Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement

Hyperglycemia Clinical Trial

— HyTe-1  

Official title:

Determinants of Perioperative Hyperglycaemia in Primary Hip and Knee Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01021826
• Other study ID #: HyTe-1
• Status: Completed
• Phase: N/A
• First received: November 27, 2009
• Last updated: August 9, 2015
• Start date: December 2009
• Est. completion date: September 2012

Study information

• Verified date: August 2015
• Source: Coxa, Hospital for Joint Replacement
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: September 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hip Replacement
• Hyperglycemia
• Knee Replacement

Locations

Country	Name	City	State
Finland	Coxa, Hospital for Joint Replacement	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Coxa, Hospital for Joint Replacement	University of Tampere

Country where clinical trial is conducted

Finland, 

References & Publications (1)

Jämsen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Incidence of surgical-site infections		1 year	No
Secondary	Prevalence of glucose metabolism disorders and metabolic syndrome		Baseline	No