Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery
1 other identifier
observational
34
1 country
2
Brief Summary
The primary hypothesis that orthopaedic surgery induces a neuroinflammatory response within 48 hours after elective hip or knee surgery and that there is an association between exaggerated CNS inflammatory response or impaired inflammatory resolution and postoperative cognitive dysfunction within one week and at three months postoperatively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2014
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2018
CompletedApril 16, 2019
April 1, 2019
1.6 years
November 10, 2014
April 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Neuroinflammation measured as IL-6 in CSF
IL-6 in CSF
Up to 48 hours postoperatively
Secondary Outcomes (5)
Cognitive function
Before surgery, within 7 days after surgery and 3 month after surgery
Peripheral inflammatory response
Up to 48 hours
Neuroinflammation
Up to 48 hours
Neuroinflammation
Up to 48 hours postoperatively
Neuroinflammation
Up to 48 hours postoperatively
Eligibility Criteria
34 elective orthopedic patients undergoing hip or knee arthroplasty
You may qualify if:
- ASA Physical Health Class 1-4
- Age 50-85 years
- Fluent in Swedish language
- Scheduled for primary hip replacement surgery due to arthrosis
- MMSE (minimental state test score \>= 25.
You may not qualify if:
- Patient refusal to participate in the trial
- Current autoimmune disease, including arthritis
- Ongoing smoking, snuff or other nicotine compound treatment
- Significant neurologic or psychiatric disorder (such as Alzheimer's disease, Parkinson's disease, Multiple sclerosis, schizophrenia, depression, diagnosis of dementia or cognitive impairment as defined by a preoperative MMSE score ≤ 24
- History of stroke with neurological sequelae.
- Current severe cardiac (NYHA\>IV) or renal (plasma creatinine\> 0.250 mmol/l) Coagulopathy making spinal anesthesia and intrathecal catheter placement impossible
- Terminal phase of a chronic disease.
- Patient on chronic steroidal therapy
- Poorly controlled diabetes mellitus.
- Presumed uncooperativeness or legal incapacity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Sahlgrenska University Hospitalcollaborator
Study Sites (2)
Sahlgrenska University Hospital
Gothenburg, Sweden
Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna
Stockholm, SE-17176, Sweden
Biospecimen
CSF and blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 10, 2014
First Posted
May 3, 2016
Study Start
September 1, 2014
Primary Completion
March 30, 2016
Study Completion
December 31, 2018
Last Updated
April 16, 2019
Record last verified: 2019-04