Change of Cognitive Performance Through Hip Replacement

NCT02997891 | Unknown

• 1 other identifier: UKE 0545/110
• Study Type: observational
• Target: 260
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis, Hip

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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) subtest

  Change from Baseline verbal episodic memory at 6 months

• 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 Outcomes (5)

• 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

Study Arms (2)

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; 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.

Diagnostic Test: everyday activity; Diagnostic Test: cognitive performance

Interventions

everyday activity DIAGNOSTIC_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).

control group; intervention group

cognitive performance DIAGNOSTIC_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.

control group; intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• primary, unilateral coxarthrosis
• planning for hip replacement surgery in Bad Bramstedt

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Stiftung Endoprothetik: collaborator

Study Sites (2)

Klinikum Bad Bramstedt

Bad Bramstedt, 24576, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Related 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.

  PMID: 19889986 BACKGROUND

• 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.

  PMID: 23405082 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Hip; Motor Activity

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Study Officials

• Andreas Niemeier, Prof. Dr.

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas Niemeier, Prof. Dr.

CONTACT

+49(0)40 7410 54745; niemeier@uke.de

Sönke Arlt, PD Dr.

CONTACT

+49 (0)40 7410 53437; arlt@uke.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: December 20, 2016
• Study Start: February 1, 2016
• Primary Completion: April 1, 2018
• Study Completion: May 1, 2018
• Last Updated: October 18, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)