Overview

This trial is active, not recruiting.

Conditions osteoarthritis, hip, osteoarthritis, knee
Treatments short waiting time, non-fixed waiting time
Sponsor Academy of Finland
Collaborator HUS,HUCH Jorvi Hospital,
Start date September 2002
End date April 2006
Trial size 833 participants
Trial identifier NCT00294424, AF51871

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?

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind
Primary purpose diagnostic

Primary Outcomes

Measure
The generic, 15-dimensional and standardised health status instrument 15D
time frame:
when placed on the waiting list, at admission, 3 months and 12 months after surgery
time frame:

Secondary Outcomes

Measure
Modified Harris Hip Score
time frame:
Modified Knee Score
time frame:
10-cm horizontal visual analog scale (VAS)
time frame:
Perceived health on a scale 1-5: excellent, very good, good, moderate and poor
time frame:
Use and costs of health services
time frame:
Use and costs of social services
time frame:
Use and costs of informal care
time frame:
Use and costs of medication
time frame:
Patients' demographic characteristics like:
time frame:
-age
time frame:
-gender
time frame:
-education
time frame:
-marital status
time frame:
-employment status
time frame:
-BMI (body mass index)
time frame:
-co-morbidity
time frame:
-housing
time frame:
-home municipality
time frame:
when placed on the waiting list, at admission, 3 months and 12 months after surgery
time frame:
Hospital costs during hospital treatment
time frame:

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2006.
Information provided to ClinicalTrials.gov by Academy of Finland.