Clinical Trials Directory

Trials / Unknown

UnknownNCT00294424

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

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.

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
833 (planned)
Sponsor
Academy of Finland · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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 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: 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

Interventions

TypeNameDescription
PROCEDUREShort waiting time
PROCEDURENon-fixed waiting time

Timeline

Start date
2002-09-01
Completion
2006-04-01
First posted
2006-02-22
Last updated
2006-02-22

Locations

1 site across 1 country: Finland

Source: ClinicalTrials.gov record NCT00294424. Inclusion in this directory is not an endorsement.