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

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ClinicalTrials.gov Identifier: NCT01021826
Recruitment Status : Completed
First Posted : November 30, 2009
Last Update Posted : August 11, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Knee Replacement Hip Replacement Hyperglycemia

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.

Study Design

Study Type : Observational
Actual Enrollment : 193 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determinants of Perioperative Hyperglycaemia in Primary Hip and Knee Replacement
Study Start Date : December 2009
Primary Completion Date : July 2011
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Hip and knee replacements recipients
Osteoarthritis patients undergoing elective primary hip and knee replacement and being followed-up in this study.


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of surgical-site infections [ Time Frame: 1 year ]
  2. Prevalence of glucose metabolism disorders and metabolic syndrome [ Time Frame: Baseline ]

Biospecimen Retention:   Samples Without DNA
plasma sample (one per patient, collected before surgery)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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
First Posted: November 30, 2009    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases