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OpenTrials
Completed

NCT Number: NCT02759965

Neuroinflammation and Cognitive Dysfunction After Orthopedic Surgery

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.

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Key information

Age range

50 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Sahlgrenska University Hospital, Gothenburg, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Neuroinflammation measured as IL-6 in CSF

    Time frame: Up to 48 hours postoperatively

    IL-6 in CSF

Secondary outcomes

  1. Cognitive function

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

    A cognitive test battery will be applied

  2. Peripheral inflammatory response

    Time frame: Up to 48 hours

    Cytokines i peripheral blood

  3. Neuroinflammation

    Time frame: Up to 48 hours

    CNS specific markers in blood

  4. Neuroinflammation

    Time frame: Up to 48 hours postoperatively

    CNS specific markers in CSF

  5. Neuroinflammation

    Time frame: Up to 48 hours postoperatively

    INflammatory Inflammatory markers in CSF

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Sahlgrenska University Hospital

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2018
First posted
May 3, 2016
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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