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ClubfootNCT00475631

Economic Evaluation of Clubfoot Treatment: One Centre's Experience

An observational study of Clubfoot, run by University of British Columbia.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Purpose: The purpose of the study is to complete a cost analysis of the different methods used for clubfoot treatment. Objectives: Short-term objective: To explore the experience of British Columbia Children's Hospital (BCCH) with costs and outcomes related to the various forms of clubfoot management since 1984 to… Read more about this study

Who is it for?
Ages 1 day to 14 years
Conditions the study is for
Clubfoot
How many people
0 participants
Where
No sites listed yet
Study dates
Oct 2003to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: All patients who were diagnosed and treated for idiopathic clubfoot at BCCH between January 1984 and present are eligible for the study. Patients whose clubfoot is a secondary diagnosis to another disorder (mal-position, neuromuscular disorder and chromosomal abnormality) are excluded from this study.

Who may be able to join

  • Diagnosed with clubfoot

Who cannot join

None listed.

About this study

Purpose:

The purpose of the study is to complete a cost analysis of the different methods used for clubfoot treatment.

Objectives:

Short-term objective: To explore the experience of British Columbia Children's Hospital (BCCH) with costs and outcomes related to the various forms of clubfoot management since 1984 to present.

Long-term objective: To use the information gathered in this project and apply it to future studies in the clubfoot research program and to do a complete cost-benefit analysis.

Hypothesis: The hypothesis of the study is that the BCCH clubfoot treatment program has better outcomes in terms of reduced financial costs than the traditional surgical management.

Read the detailed description

Inclusion criteria:

All patients who were diagnosed and treated for idiopathic clubfoot at BCCH between January 1984 and present are eligible for the study. Patients whose clubfoot is a secondary diagnosis to another disorder (mal-position, neuromuscular disorder and chromosomal abnormality) are excluded from this study.

Database design:

Using information gathered from literature review and interviews with several of the orthopaedic surgeons at BCCH the most common treatment methods for clubfoot and the ones that are and have been in use in BCCH were identified. Six treatment methods were then described in detail. These treatment methods are: comprehensive release, posterio-medial release, posterior release, Kite-method, Ponseti-method and BCCH-method. From all different treatment-steps possible "units" were designed. The units that were designed are: initial consult, clinic visit, consult physiotherapist, consult occupational therapist, OT-splint, consult orthotist, X-ray, Boots and Bars, AFO by orthotist, custom orthotic, shoes, surgery, cast applied during surgery, surgery second foot, surgery extra, anaesthesia extra 1-3, daycare surgery, overnight stay in hospital, gastrosoleus defunctioning using Botox, Botox, gait analysis and non-clubfoot related hospital encounter. Per unit there are more treatment "options" available. For example in the unit "clinic visit", there are 18 options, such as clinic visit, clinic visit with manipulation and casting using plaster of paris below knee, clinic visit with manipulation and casting using plaster of paris above knee, clinic visit with manipulation and casting using 3-M soft cast below knee. Within the unit "X-ray" there are 3 options such as unilateral X-ray of the foot, bilateral X-ray of the foot, X-ray of the pelvis.

More units were designed that are not part of the treatment, but do have their impact on the costs concerning the treatment and therefore have to be considered. These units are: number of persons traveling, days away form home, lost wages, air transportation, ground transport, mileage, accommodation and meals.

All these units, together with patient demographics (patient ID, last name, first name, gender, hometown and distance to BCCH) and intervention type (one of the 6 treatment-regimes that the patient fits in) formed the database, which was set up in the Microsoft Excel program.

Patient Data collection:

All patients that are eligible for this study were identified using the hospital data retrieval system. The patient's hospital medical records will be collected and chart review will be performed. Patient data will be entered into the database, using one line for every visit (either as an inpatient or as an outpatient) to the hospital.

Costing Data collection:

Direct costs: A detailed breakdown of all "parts" constituting the units was performed. Costing information on all these parts was then obtained using a great variety of sources, including the MSP-billing book, personal communication with a pharmacy- representative and interviews with nursing representatives, an expert in the financial department and experts in the decision support department.

General overhead costs: The general overhead costs will be determined using information from the decision support services and from the Orthopaedic department.

Data analysis: It is a cost analysis between the different methods of orthopaedic treatment for clubfoot. Statistical analysis will be completed on all continuous variables. Statistical analysis will be completed using SAS Statistical Software (SAS Institute, Cary, NC).

Conditions
Clubfoot
Keywords
Clubfoot, Chart review
Medical subject headings
Clubfoot

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2007 (estimated)
  2. Study startOct 2003

Why it stopped: The person who started the study joined medical school

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Retrospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00475631
Sponsor's protocol ID
H03-70532
Status last verified
May 2017
First submitted
16 May 2007
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Clubfoot, run by University of British Columbia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.

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