Osteoarthritis, HipKogniTEPNCT02997891
Change of Cognitive Performance Through Hip Replacement
An observational study of Osteoarthritis, Hip, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- everyday activity and cognitive performance
- How many people
- 260 participants
- Where
- 2 sitesGermany
- Study dates
- Feb 2016to May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- primary, unilateral coxarthrosis
- planning for hip replacement surgery in Bad Bramstedt
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Bad Bramstedt
Bad Bramstedt, 24576
Andreas Niemeier, Prof. Dr., +49(0) 4192 902415, niemeier@uke.de
- Recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Sönke Arlt, PD Dr., +49(0) 40 7410 53437, arlt@uke.de
About this study
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]
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.
Read the 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.
- Conditions
- Osteoarthritis, Hip
- Being tested
- everyday activity, cognitive performance
- Keywords
- cognition, hip replacement, physical activity, quality of life, psychological distress
- Medical subject headings
- Osteoarthritis, Hip, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
everyday activityDiagnostic 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).
cognitive performanceDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: everyday activity; Diagnostic Test: cognitive performance | |
| 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. Receives: Diagnostic Test: everyday activity; Diagnostic Test: cognitive performance |
What is being measured
The primary outcome is the main question the study is designed to answer.
attention and concentration performance (assessed by d2 Test of Attention)
Measured: Change from Baseline attention and concentration performance at 6 months
conceptual tracking, planning and flexibility (assessed by Trail Making Tests (Parts A and B)
Measured: Change from Baseline conceptual tracking, planning and flexibility at 6 months
semantic memory (assessed by FAS-Test [Verbal Fluency])
Measured: Change from Baseline semantic memory at 6 months
verbal episodic memory (Rivermead Behavioural Memory Test (RBMT) - story recall subtest) subtest
Measured: Change from Baseline verbal episodic memory at 6 months
visuospatial constructional ability and visual memory (assessed by Rey-Osterrieth Complex Figure Test)
Measured: Change from Baseline visuospatial constructional ability and visual memory at 6 months
Secondary outcomes (5)
subjective physical activity (assessed by Physical Activity Scale for the Elderly (PASE))
Measured: Change from Baseline subjective physical activity at 6 months
objective physical activity (assessed by pedometer GARAMIN vivofit)
Measured: Change from Baseline objective physical activity at 6 months
anxiety (assessed by the Generalized Anxiety Disorder 7-Scale (GAD-7))
Measured: Change from Baseline anxiety at 6 months
depression (assessed by the Patient Health Questionnaire (PHQ-9))
Measured: Change from Baseline depression at 6 months
quality of life (assessed by the SF-12 health survey)
Measured: Change from Baseline quality of life at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftung Endoprothetik
- Responsible party
- Sponsor
- Investigators
- Andreas Niemeier, Prof. Dr., Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997891
- Sponsor's protocol ID
- UKE 0545/110
- Acronym
- KogniTEP
- Status last verified
- Oct 2017
- First submitted
- 14 Jul 2016
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 19889986Rodriguez-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.
PubMed 23405082
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT02997891
- Acronym / sponsor ID
- KogniTEP / UKE 0545/110
- Conditions
- Osteoarthritis, Hip
- Keywords
- cognition, hip replacement, physical activity, quality of life, psychological distress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Stiftung Endoprothetik
- Study start
- Feb 2016
- Primary completion
- Apr 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Diagnostic Test: everyday activity, Diagnostic Test: cognitive performancePatients with primary, unilateral hip osteoarthritis in inpatient orthopedic acute treatment, who have a medical indication of a necessary artificial hip replacement implantation. |
| control group | – | Diagnostic Test: everyday activity, Diagnostic Test: cognitive performanceVolunteers 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- primary, unilateral coxarthrosis
- planning for hip replacement surgery in Bad Bramstedt
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| everyday activityTo 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 | control group, intervention group |
| cognitive performanceStandardized 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. | Diagnostic test | control group, intervention group |
Primary outcome
attention and concentration performance (assessed by d2 Test of Attention)
Time frame: Change from Baseline attention and concentration performance at 6 months
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
semantic memory (assessed by FAS-Test [Verbal Fluency])
Time frame: Change from Baseline semantic memory at 6 months
verbal episodic memory (Rivermead Behavioural Memory Test (RBMT) - story recall subtest) subtest
Time frame: Change from Baseline verbal episodic memory at 6 months
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
5 secondary outcomes
subjective physical activity (assessed by Physical Activity Scale for the Elderly (PASE))
Time frame: Change from Baseline subjective physical activity at 6 months
objective physical activity (assessed by pedometer GARAMIN vivofit)
Time frame: Change from Baseline objective physical activity at 6 months
anxiety (assessed by the Generalized Anxiety Disorder 7-Scale (GAD-7))
Time frame: Change from Baseline anxiety at 6 months
depression (assessed by the Patient Health Questionnaire (PHQ-9))
Time frame: Change from Baseline depression at 6 months
quality of life (assessed by the SF-12 health survey)
Time frame: Change from Baseline quality of life at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Background: PubMed 19889986Rodriguez-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.
- Background: PubMed 23405082Rodriguez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Niemeier, Prof. Dr. principal investigator
Universitätsklinikum Hamburg-Eppendorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Hip, run by Universitätsklinikum Hamburg-Eppendorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Niemeier, Prof. Dr. (+49(0)40 7410 54745, niemeier@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
attention and concentration performance (assessed by d2 Test of Attention) (time frame: Change from Baseline attention and concentration performance at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02997891, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2017.