CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 311 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT01320150
NCT01320150N/ACompleted

Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement

Rush University Medical Center·observational·Posted Mar 22, 2011·Updated Sep 23, 2021

In Brief

An observational study for Persistent Postsurgical Pain. Completed, enrolled 311 participants across 1 site.

Detailed 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 postoperative phases of TKR that contribute to PPP at 6 months. Specific risk factors were selected because they are potentially modifiable, and therefore may be amenable to intervention. Patients will be assessed from pre-surgery to 6 months post surgery. The proposed multi-factorial and prospective approach to investigating risk factors is a vital next step towards understanding the complex phenomenon of PPP.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsPfizer

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2011
Enrollment StartMar 1, 2011
Primary CompletionAug 1, 2017
Study CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 15.3 years ago