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CompletedNCT01021826HyTe-1Updated Aug 11, 2015

Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement

An observational study in Knee Replacement, Hip Replacement and Hyperglycemia, sponsored by Coxa, Hospital for Joint Replacement. Completed at 1 site in Finland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-11.

Sponsored by Coxa, Hospital for Joint Replacement · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
193
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 11 studies in Hyperglycemia with a site in Finland — 1 open to participants now, 2 under way, none of them phase 3. Hyperglycemia · Finland.

Started
2009
with 1 other
Observational
3 of 11
none open now
Registered
2nd of 11
by date
Lead sponsor
2 of 11
Coxa, Hospital for Joint Replacement

Among the 11 studies in Hyperglycemia with a site in Finland, this one is one of 2 that started in 2009, is one of 3 observational ones, and was the 2nd registered.

Hyperglycemia

801 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.

Browse Hyperglycemia studies →

Open to participants now

1 of the 11 studies in Hyperglycemia with a site in Finland is open now. Recruiting first, the newest first:

A study can be open while its sites in Finland have not opened yet or have stopped. Only those recruiting at a site in Finland →

Who these studies take

Of the 71 Hyperglycemia studies recruiting now, 42 (59%) set no upper age limit and 23 (32%) stop at 75 or younger; 10 take children under 18; 15 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Knee Replacement
  • Hip Replacement
  • Hyperglycemia

Keywords

  • knee replacement
  • hip replacement
  • hyperglycemia
  • diabetes
  • osteoarthritis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

tertiary care clinic

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Arthritis other than osteoarthritis
  • Medication affecting glucose metabolism (excl. antidiabetic agents)
  • Not undergoing hip or knee replacement
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
193 participants (actual)
Biospecimen retention
Samples without dna

Groups and cohorts

  • Hip and knee replacements recipients

    Osteoarthritis patients undergoing elective primary hip and knee replacement and being followed-up in this study.

06

What researchers measure

Primary outcomes

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

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

    Time frame: 3 days (average)

Secondary outcomes

  1. Incidence of surgical-site infections

    Time frame: 1 year

  2. Prevalence of glucose metabolism disorders and metabolic syndrome

    Time frame: Baseline

07

Study locations

1 site
  • Coxa, Hospital for Joint Replacement
    Tampere, 33580, Finland
08

References and documents

Publications

  • Jamsen E, Nevalainen PI, Eskelinen A, Kalliovalkama J, Moilanen T. Risk factors for perioperative hyperglycemia in primary hip and knee replacements. Acta Orthop. 2015 Apr;86(2):175-82. doi: 10.3109/17453674.2014.987064. Epub 2014 Nov 18. PubMed 25409255 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2009, a primary completion of Jul 2011 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 27, 2009
First posted
Nov 30, 2009
Start
Dec 2009
Primary completionActual
Jul 2011
CompletionActual
Sep 2012
Last update
Aug 11, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01021826
Lead sponsor
Coxa, Hospital for Joint Replacement
Collaborators
Tampere University
Responsible party
Esa Jamsen (MD, PhD, Researcher, Coxa, Hospital for Joint Replacement) — Principal investigator
First posted
Nov 30, 2009
Start date
Dec 2009
Primary completion
Jul 2011
Completion
Sep 2012
Last update
Aug 11, 2015

Study contacts

Teemu Moilanen, MD, PhD
study director · Coxa, Hospital for Joint Replacement
Esa Jämsen, MD, PhD
principal investigator · Coxa, Hospital for Joint Replacement
Pasi Nevalainen, MD, PhD
principal investigator · Tampere University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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