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TerminatedNCT01743313HyTe-2Updated Oct 18, 2023

Glucose Metabolism Disorders and Metabolic Syndrome Before and After Primary Hip and Knee Replacement

An observational study in Hyperglycemia, Hypercholesterolemia and Persistent Postoperative Pain, sponsored by Coxa, Hospital for Joint Replacement. Terminated at 1 site in Finland. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-10-18.

Sponsored by Coxa, Hospital for Joint Replacement · Observational

Why this study was terminated
Primary researcher not able to continue research at the moment.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
155
Ages
18 Years to 120 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

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
2012
with 1 other
Observational
3 of 11
none open now
Registered
4th 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 2012, is one of 3 observational ones, and was the 4th 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 to 120 Years · all sexes · no healthy volunteers.

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02

Study summary

Osteoarthritis patients undergoing primary hip and knee replacement are followed-up and changes in their glucose metabolism and other metabolic parameters (obesity, cholesterol levels) are examined. Persistent postoperative pain is examined as secondary outcome.

Read the detailed description

Glucose metabolism disorders (diabetes and pre-diabetes) and metabolic syndrome are common in joint replacement recipients. Improved physical activity following joint replacement could lead to better glucose control in diabetes and ameliorate impaired glucose and cholesterol levels. In this study patients previously recruited to "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study are being followed-up for one year in order to analyze if joint replacements have an effect on these metabolic abnormalities. In addition, the effect of glucose metabolism disorders on occurrence of persistent pain after surgery is analyzed.

03

Conditions studied

  • Hyperglycemia
  • Hypercholesterolemia
  • Persistent Postoperative Pain
  • Hip Replacement
  • Knee Replacement

Keywords

  • glucose metabolism disorders
  • metabolic syndrome
  • joint replacement
  • osteoarthritis
04

Who can participate

Ages eligible
18 Years to 120 Years
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

  • Primary hip and knee replacement for osteoarthritis
  • Enrolled previously into study NCT01021826

Exclusion criteria

Exclusion Criteria:

  • Arthritis other than osteoarthritis (based on study NCT01021826)
  • Medication affecting glucose metabolism (excl. antidiabetic agents) (based on study NTC01021826)
  • Died before follow-up phase
  • Did not undergo the planned hip or knee replacement
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
155 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Hip and knee replacement recipients

    Hip and knee replacement recipients (with osteoarthritis) enrolled previously into "Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement" study (NCT01021826).

06

What researchers measure

Primary outcomes

  1. Change in glucose tolerance, measured using oral glucose tolerance test

    The patients are grouped into three groups that are evaluated 12, 18 and ca. 24 months after surgery.

    Time frame: Baseline and 12-24 months after surgery

Secondary outcomes

  1. Change in cholesterol levels (HDL, LDL, triglycerides)

    Time frame: Baseline and 12-24 months after surgery

  2. Prolonged postoperative pain

    Assessed using visual analog scale. Patients are divided in three groups that are evaluated 12, 18 and 24 months after surgery.

    Time frame: 12-24 months after surgery

Other outcomes

  1. Change in plasma adipokine and cytokine concentrations

    Time frame: Baseline and 12-24 months after surgery.

07

Study locations

1 site
  • Coxa, Hospital for Joint Replacement
    Tampere, 33520, Finland
08

References and documents

Publications

  • Rajamaki TJ, Jamsen E, Puolakka PA, Nevalainen PI, Moilanen T. Diabetes is associated with persistent pain after hip and knee replacement. Acta Orthop. 2015;86(5):586-93. doi: 10.3109/17453674.2015.1044389. PubMed 25953426 ↗
09

Timeline

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

The record gives a start of Apr 2012, a primary completion of Aug 2012 and a completion of Jun 2017. 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
Dec 2, 2012
First posted
Dec 6, 2012
Start
Apr 2012
Primary completionActual
Aug 2012
CompletionActual
Jun 2017
Last update
Oct 18, 2023
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 Oct 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01743313
Lead sponsor
Coxa, Hospital for Joint Replacement
Collaborators
Tampere University, Tampere University Hospital
Responsible party
Esa Jamsen (MD, PhD, Researcher, Coxa, Hospital for Joint Replacement) — Principal investigator
First posted
Dec 6, 2012
Start date
Apr 2012
Primary completion
Aug 2012
Completion
Jun 2017
Last update
Oct 18, 2023

Study contacts

Esa Jämsen, MD, PhD
study director · Coxa, Hospital for Joint Replacement

Oversight

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

Not currently enrolling

This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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