NCT01021826

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

1.6 years

First QC Date

November 27, 2009

Last Update Submit

August 9, 2015

Conditions

Keywords

knee replacementhip replacementhyperglycemiadiabetesosteoarthritis

Outcome Measures

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.

    3 days (average)

Secondary Outcomes (2)

  • Incidence of surgical-site infections

    1 year

  • Prevalence of glucose metabolism disorders and metabolic syndrome

    Baseline

Study Arms (1)

Hip and knee replacements recipients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

tertiary care clinic

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Coxa, Hospital for Joint Replacement

Tampere, 33580, Finland

Location

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma sample (one per patient, collected before surgery)

MeSH Terms

Conditions

HyperglycemiaDiabetes MellitusOsteoarthritis

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Teemu Moilanen, MD, PhD

    Coxa, Hospital for Joint Replacement

    STUDY DIRECTOR
  • Esa Jämsen, MD, PhD

    Coxa, Hospital for Joint Replacement

    PRINCIPAL INVESTIGATOR
  • Pasi Nevalainen, MD, PhD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Researcher

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

December 1, 2009

Primary Completion

July 1, 2011

Study Completion

September 1, 2012

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations