Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement

NCT ID: NCT01021826

Last Updated: 2015-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

193 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Replacement Hip Replacement Hyperglycemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hip and knee replacements recipients

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tampere University

OTHER

Sponsor Role collaborator

Coxa, Hospital for Joint Replacement

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Esa Jamsen

MD, PhD, Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Teemu Moilanen, MD, PhD

Role: STUDY_DIRECTOR

Coxa, Hospital for Joint Replacement

Esa Jämsen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Coxa, Hospital for Joint Replacement

Pasi Nevalainen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Coxa, Hospital for Joint Replacement

Tampere, , Finland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Finland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 25409255 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HyTe-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.