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Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02759965
Enrollment
34
Registered
2016-05-03
Start date
2014-09-01
Completion date
2018-12-31
Last updated
2019-04-16

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

Conditions

Acute Phase Reaction, Surgery

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.

Detailed description

Patients at 50-85 years of age undergoing orthopedic surgery will be investigated in the perioperative period to detect signs of neuroinflammation using serial CSF and blood sampling for 48 hours in combination with cognitive testing preoperatively, at 3-7 days and after 3 months.

Interventions

None listed

Sponsors

Sahlgrenska University Hospital
CollaboratorOTHER
Karolinska University Hospital
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
50 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Neuroinflammation measured as IL-6 in CSFUp to 48 hours postoperativelyIL-6 in CSF

Secondary

MeasureTime frameDescription
Peripheral inflammatory responseUp to 48 hoursCytokines i peripheral blood
NeuroinflammationUp to 48 hoursCNS specific markers in blood
Cognitive functionBefore surgery, within 7 days after surgery and 3 month after surgeryA cognitive test battery will be applied

Countries

Sweden

Outcome results

None listed

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