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NCT01320150 · ClinicalTrials.gov registry record
Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement
A clinical trial, sponsored by Rush University Medical Center.
- Completed
- Registry status
- 311
- Enrollment target
NCT01320150: Completed study, sponsored by Rush University Medical Center.
NCT01320150 is a clinical trial that has completed, run by Rush University Medical Center. The registered enrollment target is 311 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01320150 has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- 311 participants
- Enrollment target
Study Summary
Osteoarthritis (OA) is the single most common cause of disability in mid and late life. About 27 million people in the United States suffer from this incurable process and 10 million have OA of the knee. Total knee replacement (TKR) is a reliable treatment option for patients disabled by knee OA who have failed non-operative treatment; 58% of these surgeries are performed on patients 65 years or older. Despite the overall success of TKR in most cases, persistent postsurgical pain (PPP) of the operated knee remains a common and often difficult to treat postoperative outcome affecting 13-20% of all patients at 6 months post-TKR, which amounts to 65,000-100,000 patients/year in the USA. Important secondary outcomes of PPP are restricted physical mobility and poor quality of life, especially in older patients. Recent findings spanning the pre-, intra- and postoperative periods suggest that the development of PPP after TKR is a multi-factorial process, comprised of both neurophysiologic and psychosocial factors. Likely determinates include preoperative thermal pain sensitivity, anxiety, pain catastrophizing; and postoperative area of secondary mechanical hyperalgesia or hypoalgesia (numbness). There is already agreement that the intensity of early (acute) postoperative pain is one of the factors predicting PPP. To date, most studies have examined the role of risk factors in isolation and/or within a single domain, and no prospective study has comprehensively evaluated the interaction of neurophysiologic and psychosocial variables in the evolution of PPP following TKR. The lack of information regarding how neurophysiologic pathways and patient cognitive/affective states interact over time following otherwise successful TKR has greatly undermined the understanding of PPP after TKR. The proposed project is a single-site, prospective study of 300 OA patients aged 18-85 yrs undergoing primary TKR. The study is designed to identify factors from the pre-, intra- and postopera
Primary Outcome
PPP for this study will be defined as "pain in the operated knee at six months after Total Knee Replacement surgery, with other causes of pain excluded, and a reported intensity on 0-10 Numerical Response Scale (NRS) of ≥4 where higher pain scores indicate higher levels of pain. NRS scores range from 0 {No Pain} to 10 {Worst Imaginable Pain}.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 311 participants |
| Start Date | 2011-03 |
| Est. Completion | 2018-04 |
What the finished NCT01320150 record still lists
NCT01320150 is an observational study that tracks outcomes without assigning an intervention. The registered 311 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01320150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01320150 about?
NCT01320150 is a clinical study titled "Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement". Osteoarthritis (OA) is the single most common cause of disability in mid and late life. About 27 million people in the United States suffer from this incurable process and 10 million have OA of the knee. Total knee replacement (TKR) is a reliable treatment option for patients disabled by knee OA who...
What is the current status of trial NCT01320150?
This trial is currently completed. The enrollment target is 311 participants. The study started on 2011-03. Estimated completion is 2018-04.
Who is sponsoring clinical trial NCT01320150?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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