ClubfootNCT01067651
Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method
A study testing Plaster of Paris (POP) casting using the Ponseti Method and Semi-Rigid Fiberglass softcast using the Ponseti Method in people with Clubfoot and Ponseti Method, run by Alberta Children's Hospital at 1 site in Canada.
Trial summary
The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method. Read more about this study
- Who is it for?
- Ages 1 week to 12 weeks
- Conditions the study is for
- Clubfoot, Ponseti Method, Talipes Equinovarus
- What is being tested?
- Plaster of Paris (POP) casting using the Ponseti Method and Semi-Rigid Fiberglass softcast using the Ponseti Method
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 week to 12 weeks
- All sexes
- Child
Who may be able to join
- congenital idiopathic clubfoot
Who cannot join
- positional equinovarus
- teratologic etiologies of clubfoot
- treatment started at another center
- refuse randomization
- do not understand English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial
The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.
Read the detailed description
Congenital idiopathic clubfoot is the most common congenital deformity in children. It can be a major cause of disability for children, as well as an emotional stress for parents. The Ponseti method of clubfoot correction, consisting of serial manipulations and casting, is now the gold standard of treatment. It has traditionally been described using plaster of Paris (POP) above-knee casts; however, recently semi-rigid fiberglass softcast (SRF, 3M Scotchcast) has grown in popularity. There are currently no randomized controlled trials to prove its efficacy with respect to POP.
- Conditions
- Clubfoot, Ponseti Method, Talipes Equinovarus, Casting
- Being tested
- Plaster of Paris (POP) casting using the Ponseti Method, Semi-Rigid Fiberglass softcast using the Ponseti Method
- Medical subject headings
- Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaster of Paris (POP) casting using the Ponseti MethodDevice
Semi-Rigid Fiberglass softcast using the Ponseti MethodDevice
| Study group | Role | What they receive |
|---|---|---|
| Plaster of Paris (POP) | Active comparator | Not described Receives: Device: Plaster of Paris (POP) casting using the Ponseti Method |
| semi-rigid fiberglass softcast (SRF, 3M Scotchcast) | Active comparator | Not described Receives: Device: Semi-Rigid Fiberglass softcast using the Ponseti Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of casts required to correct the clubfoot deformities
Measured: time required for the foot to be ready for a percutaneous tendo-achilles tenotomy (if necessary), or when dorsiflexion of the ankle greater than or equal to 15 degrees (Pirani=0) was achieved
Secondary outcomes (6)
need for percutaneous tendo-achilles tenotomy
total time in casts (weeks)
ease of cast removal
time of cast removal
Measured: number of minutes required for each cast removal
method(s) of cast removal
other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for ClubfootStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Children's Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Jason Howard, MD, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067651
- Sponsor's protocol ID
- E-20062
- Status last verified
- Apr 2007
- First submitted
- 10 Feb 2010
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.
PubMed 10934626Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
PubMed 11304107Berman AT, Parks BG. A comparison of the mechanical properties of fiberglass cast materials and their clinical relevance. J Orthop Trauma. 1990;4(1):85-92. doi: 10.1097/00005131-199003000-00015.
PubMed 2313436Carroll NC. Clubfoot: what have we learned in the last quarter century? J Pediatr Orthop. 1997 Jan-Feb;17(1):1-2. No abstract available.
PubMed 8989690Colburn M, Williams M. Evaluation of the treatment of idiopathic clubfoot by using the Ponseti method. J Foot Ankle Surg. 2003 Sep-Oct;42(5):259-67. doi: 10.1016/s1067-2516(03)00312-0.
PubMed 14566717Cooper DM, Dietz FR. Treatment of idiopathic clubfoot. A thirty-year follow-up note. J Bone Joint Surg Am. 1995 Oct;77(10):1477-89. doi: 10.2106/00004623-199510000-00002.
PubMed 7593056Coss HS, Hennrikus WL. Parent satisfaction comparing two bandage materials used during serial casting in infants. Foot Ankle Int. 1996 Aug;17(8):483-6. doi: 10.1177/107110079601700809.
PubMed 8863028Dobbs MB, Corley CL, Morcuende JA, Ponseti IV. Late recurrence of clubfoot deformity: a 45-year followup. Clin Orthop Relat Res. 2003 Jun;(411):188-92. doi: 10.1097/01.blo.0000065837.77325.19.
PubMed 12782875Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86(1):22-7. doi: 10.2106/00004623-200401000-00005.
PubMed 14711941Flynn JM, Donohoe M, Mackenzie WG. An independent assessment of two clubfoot-classification systems. J Pediatr Orthop. 1998 May-Jun;18(3):323-7.
PubMed 9600557Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007 Mar;89(3):487-93. doi: 10.2106/JBJS.F.00169.
PubMed 17332096Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. J Pediatr Orthop. 2002 Jul-Aug;22(4):517-21.
PubMed 12131451Ippolito E, Farsetti P, Caterini R, Tudisco C. Long-term comparative results in patients with congenital clubfoot treated with two different protocols. J Bone Joint Surg Am. 2003 Jul;85(7):1286-94. doi: 10.2106/00004623-200307000-00015.
PubMed 12851354Ippolito E, Fraracci L, Farsetti P, Di Mario M, Caterini R. The influence of treatment on the pathology of club foot. CT study at maturity. J Bone Joint Surg Br. 2004 May;86(4):574-80.
PubMed 15174556Laaveg SJ, Ponseti IV. Long-term results of treatment of congenital club foot. J Bone Joint Surg Am. 1980 Jan;62(1):23-31.
PubMed 7351412
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01067651
- Acronym / sponsor ID
- E-20062
- Conditions
- Clubfoot, Ponseti Method, Talipes Equinovarus, Casting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Alberta Children's HospitalUniversity, hospital or other
- First posted
- 11 Feb 2010 (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.
The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.
Detailed description
Congenital idiopathic clubfoot is the most common congenital deformity in children. It can be a major cause of disability for children, as well as an emotional stress for parents. The Ponseti method of clubfoot correction, consisting of serial manipulations and casting, is now the gold standard of treatment. It has traditionally been described using plaster of Paris (POP) above-knee casts; however, recently semi-rigid fiberglass softcast (SRF, 3M Scotchcast) has grown in popularity. There are currently no randomized controlled trials to prove its efficacy with respect to POP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Plaster of Paris (POP) | Active comparator | Device: Plaster of Paris (POP) casting using the Ponseti Method |
| semi-rigid fiberglass softcast (SRF, 3M Scotchcast) | Active comparator | Device: Semi-Rigid Fiberglass softcast using the Ponseti Method |
Who may qualify
- Ages
- 1 week to 12 weeks
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- congenital idiopathic clubfoot
Key exclusion criteria (5 listed)
- positional equinovarus
- teratologic etiologies of clubfoot
- treatment started at another center
- refuse randomization
- do not understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plaster of Paris (POP) casting using the Ponseti Method | Device | Plaster of Paris (POP) |
| Semi-Rigid Fiberglass softcast using the Ponseti Method | Device | semi-rigid fiberglass softcast (SRF, 3M Scotchcast) |
Primary outcome
number of casts required to correct the clubfoot deformities
Time frame: time required for the foot to be ready for a percutaneous tendo-achilles tenotomy (if necessary), or when dorsiflexion of the ankle greater than or equal to 15 degrees (Pirani=0) was achieved
6 secondary outcomes
need for percutaneous tendo-achilles tenotomy
total time in casts (weeks)
ease of cast removal
time of cast removal
Time frame: number of minutes required for each cast removal
method(s) of cast removal
other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2010.
- Background: PubMed 10934626Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.
- Background: PubMed 11304107Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gotzsche PC, Lang T; CONSORT GROUP (Consolidated Standards of Reporting Trials). The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med. 2001 Apr 17;134(8):663-94. doi: 10.7326/0003-4819-134-8-200104170-00012.
- Background: PubMed 2313436Berman AT, Parks BG. A comparison of the mechanical properties of fiberglass cast materials and their clinical relevance. J Orthop Trauma. 1990;4(1):85-92. doi: 10.1097/00005131-199003000-00015.
- Background: PubMed 8989690Carroll NC. Clubfoot: what have we learned in the last quarter century? J Pediatr Orthop. 1997 Jan-Feb;17(1):1-2. No abstract available.
- Background: PubMed 14566717Colburn M, Williams M. Evaluation of the treatment of idiopathic clubfoot by using the Ponseti method. J Foot Ankle Surg. 2003 Sep-Oct;42(5):259-67. doi: 10.1016/s1067-2516(03)00312-0.
- Background: PubMed 7593056Cooper DM, Dietz FR. Treatment of idiopathic clubfoot. A thirty-year follow-up note. J Bone Joint Surg Am. 1995 Oct;77(10):1477-89. doi: 10.2106/00004623-199510000-00002.
- Background: PubMed 8863028Coss HS, Hennrikus WL. Parent satisfaction comparing two bandage materials used during serial casting in infants. Foot Ankle Int. 1996 Aug;17(8):483-6. doi: 10.1177/107110079601700809.
- Background: PubMed 12782875Dobbs MB, Corley CL, Morcuende JA, Ponseti IV. Late recurrence of clubfoot deformity: a 45-year followup. Clin Orthop Relat Res. 2003 Jun;(411):188-92. doi: 10.1097/01.blo.0000065837.77325.19.
- Background: PubMed 14711941Dobbs MB, Rudzki JR, Purcell DB, Walton T, Porter KR, Gurnett CA. Factors predictive of outcome after use of the Ponseti method for the treatment of idiopathic clubfeet. J Bone Joint Surg Am. 2004 Jan;86(1):22-7. doi: 10.2106/00004623-200401000-00005.
- Background: PubMed 9600557Flynn JM, Donohoe M, Mackenzie WG. An independent assessment of two clubfoot-classification systems. J Pediatr Orthop. 1998 May-Jun;18(3):323-7.
- Background: PubMed 17332096Haft GF, Walker CG, Crawford HA. Early clubfoot recurrence after use of the Ponseti method in a New Zealand population. J Bone Joint Surg Am. 2007 Mar;89(3):487-93. doi: 10.2106/JBJS.F.00169.
- Background: PubMed 12131451Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. J Pediatr Orthop. 2002 Jul-Aug;22(4):517-21.
- Website provides links to the publication entitled: Clubfoot: Ponseti ManagementLink provided by the sponsor.
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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.
Jason Howard, MD principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaster of Paris (POP) casting using the Ponseti Method and Semi-Rigid Fiberglass softcast using the Ponseti Method in people with Clubfoot and Ponseti Method, run by Alberta Children's Hospital at 1 site in Canada.
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 5 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: finished, as of the sponsor's last update on 11 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
number of casts required to correct the clubfoot deformities (time frame: time required for the foot to be ready for a percutaneous tendo-achilles tenotomy (if necessary), or when dorsiflexion of the ankle greater than or equal to 15 degrees (Pirani=0) was achieved). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067651, which also lists 31 linked publications.
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 11 Feb 2010.