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

Primary Purpose

Osteoarthritis, Hip, Osteoarthritis, Knee

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Short waiting time
Non-fixed waiting time
Sponsored by
Academy of Finland
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis, Hip focused on measuring 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

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stakes/National Research and Development Centre for Welfare and Health

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
February 21, 2006
Last Updated
February 21, 2006
Sponsor
Academy of Finland
Collaborators
Hospital District of Helsinki and Uusimaa, Coxa, Hospital for Joint Replacement, Tampere University, Orton Invalid Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00294424
Brief Title
Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Academy of Finland
Collaborators
Hospital District of Helsinki and Uusimaa, Coxa, Hospital for Joint Replacement, Tampere University, Orton Invalid Foundation

4. Oversight

5. Study Description

Brief 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip, Osteoarthritis, Knee
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
833 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Short waiting time
Intervention Type
Procedure
Intervention Name(s)
Non-fixed waiting time
Primary Outcome Measure Information:
Title
The generic, 15-dimensional and standardised health status instrument 15D
Title
when placed on the waiting list, at admission, 3 months and 12 months after surgery
Secondary Outcome Measure Information:
Title
Modified Harris Hip Score
Title
Modified Knee Score
Title
10-cm horizontal visual analog scale (VAS)
Title
Perceived health on a scale 1-5: excellent, very good, good, moderate and poor
Title
Use and costs of health services
Title
Use and costs of social services
Title
Use and costs of informal care
Title
Use and costs of medication
Title
Patients' demographic characteristics like:
Title
-age
Title
-gender
Title
-education
Title
-marital status
Title
-employment status
Title
-BMI (body mass index)
Title
-co-morbidity
Title
-housing
Title
-home municipality
Title
when placed on the waiting list, at admission, 3 months and 12 months after surgery
Title
Hospital costs during hospital treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marja L Blom, PhD
Organizational Affiliation
Academy Of Finland/ Stakes/ National Research and Development Centre for Welfare and Health
Official's Role
Study Director
Facility Information:
Facility Name
Stakes/National Research and Development Centre for Welfare and Health
City
Helsinki
ZIP/Postal Code
00531
Country
Finland

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
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Study on Costs and Effects of Waiting Time in Total Hip and Knee Replacements

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