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Change of Cognitive Performance Through Hip Replacement

Change of Cognitive Performance for Older People Through Artificial Hip Replacement Implantation [German Title: Veränderungen Der Kognitiven Leistungsfähigkeit älterer Menschen Durch Hüft-TEP Implantation]

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02997891
Acronym
KogniTEP
Enrollment
260
Registered
2016-12-20
Start date
2016-02-29
Completion date
2018-05-31
Last updated
2017-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip

Keywords

cognition, hip replacement, physical activity, quality of life, psychological distress

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.

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.

Interventions

DIAGNOSTIC_TESTeveryday 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_TESTcognitive 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.

Sponsors

Stiftung Endoprothetik
CollaboratorUNKNOWN
Universitätsklinikum Hamburg-Eppendorf
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
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
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) subtestChange from Baseline verbal episodic memory at 6 months

Secondary

MeasureTime 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
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

Countries

Germany

Contacts

Primary ContactAndreas Niemeier, Prof. Dr.
niemeier@uke.de+49(0)40 7410 54745
Backup ContactSönke Arlt, PD Dr.
arlt@uke.de+49 (0)40 7410 53437

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026