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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
  Purpose

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.


Condition
Knee Replacement
Hip Replacement
Hyperglycemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Perioperative Hyperglycaemia in Primary Hip and Knee Replacement

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Coxa, Hospital for Joint Replacement:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

plasma sample (one per patient, collected before surgery)


Enrollment: 193
Study Start Date: December 2009
Study Completion Date: September 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hip and knee replacements recipients
Osteoarthritis patients undergoing elective primary hip and knee replacement and being followed-up in this study.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

tertiary care clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01021826

Locations
Finland
Coxa, Hospital for Joint Replacement
Tampere, Finland, 33580
Sponsors and Collaborators
Coxa, Hospital for Joint Replacement
University of Tampere
Investigators
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
  More Information

No publications provided

Responsible Party: Esa Jamsen, MD, PhD, Researcher, Coxa, Hospital for Joint Replacement
ClinicalTrials.gov Identifier: NCT01021826     History of Changes
Other Study ID Numbers: HyTe-1
Study First Received: November 27, 2009
Last Updated: February 13, 2013
Health Authority: Finland: Ethics Committee

Keywords provided by Coxa, Hospital for Joint Replacement:
knee replacement
hip replacement
hyperglycemia
diabetes
osteoarthritis

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013