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Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement (HyTe-1)

This study has been completed.
Sponsor:
Collaborator:
University of Tampere
Information provided by (Responsible Party):
Esa Jamsen, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier:
NCT01021826
First received: November 27, 2009
Last updated: February 13, 2013
Last verified: February 2013
History of Changes

November 27, 2009
February 13, 2013
December 2009
July 2011   (final data collection date for primary outcome measure)
Occurrence (and severity) of hyperglycemia following primary hip or knee replacement [ Time Frame: 3 days (average) ] [ Designated as safety issue: No ]
Follow-up covers postoperative hospital stay at the operating hospital, that lasts typically 2-5 days.
Occurrence (and severity) of hyperglycemia following primary hip or knee replacement [ Time Frame: perioperative hospitalization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01021826 on ClinicalTrials.gov Archive Site
  • Incidence of surgical-site infections [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Prevalence of glucose metabolism disorders and metabolic syndrome [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Incidence of surgical-site infections [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement
Determinants of Perioperative Hyperglycaemia in Primary 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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma sample (one per patient, collected before surgery)
Non-Probability Sample

tertiary care clinic
  • Knee Replacement
  • Hip Replacement
  • Hyperglycemia
Not Provided
Hip and knee replacements recipients
Osteoarthritis patients undergoing elective primary hip and knee replacement and being followed-up in this study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
193
September 2012
July 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01021826
HyTe-1
No
Esa Jamsen, Coxa, Hospital for Joint Replacement
Coxa, Hospital for Joint Replacement
University of Tampere
Study Director: Teemu Moilanen, MD, PhD Coxa, Hospital for Joint Replacement
Principal Investigator: Esa Jämsen, MD, PhD Coxa, Hospital for Joint Replacement
Principal Investigator: Pasi Nevalainen, MD, PhD Tampere University Hospital
Coxa, Hospital for Joint Replacement
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP