Ignite Creation Date:
2024-05-06 @ 5:39 PM
Last Modification Date:
2024-10-26 @ 2:33 PM
Study NCT ID:
NCT05380648
Status:
COMPLETED
Last Update Posted:
2023-12-29
First Post:
2021-04-29
Brief Title:
Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis
Sponsor:
Universiteit Antwerpen
Organization:
Universiteit Antwerpen
Study Overview
Official Title:
Predicting Outcome of Total Knee Replacement Surgery in Patients With Knee Osteoarthritis a Prospective Study on the Role of Altered Central Pain Processing and Structural Functional Metabolic Inflammatory and Psychological Factors
Status:
COMPLETED
Status Verified Date:
2023-12
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:
None
Brief Summary:
Osteoarthritis OA is the main cause of pain and disability in elderly For knee OA a total knee replacement TKR is an effective surgical treatment and the majority of patients report substantial pain relief and functional improvement following surgery However 20-40 of patients undergoing TKR are dissatisfied with postsurgical outcome Even after revision some patients keep complaining of persisting pain
In this study the investigators will examine putative prognostic factors on the basis of the biopsychosocial model Besides several psychological factors measured with questionnaires the investigators will assess structural impairments such as radiographic severity of OA functional impairments muscle weakness and proprioceptive deficits anesthetic procedures immediate postoperative pain management metabolic factors body composition and hemoglobin A1c inflammatory factors C-Reactive Protein and the investigators also will examine the role of altered central pain processing CPP primary and secondary mechanical hyperalgesia mechanical temporal summation thermal primary and secondary hyperalgesia endogenous pain modulation
With a longitudinal study design this study will explore which factors are predictive of poor outcome in knee OA patients after TKR Moreover the interrelationship between CPP structural functional metabolic inflammatory and psychological factors and the clinical expression of knee OA pain symptoms physical performance and quality of life will be investigated
Further research on the role of the aforementioned putative prognostic factors on postsurgical outcome could contribute to better management of these patients since these factors may be particularly important for patient-tailored treatment
In this study the investigators will examine putative prognostic factors on the basis of the biopsychosocial model Besides several psychological factors measured with questionnaires the investigators will assess structural impairments such as radiographic severity of OA functional impairments muscle weakness and proprioceptive deficits anesthetic procedures immediate postoperative pain management metabolic factors body composition and hemoglobin A1c inflammatory factors C-Reactive Protein and the investigators also will examine the role of altered central pain processing CPP primary and secondary mechanical hyperalgesia mechanical temporal summation thermal primary and secondary hyperalgesia endogenous pain modulation
With a longitudinal study design this study will explore which factors are predictive of poor outcome in knee OA patients after TKR Moreover the interrelationship between CPP structural functional metabolic inflammatory and psychological factors and the clinical expression of knee OA pain symptoms physical performance and quality of life will be investigated
Further research on the role of the aforementioned putative prognostic factors on postsurgical outcome could contribute to better management of these patients since these factors may be particularly important for patient-tailored treatment
Detailed Description:
None
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