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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Academy of Finland.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
HUS,HUCH Jorvi Hospital,
Coxa, Hospital for Joint Replacement
University of Tampere
HUS,HUCH Surgical Hospital
Orton Invalid Foundation
Information provided by:
Academy of Finland
ClinicalTrials.gov Identifier:
NCT00294424
First received: February 21, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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?


Condition Intervention
Osteoarthritis, Hip
Osteoarthritis, Knee
Procedure: Short waiting time
Procedure: Non-fixed waiting time

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
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.

Resource links provided by NLM:


Further study details as provided by Academy of Finland:

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

Estimated Enrollment: 833
Study Start Date: September 2002
Estimated Study Completion Date: April 2006
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.
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294424

Locations
Finland
Stakes/National Research and Development Centre for Welfare and Health
Helsinki, Finland, 00531
Sponsors and Collaborators
Academy of Finland
HUS,HUCH Jorvi Hospital,
Coxa, Hospital for Joint Replacement
University of Tampere
HUS,HUCH Surgical Hospital
Orton Invalid Foundation
Investigators
Study Director: Marja L Blom, PhD Academy Of Finland/ Stakes/ National Research and Development Centre for Welfare and Health
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00294424     History of Changes
Other Study ID Numbers: AF51871
Study First Received: February 21, 2006
Last Updated: February 21, 2006
Health Authority: Finland: The National Advisory Board on Health Care Ethics (ETENE)

Keywords provided by Academy of Finland:
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

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014