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Completed

NCT Number: NCT01021826

Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement

The purpose of this study is to analyze how common stress hyperglycaemia (abnormally high blood glucose) is in primary hip and knee replacement surgeries and which factors predispose to hyperglycaemia.

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Key information

Conditions

Knee Replacement Arthritis Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hip Replacement Hyperglycemia Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Coxa, Hospital for Joint Replacement

Tampere, 33580, Finland

About this study

Postoperative infections remain one of the most frequent reasons of failure of hip and knee prostheses. Diabetes increases the risk of infections. In other fields of surgery, hyperglycemia induced by surgical stress (stress/perioperative hyperglycemia) has been associated with higher rates of postoperative infections and complications. Such studies have not yet been performed in the field of joint replacement surgery. Unlike several other risk factors of infected joint replacements, hyperglycemia is potentially modifiable and therefore its prevalence, predisposing factors and association with postoperative infections are of interest.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of osteoarthritis
  • Scheduled for primary hip or knee replacement

Exclusion criteria

  • Arthritis other than osteoarthritis
  • Medication affecting glucose metabolism (excl. antidiabetic agents)
  • Not undergoing hip or knee replacement

Treatment and study plan

Primary outcomes

  1. Occurrence (and severity) of hyperglycemia following primary hip or knee replacement

    Time frame: 3 days (average)

    Follow-up covers postoperative hospital stay at the operating hospital, that lasts typically 2-5 days.

Secondary outcomes

  1. Incidence of surgical-site infections

    Time frame: 1 year

  2. Prevalence of glucose metabolism disorders and metabolic syndrome

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Coxa, Hospital for Joint Replacement

Other

Collaborators

  • Tampere University

Registry information

Official study title

Determinants of Perioperative Hyperglycaemia in Primary Hip and Knee Replacement

Acronym: HyTe-1

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Nov 30, 2009
Registry last updated
Aug 11, 2015

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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