Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements
NCT ID: NCT00294424
Last Updated: 2006-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
833 participants
INTERVENTIONAL
2002-09-30
2006-04-30
Brief Summary
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Detailed Description
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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).
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:
1. 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;
2. 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.
3. 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:
1. when placed on the waiting list by the orthopaedic surgeon (baseline),
2. at hospital admission,
3. three, and
4. 12 months after surgery.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Interventions
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Short waiting time
Non-fixed waiting time
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Subjects with fractures
* Subjects with haemophilia
* Subjects with congenital deformities
* Subjects with a need for re-arthroplasty
16 Years
ALL
No
Sponsors
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Hospital District of Helsinki and Uusimaa
OTHER
Coxa, Hospital for Joint Replacement
OTHER
Tampere University
OTHER
Orton Invalid Foundation
OTHER
Academy of Finland
OTHER
Principal Investigators
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Marja L Blom, PhD
Role: STUDY_DIRECTOR
Academy Of Finland/ Stakes/ National Research and Development Centre for Welfare and Health
Locations
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Stakes/National Research and Development Centre for Welfare and Health
Helsinki, Helsinki, Finland
Countries
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References
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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)
Other Identifiers
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AF51871
Identifier Type: -
Identifier Source: org_study_id