ThrombosisNCT00159185
Epidemiology Study in Major Orthopaedic Surgery
An observational study of Thrombosis and Postoperative Complications, run by Hoersholm Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to: Create a database including a description of the patient population that undergoes total hip replacement with special emphasis on orthopedic and cardiovascular complications and the quality of life 1 year postoperatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis, Postoperative Complications, Quality of Life
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2004to May 2006
- 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
Who may be able to join
- All patients operated with Hip Arthroplasty Replacement in Hillerød and Hørsholm Hospitals from 1.1 2004.
Who cannot join
- Written informed consent denied
- Patients under 18 years of age.
- Patients not habitants of Denmark at the time of the operation.
- Patients without a CPR-number (civil registration number).
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to:
- Create a database including a description of the patient population that undergoes total hip replacement with special emphasis on orthopedic and cardiovascular complications and the quality of life 1 year postoperatively.
- Characterise the patient at risk for the above mentioned events
- Create methods for predicting patients at risk for short-term (90 days) and long term (1 year) complications in relation to hip replacement surgery.
Read the detailed description
Introduction:
Total hip replacement surgery is a standard procedure, which has been shown to be both cost-effective and to give the patient a pain free daily living. Since Sir Charnley made total hip replacement a standard procedure millions of hips have been implanted.
In Denmark about 100 out of 100.000 did get a hip replacement operation in 2001(DHAR).
When a patient with a painful hip due to arthrosis, arthritis, fracture sequelae and other reasons, is offered a total hip replacement, several issues are taken into consideration: concurrent diseases, bone quality, age, life expectancy, prosthesis type, operation methods etc.
In the elderly patient a thorough medical evaluation is performed in order to minimise the intraoperative risc for cardiopulmonary morbidity. Nearly all patients in Denmark (over 99%) are getting thromboprophylaxis during the hospital stay to minimise cardiovascular complications.
After surgery the patients visits the outpatient clinic for routine control after 3 and 12 months. After that time the patient is usually out of orthopedic control.
Evaluations of the procedures in Scandinavian countries are collected in databases. These databases are constructed by national collection of data sheets from each hospital performing the procedures. The collected data most often only include data as far as the arthroplasty is concerned. Normally there is no monitoring of the quality of the collected data - a considerable margin of errors in the results produced from these databases must there for be expected.
The amount of publications concerning total joint replacement is enormous, but most publications in this field come from clinical trials dealing with new pharmacological products or new implants.
Very few authors have considered the overall patient morbidity and quality of life after the hip replacement operation.
Therefore this Ph.D. project is planned to get more and newer data of the population that is offered a total hip replacement. Furthermore, it will be attempted to find prognostic factors as far as the overall risk for cardiopulmonary complications in the first 1 - 3 years after the operation.
Purpose:
The purpose of this study is to:
Create a database including a description of the patient population that undergo total hip replacement with special emphasis on orthopedic and cardiovascular complications and the quality of life 1 year postoperatively.
Characterise the patient at risk for the above mentioned events
Create methods for predicting patients at risk for short-term (90 days) and long term (1 years) complications in relation to hip replacement surgery.
Hypothesis:
It is a well defined small group of high risk patients that gets the serious cardiovascular complications.
The risk for cardiovascular complications is increased for a longer period than the postoperative hospital stay.
A not neglectable group of the patients do not get the expected benefit from the operation.
Methods:
A prospective monocentre, longitudinal cohort study of 500 patients operated in the County of Frederiksborg from 01.01 2004.
The data will be collected by interview before the operation, on day 5 and after 3 month and a year.
And additional data will be collected from patient files, local hip- and anaesthesia databases, laboratory system, the Danish Hospital Discharge Register (LPR), autopsy reports and death register.
Statistical methods:
In the PhD study is included various courses, including a course on statistical methods. External statistical aid might be necessary.
Patients:
Inclusion criteria:
All patients to be operated with total hip replacement in Frederiksborg amt from 01.01.2004 until 500 pt. have been included.
Exclusion criteria:
Refuse of consent and age under 18years.
Ethical Considerations:
Local Scientific Ethical Committee and theDanish Dataprotection Agency has to approve the project.
The project follows the Guidelines for Good Clinical Practise.
The investigation will not imply any discomfort and no risk for the patient.
- Conditions
- Thrombosis, Postoperative Complications, Quality of Life
- Keywords
- Arthroplasty, Replacement, Hip, Epidemiology
- Medical subject headings
- Thrombosis, Postoperative Complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJan 2004
- Study completionMay 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Defined population
- Time perspective
- Prospective
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Hoersholm Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Camilla Ryge, MD, Study chair, Hoersholm Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00159185
- Sponsor's protocol ID
- ESMOS
- Status last verified
- Sep 2005
- First submitted
- 9 Sep 2005
- Last updated
- 21 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology Study in Major Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT00159185
- Acronym / sponsor ID
- ESMOS
- Conditions
- Thrombosis, Postoperative Complications, Quality of Life
- Keywords
- Arthroplasty, Replacement, Hip, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Hoersholm HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jan 2004
- Study completion
- May 2006
- First posted
- 12 Sep 2005 (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:
- Create a database including a description of the patient population that undergoes total hip replacement with special emphasis on orthopedic and cardiovascular complications and the quality of life 1 year postoperatively.
- Characterise the patient at risk for the above mentioned events
- Create methods for predicting patients at risk for short-term (90 days) and long term (1 year) complications in relation to hip replacement surgery.
Detailed description
Introduction:
Total hip replacement surgery is a standard procedure, which has been shown to be both cost-effective and to give the patient a pain free daily living. Since Sir Charnley made total hip replacement a standard procedure millions of hips have been implanted.
In Denmark about 100 out of 100.000 did get a hip replacement operation in 2001(DHAR).
When a patient with a painful hip due to arthrosis, arthritis, fracture sequelae and other reasons, is offered a total hip replacement, several issues are taken into consideration: concurrent diseases, bone quality, age, life expectancy, prosthesis type, operation methods etc.
In the elderly patient a thorough medical evaluation is performed in order to minimise the intraoperative risc for cardiopulmonary morbidity. Nearly all patients in Denmark (over 99%) are getting thromboprophylaxis during the hospital stay to minimise cardiovascular complications.
After surgery the patients visits the outpatient clinic for routine control after 3 and 12 months. After that time the patient is usually out of orthopedic control.
Evaluations of the procedures in Scandinavian countries are collected in databases. These databases are constructed by national collection of data sheets from each hospital performing the procedures. The collected data most often only include data as far as the arthroplasty is concerned. Normally there is no monitoring of the quality of the collected data - a considerable margin of errors in the results produced from these databases must there for be expected.
The amount of publications concerning total joint replacement is enormous, but most publications in this field come from clinical trials dealing with new pharmacological products or new implants.
Very few authors have considered the overall patient morbidity and quality of life after the hip replacement operation.
Therefore this Ph.D. project is planned to get more and newer data of the population that is offered a total hip replacement. Furthermore, it will be attempted to find prognostic factors as far as the overall risk for cardiopulmonary complications in the first 1 - 3 years after the operation.
Purpose:
The purpose of this study is to:
Create a database including a description of the patient population that undergo total hip replacement with special emphasis on orthopedic and cardiovascular complications and the quality of life 1 year postoperatively.
Characterise the patient at risk for the above mentioned events
Create methods for predicting patients at risk for short-term (90 days) and long term (1 years) complications in relation to hip replacement surgery.
Hypothesis:
It is a well defined small group of high risk patients that gets the serious cardiovascular complications.
The risk for cardiovascular complications is increased for a longer period than the postoperative hospital stay.
A not neglectable group of the patients do not get the expected benefit from the operation.
Methods:
A prospective monocentre, longitudinal cohort study of 500 patients operated in the County of Frederiksborg from 01.01 2004.
The data will be collected by interview before the operation, on day 5 and after 3 month and a year.
And additional data will be collected from patient files, local hip- and anaesthesia databases, laboratory system, the Danish Hospital Discharge Register (LPR), autopsy reports and death register.
Statistical methods:
In the PhD study is included various courses, including a course on statistical methods. External statistical aid might be necessary.
Patients:
Inclusion criteria:
All patients to be operated with total hip replacement in Frederiksborg amt from 01.01.2004 until 500 pt. have been included.
Exclusion criteria:
Refuse of consent and age under 18years.
Ethical Considerations:
Local Scientific Ethical Committee and theDanish Dataprotection Agency has to approve the project.
The project follows the Guidelines for Good Clinical Practise.
The investigation will not imply any discomfort and no risk for the patient.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients operated with Hip Arthroplasty Replacement in Hillerød and Hørsholm Hospitals from 1.1 2004.
Key exclusion criteria (4 listed)
- Written informed consent denied
- Patients under 18 years of age.
- Patients not habitants of Denmark at the time of the operation.
- Patients without a CPR-number (civil registration number).
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
Not reported in the source record.
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 21 Jul 2006.
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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.
Camilla Ryge, MD study chair
Hoersholm 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 Thrombosis and Postoperative Complications, run by Hoersholm Hospital at 1 site in Denmark.
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 1 inclusion and 4 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 21 Jul 2006. 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 Denmark. 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.
Where can I read the original study information?
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 21 Jul 2006.