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| Name | Class |
|---|---|
| Stiftung Endoprothetik | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention group | Patients with primary, unilateral hip osteoarthritis in inpatient orthopedic acute treatment, who have a medical indication of a necessary artificial hip replacement implantation. |
| |
| control group | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everyday activity | Diagnostic Test | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are enrolled in this study, who are diagnosed in the orthopedic clinic of Klinikum Bad Bramstedt or in the orthopedic clinic at University Medical Center Hamburg-Eppendorf. Study participants with the diagnosis of primary, unilateral coxarthrosis (ICD-10-GM: M16.1) are added consecutively in the intervention group, if they need a hip replacement because of their condition and decide to undergo this hip replacement in the orthopedic clinic of Klinikum Bad Bramstedt.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas Niemeier, Prof. Dr. | Contact | +49(0)40 7410 54745 | niemeier@uke.de | |
| Sönke Arlt, PD Dr. | Contact | +49 (0)40 7410 53437 | arlt@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Andreas Niemeier, Prof. Dr. | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Bad Bramstedt | Recruiting | Bad Bramstedt | 24576 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19889986 | Background | Rodriguez-Raecke R, Niemeier A, Ihle K, Ruether W, May A. Brain gray matter decrease in chronic pain is the consequence and not the cause of pain. J Neurosci. 2009 Nov 4;29(44):13746-50. doi: 10.1523/JNEUROSCI.3687-09.2009. | |
| 23405082 | Background | Rodriguez-Raecke R, Niemeier A, Ihle K, Ruether W, May A. Structural brain changes in chronic pain reflect probably neither damage nor atrophy. PLoS One. 2013;8(2):e54475. doi: 10.1371/journal.pone.0054475. Epub 2013 Feb 6. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| cognitive performance | Diagnostic Test | 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. |
|
| 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 |
| Universitätsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
|
| D012216 |
| Rheumatic Diseases |
| D001519 | Behavior |