: Katherine Leeemail@example.com|
|Contact: Denesy Mancenidofirstname.lastname@example.org|
|United States, New York|
|Hospital for Special Surgery||Recruiting|
|New York, New York, United States|
|Contact: Meghan Kirksey email@example.com|
|Principal Investigator:||Meghan Kirksey, MD, PhD||Hospital for Special Surgery, New York|