Change of Cognitive Performance Through Hip Replacement

Study Overview
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Brief Summary
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The purpose of this study is to investigate the effectiveness of a hip arthroplasty for chronic pain, caused by a unilateral primary Coxartrhrose, regarding the cognitive performance. It is based on the hypothesis that the combination of chronic pain along with relative immobilization causes impairment of cognitive performance. The total hip replacement reduces pain, increases the mobility level and finally improves the cognitive performance.

Detailed Description
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Studies have shown that cognitive performance, especially in the elderly is limited due to chronic pain. In a recent study, significantly less brain activity in various regions of the brain (the anterior cingulate cortex (ACC), insula and operculum, dorsolateral prefrontal cortex and orbitofrontal cortex) was detected in patients with unilateral primary coxarthrosis compared to a healthy control group. After eliminating the pain by the implantation of a total hip replacement, a significant increase in brain activity in the affected areas was observed in these patients. Whether this observation is accompanied by an effect on cognition, is not known and will be investigated in the proposed study. The purpose of this study is to investigate the effectiveness of a hip arthroplasty for chronic pain, caused by a unilateral primary Coxartrhrose, regarding the cognitive performance. It is based on the hypothesis that the combination of chronic pain along with relative immobilization causes impairment of cognitive performance. The total hip replacement reduces pain, increases the mobility level and finally improves the cognitive performance. The main issue concerns the short and mid-term influence of hip replacement on cognitive performance in the perioperative care continuum in comparison to a control group that does not have chronic pain. To objectively quantify the everyday activity, there are a variety of instruments, without a currently gold standard. Therefore, in addition the investigators use objectified measurement parameters with the aid of a pedometer (GARMIN vivofit) on every three measuring time points (before surgery, 3 months after surgery, 6 months after surgery). Standardized neuropsychological assessment methods are used to assess the cognitive performance. To assess the degree of mobility, health status and the physical activity standardized questionnaires are used. Primary hypothesis: After implantation of an artificial hip replacement and reduction of experienced pain patients with primary coxarthrosis indicate an improvement of cognitive performance 3 and 6 month after surgery compared to the pre-surgical status. In addition, the investigators measure how severe the cognitive performance is reduced compared to a healthy control group prior to surgery and to what extend the cognitive performance is reversible in the aftermath.

Official Title
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Change of Cognitive Performance for Older People Through Artificial Hip Replacement Implantation [German Title: Veränderungen Der Kognitiven Leistungsfähigkeit älterer Menschen Durch Hüft-TEP Implantation]

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Diagnostic Test: everyday activity
* Diagnostic Test: cognitive performance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary, unilateral coxarthrosis planning for hip replacement surgery in Bad Bramstedt Exclusion Criteria: dementia / cognitive impairment (Mini Mental Status Test <25) chronic pain otherwise genesis reduced physical activity otherwise genesis lack of German language skills uncorrected serious impairment of vision or hearing serious additional psychiatric diagnoses (e.g. substance abuse / addiction)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intervention group<br>Patients with primary, unilateral hip osteoarthritis in inpatient orthopedic acute treatment, who have a medical indication of a necessary artificial hip replacement implantation. | Diagnostic Test: everyday activity<br>* To objectively quantify the everyday activity, there are a variety of instruments, without a currently gold standard. Therefore, in addition the investigators use objectified measurement parameters with the aid of a pedometer (GARMIN vivofit) on every three measuring time points (before surgery, 3 months after surgery, 6 months after surgery).<br>Diagnostic Test: cognitive performance<br>* Standardized neuropsychological assessment methods are used to assess the cognitive performance. To assess the degree of mobility, health status and the physical activity standardized questionnaires are used.<br>|
| control group<br>Volunteers without chronic pain. As a control condition for comparing the variation in cognitive performance and everyday activity the investigators use a group of pain-free and mobility-unrestricted subjects, who do not receive or have an artificial hip. | Diagnostic Test: everyday activity<br>* To objectively quantify the everyday activity, there are a variety of instruments, without a currently gold standard. Therefore, in addition the investigators use objectified measurement parameters with the aid of a pedometer (GARMIN vivofit) on every three measuring time points (before surgery, 3 months after surgery, 6 months after surgery).<br>Diagnostic Test: cognitive performance<br>* Standardized neuropsychological assessment methods are used to assess the cognitive performance. To assess the degree of mobility, health status and the physical activity standardized questionnaires are used.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| attention and concentration performance (assessed by d2 Test of Attention) |  | Change from Baseline attention and concentration performance at 6 months | 
| conceptual tracking, planning and flexibility (assessed by Trail Making Tests (Parts A and B) |  | Change from Baseline conceptual tracking, planning and flexibility at 6 months | 
| semantic memory (assessed by FAS-Test [Verbal Fluency]) |  | Change from Baseline semantic memory at 6 months | 
| verbal episodic memory (Rivermead Behavioural Memory Test (RBMT) - story recall subtest) subtest |  | Change from Baseline verbal episodic memory at 6 months | 
| visuospatial constructional ability and visual memory (assessed by Rey-Osterrieth Complex Figure Test) |  | Change from Baseline visuospatial constructional ability and visual memory at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective physical activity (assessed by Physical Activity Scale for the Elderly (PASE)) |  | Change from Baseline subjective physical activity at 6 months | 
| objective physical activity (assessed by pedometer GARAMIN vivofit) |  | Change from Baseline objective physical activity at 6 months | 
| anxiety (assessed by the Generalized Anxiety Disorder 7-Scale (GAD-7)) |  | Change from Baseline anxiety at 6 months | 
| depression (assessed by the Patient Health Questionnaire (PHQ-9)) |  | Change from Baseline depression at 6 months | 
| quality of life (assessed by the SF-12 health survey) |  | Change from Baseline quality of life at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cognition, hip replacement, physical activity, quality of life, psychological distress