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CompletedNCT02759965Updated Apr 16, 2019

Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

An observational study in Surgery and Acute Phase Reaction, sponsored by Karolinska University Hospital. Completed at 2 sites in Sweden. Open to male participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-04-16.

Sponsored by Karolinska University Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
34
Ages
50 Years to 85 Years
Sex
Male
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Study 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.

Read the 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.

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Conditions studied

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In context

Neuroinflammatory Diseases

150 studies on the registry are indexed under Neuroinflammatory Diseases; 70 are open to participants now.

This study's enrollment of 34 is below the median of 100 across 52 observational studies indexed under Neuroinflammatory Diseases.

Browse Neuroinflammatory Diseases studies →

Lead sponsor

Karolinska University Hospital is the lead sponsor of 275 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

34 elective orthopedic patients undergoing hip or knee arthroplasty

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

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.
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. Neuroinflammation measured as IL-6 in CSF

    IL-6 in CSF

    Time frame: Up to 48 hours postoperatively

Secondary outcomes

  1. Cognitive function

    A cognitive test battery will be applied

    Time frame: Before surgery, within 7 days after surgery and 3 month after surgery

  2. Peripheral inflammatory response

    Cytokines i peripheral blood

    Time frame: Up to 48 hours

  3. Neuroinflammation

    CNS specific markers in blood

    Time frame: Up to 48 hours

  4. Neuroinflammation

    CNS specific markers in CSF

    Time frame: Up to 48 hours postoperatively

  5. Neuroinflammation

    INflammatory Inflammatory markers in CSF

    Time frame: Up to 48 hours postoperatively

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Study locations

2 sites
  • Sahlgrenska University Hospital
    Gothenburg, Sweden
  • Department of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital, Solna
    Stockholm, SE-17176, Sweden
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02759965
Lead sponsor
Karolinska University Hospital
Collaborators
Sahlgrenska University Hospital
Responsible party
Lars I Eriksson (Professor, Karolinska University Hospital) — Principal investigator
First posted
May 3, 2016
Start date
Sep 1, 2014
Primary completion
Mar 30, 2016
Completion
Dec 31, 2018
Last update
Apr 16, 2019

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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