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

August 9, 2015 updated by: Esa Jamsen, Coxa, Hospital for Joint 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

193

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33580
        • Coxa, Hospital for Joint Replacement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

tertiary care clinic

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 days (average)

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of surgical-site infections
Time Frame: 1 year
1 year
Prevalence of glucose metabolism disorders and metabolic syndrome
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coxa, Hospital for Joint Replacement

Collaborators

Tampere University

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (Estimate)

November 30, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 9, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HyTe-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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