NCT00294424

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?

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
833

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

February 22, 2006

Status Verified

January 1, 2006

First QC Date

February 21, 2006

Last Update Submit

February 21, 2006

Conditions

Osteoarthritis, HipOsteoarthritis, Knee

Keywords

Waiting timeTotal hip replacementTotal knee replacementQuality of lifeThe15DHarris Hip ScoreKnee ScorePain measurementCost-effectivenessMedicationHealth servicesSocial servicesRandomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (20)

  • 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

  • +15 more secondary outcomes

Interventions

Short waiting timePROCEDURE
Non-fixed waiting timePROCEDURE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with rheumatoid arthritis
  • Subjects with fractures
  • Subjects with haemophilia
  • Subjects with congenital deformities
  • Subjects with a need for re-arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stakes/National Research and Development Centre for Welfare and Health

Helsinki, Helsinki, 00531, Finland

Location

Related Publications (1)

  • 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)

    BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, HipOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Marja L Blom, PhD

    Academy Of Finland/ Stakes/ National Research and Development Centre for Welfare and Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2006

First Posted

February 22, 2006

Study Start

September 1, 2002

Study Completion

April 1, 2006

Last Updated

February 22, 2006

Record last verified: 2006-01

Locations

FI(1)