ClubfootNCT00475631
Economic Evaluation of Clubfoot Treatment: One Centre's Experience
An observational study of Clubfoot, run by University of British Columbia.
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.
- First posted21 May 2007 (estimated)
- Study startOct 2003
Why it stopped: The person who started the study joined medical school
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ClubfootStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Alvarez, University of British Columbia
- Investigators
- Christine Alvarez, MD, Principal investigator, University of British Columbia
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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of Clubfoot Treatment: One Centre's Experience
- ClinicalTrials.gov ID
- NCT00475631
- Acronym / sponsor ID
- H03-70532
- Conditions
- Clubfoot
- Keywords
- Clubfoot, Chart review
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The person who started the study joined medical school
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Oct 2003
- First posted
- 21 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 day to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Diagnosed with clubfoot
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Alvarez, MD principal investigator
University of British Columbia
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.