Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method
Study Details
Study Description
Brief Summary
The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Plaster of Paris (POP)
|
Device: Plaster of Paris (POP) casting using the Ponseti Method
|
Active Comparator: semi-rigid fiberglass softcast (SRF, 3M Scotchcast)
|
Device: Semi-Rigid Fiberglass softcast using the Ponseti Method
|
Outcome Measures
Primary Outcome Measures
- number of casts required to correct the clubfoot deformities [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 Outcome Measures
- need for percutaneous tendo-achilles tenotomy []
- total time in casts (weeks) []
- ease of cast removal []
- time of cast removal [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. []
Eligibility Criteria
Criteria
Inclusion Criteria:
- congenital idiopathic clubfoot
Exclusion Criteria:
-
positional equinovarus
-
teratologic etiologies of clubfoot
-
treatment started at another center
-
refuse randomization
-
do not understand English
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alberta Children's Hospital | Calgary | Alberta | Canada | T3B 6A8 |
Sponsors and Collaborators
- Alberta Children's Hospital
Investigators
- Principal Investigator: Jason Howard, MD, IWK Health Centre
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Altman DG, Schulz KF, Moher D, Egger M, Davidoff F, Elbourne D, Gøtzsche 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. Review.
- Berman 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.
- Carroll NC. Clubfoot: what have we learned in the last quarter century? J Pediatr Orthop. 1997 Jan-Feb;17(1):1-2.
- Colburn 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.
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- Ippolito 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.
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- Morcuende JA, Dolan LA, Dietz FR, Ponseti IV. Radical reduction in the rate of extensive corrective surgery for clubfoot using the Ponseti method. Pediatrics. 2004 Feb;113(2):376-80.
- Noonan KJ, Richards BS. Nonsurgical management of idiopathic clubfoot. J Am Acad Orthop Surg. 2003 Nov-Dec;11(6):392-402. Review.
- Pirani S, Zeznik L, Hodges D. Magnetic resonance imaging study of the congenital clubfoot treated with the Ponseti method. J Pediatr Orthop. 2001 Nov-Dec;21(6):719-26.
- Pittner DE, Klingele KE, Beebe AC. Treatment of clubfoot with the Ponseti method: a comparison of casting materials. J Pediatr Orthop. 2008 Mar;28(2):250-3. doi: 10.1097/BPO.0b013e318164f8e7.
- Ponseti I, Morcuende J, Mosca V, Pirani S, Dietz F, Herzenberg J, Weinstein S, Penny N, Michiel Steenbeek. Clubfoot: Ponseti Management Second Edition. Global-HELP publication
- Ponseti IV, Campos J. Observations on pathogenesis and treatment of congenital clubfoot. Clin Orthop Relat Res. 1972 May;84:50-60.
- Ponseti IV. Clubfoot management. J Pediatr Orthop. 2000 Nov-Dec;20(6):699-700.
- Ponseti IV. Common errors in the treatment of congenital clubfoot. Int Orthop. 1997;21(2):137-41. Review.
- Ponseti IV. Relapsing clubfoot: causes, prevention, and treatment. Iowa Orthop J. 2002;22:55-6.
- Ponseti IV. The ponseti technique for correction of congenital clubfoot. J Bone Joint Surg Am. 2002 Oct;84(10):1889-90; author reply 1890-1.
- Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992 Mar;74(3):448-54. Review.
- Roye DP Jr, Roye BD. Idiopathic congenital talipes equinovarus. J Am Acad Orthop Surg. 2002 Jul-Aug;10(4):239-48. Review.
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- E-20062