Change of Cognitive Performance Through Hip Replacement

Osteoarthritis, Hip Clinical Trial

— KogniTEP  

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]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02997891
• Other study ID #: UKE 0545/110
• Status: Recruiting
• Phase: N/A
• First received: July 14, 2016
• Last updated: October 17, 2017
• Start date: February 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2017
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: Andreas Niemeier, Prof. Dr.
• Phone: +49(0)40 7410 54745
• Email: niemeier[@]uke.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

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).
• 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.

Locations

Country	Name	City	State
Germany	Klinikum Bad Bramstedt	Bad Bramstedt
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg

Sponsors (2)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf	Stiftung Endoprothetik

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	attention and concentration performance (assessed by d2 Test of Attention)		Change from Baseline attention and concentration performance at 6 months
Primary	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
Primary	semantic memory (assessed by FAS-Test [Verbal Fluency])		Change from Baseline semantic memory at 6 months
Primary	verbal episodic memory (Rivermead Behavioural Memory Test (RBMT) - story recall subtest) subtest		Change from Baseline verbal episodic memory at 6 months
Primary	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	subjective physical activity (assessed by Physical Activity Scale for the Elderly (PASE))		Change from Baseline subjective physical activity at 6 months
Secondary	objective physical activity (assessed by pedometer GARAMIN vivofit)		Change from Baseline objective physical activity at 6 months
Secondary	anxiety (assessed by the Generalized Anxiety Disorder 7-Scale (GAD-7))		Change from Baseline anxiety at 6 months
Secondary	depression (assessed by the Patient Health Questionnaire (PHQ-9))		Change from Baseline depression at 6 months
Secondary	quality of life (assessed by the SF-12 health survey)		Change from Baseline quality of life at 6 months

External Links

•   German studyflyer