Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01320150
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2011-03-18
Brief Title:
Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Risk Factors and Mechanisms for Persistent Postsurgical Pain After Total Knee Replacement
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PPP-TKA
Brief 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 65000-100000 patientsyear 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 andor 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 cognitiveaffective 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
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 andor 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 cognitiveaffective 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
Detailed Description:
Overall Strategy The primary aim of this application is to investigate relationships of risk factors to the development of persistent postoperative pain PPP at 6 mo following TKR through independently predictive and mediated models
These risk factors are preoperative thermal pain sensitivity pain anxiety and catastrophizing postoperative area of secondary mechanical hyperalgesia or hypoalgesia numbness and pain intensity PPP for this study will be defined as pain in the operated knee at six months after TKR with other causes of pain excluded and reported intensity on 0-10 Numerical Response Scale NRS scale of 4 The study will also evaluate the relationship of PPP incidence with the severity of functional impairment This is a single-site prospective clinical investigation of 300 consented OA patients undergoing primary unilateral TKR
These risk factors are preoperative thermal pain sensitivity pain anxiety and catastrophizing postoperative area of secondary mechanical hyperalgesia or hypoalgesia numbness and pain intensity PPP for this study will be defined as pain in the operated knee at six months after TKR with other causes of pain excluded and reported intensity on 0-10 Numerical Response Scale NRS scale of 4 The study will also evaluate the relationship of PPP incidence with the severity of functional impairment This is a single-site prospective clinical investigation of 300 consented OA patients undergoing primary unilateral TKR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None