Knee ReplacementHyTe-1NCT01021826
Perioperative Hyperglycaemia in Primary Total Hip and Knee Replacement
An observational study of Knee Replacement and Hip Replacement, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Replacement, Hip Replacement, Hyperglycemia
- How many people
- 193 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2009to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary care clinic
Who may be able to join
- Diagnosis of osteoarthritis
- Scheduled for primary hip or knee replacement
Who cannot join
- Arthritis other than osteoarthritis
- Medication affecting glucose metabolism (excl. antidiabetic agents)
- Not undergoing hip or knee replacement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Perioperative Hyperglycaemia in Primary Hip and Knee Replacement
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.
- Conditions
- Knee Replacement, Hip Replacement, Hyperglycemia
- Keywords
- knee replacement, hip replacement, hyperglycemia, diabetes, osteoarthritis
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hip and knee replacements recipients | Osteoarthritis patients undergoing elective primary hip and knee replacement and being followed-up in this study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days (average)
Secondary outcomes (2)
Incidence of surgical-site infections
Measured: 1 year
Prevalence of glucose metabolism disorders and metabolic syndrome
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJul 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coxa, Hospital for Joint Replacement
- Sponsor type
- University, hospital or other
- Collaborators
- Tampere University
- Responsible party
- Principal investigator, Esa Jamsen, Coxa, Hospital for Joint Replacement
- Investigators
- Teemu Moilanen, MD, PhD, Study director, Coxa, Hospital for Joint ReplacementEsa Jämsen, MD, PhD, Principal investigator, Coxa, Hospital for Joint ReplacementPasi Nevalainen, MD, PhD, Principal investigator, Tampere University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021826
- Sponsor's protocol ID
- HyTe-1
- Acronym
- HyTe-1
- Status last verified
- Aug 2015
- First submitted
- 27 Nov 2009
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Perioperative Hyperglycaemia in Primary Hip and Knee Replacement
- ClinicalTrials.gov ID
- NCT01021826
- Acronym / sponsor ID
- HyTe-1 / HyTe-1
- Conditions
- Knee Replacement, Hip Replacement, Hyperglycemia
- Keywords
- knee replacement, hip replacement, hyperglycemia, diabetes, osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Coxa, Hospital for Joint ReplacementUniversity, hospital or other
- Collaborators
- Tampere University
- Study start
- Dec 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hip and knee replacements recipients | – | –Osteoarthritis patients undergoing elective primary hip and knee replacement and being followed-up in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care clinic
Key inclusion criteria (2 listed)
- Diagnosis of osteoarthritis
- Scheduled for primary hip or knee replacement
Key exclusion criteria (3 listed)
- Arthritis other than osteoarthritis
- Medication affecting glucose metabolism (excl. antidiabetic agents)
- Not undergoing hip or knee replacement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Occurrence (and severity) of hyperglycemia following primary hip or knee replacement
Time frame: 3 days (average)
Follow-up covers postoperative hospital stay at the operating hospital, that lasts typically 2-5 days.
2 secondary outcomes
Incidence of surgical-site infections
Time frame: 1 year
Prevalence of glucose metabolism disorders and metabolic syndrome
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2015.
- Results publication: PubMed 25409255Jamsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Replacement and Hip Replacement, run by Coxa, Hospital for Joint Replacement at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence (and severity) of hyperglycemia following primary hip or knee replacement (time frame: 3 days (average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01021826, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.