Change of Cognitive Performance Through Hip Replacement
NCT ID: NCT02997891
Last Updated: 2017-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
260 participants
OBSERVATIONAL
2016-02-29
2018-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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).
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.
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).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* planning for hip replacement surgery in Bad Bramstedt
Exclusion Criteria
* 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)
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Stiftung Endoprothetik
UNKNOWN
Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andreas Niemeier, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Hamburg-Eppendorf
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Klinikum Bad Bramstedt
Bad Bramstedt, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Andreas Niemeier, Prof. Dr.
Role: primary
Sönke Arlt, PD Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UKE 0545/110
Identifier Type: -
Identifier Source: org_study_id