Osteoarthritis, HipNCT00294424
Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements
A study testing Short waiting time and Non-fixed waiting time in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Academy of Finland at 1 site in Finland.
Trial summary
The aim of this study is to compare the cost-effectiveness of major joint replacement in patients with short and non-fixed (control group) waiting time (WT). After being placed on the waiting list, patients will be randomized into two groups through regular contact with the practice staff: (1) Patients with non-fixed… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Osteoarthritis, Hip, Osteoarthritis, Knee
- What is being tested?
- Short waiting time and Non-fixed waiting time
- Type of treatment
- Surgery or procedure
- How many people
- 833 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2002to Apr 2006
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a need for a primary unilateral or bilateral THR (total hip replacement) or TKR (total knee replacement) due to osteoarthritis (OA) evaluated by the orthopaedic surgeon
- aged 16 years or older
- female or male
- patient is placed on the waiting list in a research hospital
- the patent is willing and mentally able to participate in the study.
Who cannot join
- Subjects with rheumatoid arthritis
- Subjects with fractures
- Subjects with haemophilia
- Subjects with congenital deformities
- Subjects with a need for re-arthroplasty
Trial locations and contacts
1 site in 1 country.
Finland1 site
Stakes/National Research and Development Centre for Welfare and Health
Helsinki, Helsinki, 00531
About this study
Official title: A Prospective, Multi-Centre Study on Costs and Effects of Waiting Time in Patients Undergoing Total Hip and Knee Replacement Surgery. A Randomized Controlled Trial.
The aim of this study is to compare the cost-effectiveness of major joint replacement in patients with short and non-fixed (control group) waiting time (WT). After being placed on the waiting list, patients will be randomized into two groups through regular contact with the practice staff: (1) Patients with non-fixed waiting time (patient undergoes hospital's normal procedure from the date (s)he is added to the waiting list to the date of operation), and (2) patients with short waiting time (operated in maximum three months). The main question is: is it possible to improve the cost-effectiveness of major joint replacement by shortening waiting time?
Read the detailed description
The aim of this study is to compare the cost-effectiveness of major joint replacement in patients with short and non-fixed (control group) waiting time (WT). After being placed on the waiting list, patients will be randomized into two groups through regular contact with the practice staff:
- Patients with non-fixed waiting time (patient undergoes hospital's normal procedure from the date (s)he is added to the waiting list to the date of operation), and
- patients with short waiting time (operated in maximum three months).
For ethical reasons, care will be taken to avoid any risk of inequality between the patient groups. Such inequality might result if some patients should wait for access to treatment longer than normally or if short waiting times would accounted for more than half of the hospital's surgical capacity, for instance. The number of patients placed on the waiting list varies from one month to another, being specific to each hospital. Therefore no advance estimate can be made of the number of patients to be placed on the list. Consequently, the following arrangements will be made:
- the patients randomised into the short WT group could only be operated on every fourth month, and only half of the hospital's one-month surgical capacity could be allocated as short WTs, so the number of short WTs will be restricted and determined specifically for each hospital;
- it will be ensured that all eligible patients placed on the waiting list have a chance of getting recruited into the study (including the possibility of short WT) by not restricting the size of the non-fixed WT group. In order to avoid selection bias among the patients, the groups will be different in size.
- Recruitments will be made in periods of three months in order to avoid the waiting time for the short WT group exceeding three months.
Randomization is made by the nurse responsible using consecutively numbered and sealed envelopes. Participants complete a self-administered questionnaire at four specific points in time:
- when placed on the waiting list by the orthopaedic surgeon (baseline),
- at hospital admission,
- three, and
- 12 months after surgery.
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee
- Being tested
- Short waiting time, Non-fixed waiting time
- Keywords
- Waiting time, Total hip replacement, Total knee replacement, Quality of life, The15D, Harris Hip Score, Knee Score, Pain measurement, Cost-effectiveness, Medication, Health services, Social services, Randomized Controlled Trial
- Medical subject headings
- Osteoarthritis, Hip, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short waiting timeProcedure or surgery
Non-fixed waiting timeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The generic, 15-dimensional and standardised health status instrument 15D
when placed on the waiting list, at admission, 3 months and 12 months after surgery
Secondary outcomes (20)
Modified Harris Hip Score
Modified Knee Score
10-cm horizontal visual analog scale (VAS)
Perceived health on a scale 1-5: excellent, very good, good, moderate and poor
Use and costs of health services
Use and costs of social services
Use and costs of informal care
Use and costs of medication
Patients' demographic characteristics like:
-age
-gender
-education
-marital status
-employment status
-BMI (body mass index)
-co-morbidity
-housing
-home municipality
when placed on the waiting list, at admission, 3 months and 12 months after surgery
Hospital costs during hospital treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startSep 2002
- Study completionApr 2006
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 Osteoarthritis, HipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 833 participants
Sponsor and investigators
- Lead sponsor
- Academy of Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital District of Helsinki and Uusimaa, Coxa, Hospital for Joint Replacement, Tampere University, Orton Invalid Foundation
- Investigators
- Marja L Blom, PhD, Study director, Academy Of Finland/ Stakes/ National Research and Development Centre for Welfare and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294424
- Sponsor's protocol ID
- AF51871
- Status last verified
- Jan 2006
- First submitted
- 21 Feb 2006
- Last updated
- 22 Feb 2006
- Results posted
- No
Publications
Sintonen H. 2001. The 15D instrument of health-related quality of life: properties and applications. The Finnish Medical Society Duodecim, Ann Med 33: 328-336 Sintonen H. http://www.15d-instrument.net/15d Drummond M. 2001. Introducing economic and quality of life measurements into clinical studies. Ann Med 33: 344-353 Mahomed NN, Arndt DC, McGrory BJ, Harris WH. The Harris Hip Score. Comparison of patient self-report with surgeon assessment. J Arthroplasty 2001; 16: 575-580 Insall JN, Lawrence DD, Scott RD, Scott WN. 1989. Rationale of The Knee Society Clinical Rating System. Clin Orthop. 248: 13-14 McDowell I, Newell C. 1996. Measuring Health: A Guide to Rating Scales and Questionnaires, 2nd edn. New York: Oxford University Press Hujanen T. Unit cost of health care in Finland 2001. Helsinki: Stakes. Aiheita 1/2003 (in Finnish) Pharmaca Fennica. CD-Pharmaca. 2004. Lääketietokeskus (in Finnish)
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Centre Study on Costs and Effects of Waiting Time in Patients Undergoing Total Hip and Knee Replacement Surgery. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT00294424
- Acronym / sponsor ID
- AF51871
- Conditions
- Osteoarthritis, Hip, Osteoarthritis, Knee
- Keywords
- Waiting time, Total hip replacement, Total knee replacement, Quality of life, The15D, Harris Hip Score, Knee Score, Pain measurement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 833 participants
- Lead sponsor
- Academy of FinlandUniversity, hospital or other
- Collaborators
- Hospital District of Helsinki and Uusimaa, Coxa, Hospital for Joint Replacement, Tampere University, Orton Invalid Foundation
- Study start
- Sep 2002
- Study completion
- Apr 2006
- First posted
- 22 Feb 2006 (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 aim of this study is to compare the cost-effectiveness of major joint replacement in patients with short and non-fixed (control group) waiting time (WT). After being placed on the waiting list, patients will be randomized into two groups through regular contact with the practice staff: (1) Patients with non-fixed waiting time (patient undergoes hospital's normal procedure from the date (s)he is added to the waiting list to the date of operation), and (2) patients with short waiting time (operated in maximum three months). The main question is: is it possible to improve the cost-effectiveness of major joint replacement by shortening waiting time?
Detailed description
The aim of this study is to compare the cost-effectiveness of major joint replacement in patients with short and non-fixed (control group) waiting time (WT). After being placed on the waiting list, patients will be randomized into two groups through regular contact with the practice staff:
- Patients with non-fixed waiting time (patient undergoes hospital's normal procedure from the date (s)he is added to the waiting list to the date of operation), and
- patients with short waiting time (operated in maximum three months).
For ethical reasons, care will be taken to avoid any risk of inequality between the patient groups. Such inequality might result if some patients should wait for access to treatment longer than normally or if short waiting times would accounted for more than half of the hospital's surgical capacity, for instance. The number of patients placed on the waiting list varies from one month to another, being specific to each hospital. Therefore no advance estimate can be made of the number of patients to be placed on the list. Consequently, the following arrangements will be made:
- the patients randomised into the short WT group could only be operated on every fourth month, and only half of the hospital's one-month surgical capacity could be allocated as short WTs, so the number of short WTs will be restricted and determined specifically for each hospital;
- it will be ensured that all eligible patients placed on the waiting list have a chance of getting recruited into the study (including the possibility of short WT) by not restricting the size of the non-fixed WT group. In order to avoid selection bias among the patients, the groups will be different in size.
- Recruitments will be made in periods of three months in order to avoid the waiting time for the short WT group exceeding three months.
Randomization is made by the nurse responsible using consecutively numbered and sealed envelopes. Participants complete a self-administered questionnaire at four specific points in time:
- when placed on the waiting list by the orthopaedic surgeon (baseline),
- at hospital admission,
- three, and
- 12 months after surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- a need for a primary unilateral or bilateral THR (total hip replacement) or TKR (total knee replacement) due to osteoarthritis (OA) evaluated by the orthopaedic surgeon
- aged 16 years or older
- female or male
- patient is placed on the waiting list in a research hospital
- the patent is willing and mentally able to participate in the study.
Key exclusion criteria (5 listed)
- Subjects with rheumatoid arthritis
- Subjects with fractures
- Subjects with haemophilia
- Subjects with congenital deformities
- Subjects with a need for re-arthroplasty
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short waiting time | Procedure or surgery | – |
| Non-fixed waiting time | Procedure or surgery | – |
Primary outcome
The generic, 15-dimensional and standardised health status instrument 15D
when placed on the waiting list, at admission, 3 months and 12 months after surgery
20 secondary outcomes
Modified Harris Hip Score
Modified Knee Score
10-cm horizontal visual analog scale (VAS)
Perceived health on a scale 1-5: excellent, very good, good, moderate and poor
Use and costs of health services
Use and costs of social services
Use and costs of informal care
Use and costs of medication
Patients' demographic characteristics like:
-age
-gender
-education
-marital status
-employment status
-BMI (body mass index)
-co-morbidity
-housing
-home municipality
when placed on the waiting list, at admission, 3 months and 12 months after surgery
Hospital costs during hospital treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2006.
- BackgroundSintonen H. 2001. The 15D instrument of health-related quality of life: properties and applications. The Finnish Medical Society Duodecim, Ann Med 33: 328-336 Sintonen H. http://www.15d-instrument.net/15d Drummond M. 2001. Introducing economic and quality of life measurements into clinical studies. Ann Med 33: 344-353 Mahomed NN, Arndt DC, McGrory BJ, Harris WH. The Harris Hip Score. Comparison of patient self-report with surgeon assessment. J Arthroplasty 2001; 16: 575-580 Insall JN, Lawrence DD, Scott RD, Scott WN. 1989. Rationale of The Knee Society Clinical Rating System. Clin Orthop. 248: 13-14 McDowell I, Newell C. 1996. Measuring Health: A Guide to Rating Scales and Questionnaires, 2nd edn. New York: Oxford University Press Hujanen T. Unit cost of health care in Finland 2001. Helsinki: Stakes. Aiheita 1/2003 (in Finnish) Pharmaca Fennica. CD-Pharmaca. 2004. Lääketietokeskus (in Finnish)
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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.
Marja L Blom, PhD study director
Academy Of Finland/ Stakes/ National Research and Development Centre for Welfare and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short waiting time and Non-fixed waiting time in people with Osteoarthritis, Hip and Osteoarthritis, Knee, run by Academy of Finland 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Feb 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 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?
Results are not available in the source record.
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?
The generic, 15-dimensional and standardised health status instrument 15D. The study lists 2 primary outcomes in all. 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 NCT00294424, 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 22 Feb 2006.