Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Osteoarthritis, Hip, Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Short waiting time
* Procedure: Non-fixed waiting time


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Subjects with rheumatoid arthritis Subjects with fractures Subjects with haemophilia Subjects with congenital deformities Subjects with a need for re-arthroplasty

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Short waiting time|nan|
|Procedure: Non-fixed waiting time|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The15D, Waiting time, Total hip replacement, Total knee replacement, Quality of life, Harris Hip Score, Knee Score, Pain measurement, Cost-effectiveness, Medication, Health services, Social services, Randomized Controlled Trial