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Change of Cognitive Performance Through Hip Replacement (KogniTEP)

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ClinicalTrials.gov Identifier: NCT02997891
Recruitment Status : Unknown
Verified October 2017 by Universitätsklinikum Hamburg-Eppendorf.
Recruitment status was:  Recruiting
First Posted : December 20, 2016
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Stiftung Endoprothetik
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
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.

Condition or disease Intervention/treatment
Osteoarthritis, Hip Diagnostic Test: everyday activity Diagnostic Test: cognitive performance

Detailed Description:

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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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Change of Cognitive Performance for Older People Through Artificial Hip Replacement Implantation [German Title: Veränderungen Der Kognitiven Leistungsfähigkeit älterer Menschen Durch Hüft-TEP Implantation]
Study Start Date : February 2016
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Diagnostic Test: everyday activity
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).

Diagnostic Test: cognitive performance
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.

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.
Diagnostic Test: everyday activity
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).

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

Secondary Outcome Measures :
  1. subjective physical activity (assessed by Physical Activity Scale for the Elderly (PASE)) [ Time Frame: Change from Baseline subjective physical activity at 6 months ]
  2. objective physical activity (assessed by pedometer GARAMIN vivofit) [ Time Frame: Change from Baseline objective physical activity at 6 months ]
  3. anxiety (assessed by the Generalized Anxiety Disorder 7-Scale (GAD-7)) [ Time Frame: Change from Baseline anxiety at 6 months ]
  4. depression (assessed by the Patient Health Questionnaire (PHQ-9)) [ Time Frame: Change from Baseline depression at 6 months ]
  5. quality of life (assessed by the SF-12 health survey) [ Time Frame: Change from Baseline quality of life at 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02997891


Contacts
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Contact: Andreas Niemeier, Prof. Dr. +49(0)40 7410 54745 niemeier@uke.de
Contact: Sönke Arlt, PD Dr. +49 (0)40 7410 53437 arlt@uke.de

Locations
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Germany
Klinikum Bad Bramstedt Recruiting
Bad Bramstedt, Germany, 24576
Contact: Andreas Niemeier, Prof. Dr.    +49(0) 4192 902415    niemeier@uke.de   
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Sönke Arlt, PD Dr.    +49(0) 40 7410 53437    arlt@uke.de   
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Stiftung Endoprothetik
Investigators
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Principal Investigator: Andreas Niemeier, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf

Publications:
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT02997891     History of Changes
Other Study ID Numbers: UKE 0545/110
First Posted: December 20, 2016    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
cognition
hip replacement
physical activity
quality of life
psychological distress
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases