Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method

Clubfoot Clinical Trial

Official title:

Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067651
• Other study ID #: E-20062
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: February 10, 2010

Study information

• Verified date: April 2007
• Source: Alberta Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Gender: Both
• Age group: N/A to 12 Weeks

Eligibility

Inclusion Criteria:

• congenital idiopathic clubfoot

Exclusion Criteria:

• positional equinovarus

• teratologic etiologies of clubfoot

• treatment started at another center

• refuse randomization

• do not understand English

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Casting
• Clubfoot
• Equinus Deformity
• Ponseti Method
• Talipes Equinovarus

Intervention

Device:
• Plaster of Paris (POP) casting using the Ponseti Method

• Semi-Rigid Fiberglass softcast using the Ponseti Method

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Alberta Children's Hospital

Country where clinical trial is conducted

Canada, 

References & Publications (31)

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. — View Citation

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. — View Citation

Carroll NC. Clubfoot: what have we learned in the last quarter century? J Pediatr Orthop. 1997 Jan-Feb;17(1):1-2. — View Citation

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. — View Citation

Cooper DM, Dietz FR. Treatment of idiopathic clubfoot. A thirty-year follow-up note. J Bone Joint Surg Am. 1995 Oct;77(10):1477-89. — View Citation

Coss HS, Hennrikus WL. Parent satisfaction comparing two bandage materials used during serial casting in infants. Foot Ankle Int. 1996 Aug;17(8):483-6. — View Citation

Dobbs 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. — View Citation

Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64. — View Citation

Dobbs 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-A(1):22-7. — View Citation

Flynn JM, Donohoe M, Mackenzie WG. An independent assessment of two clubfoot-classification systems. J Pediatr Orthop. 1998 May-Jun;18(3):323-7. — View Citation

Haft 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. — View Citation

Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. J Pediatr Orthop. 2002 Jul-Aug;22(4):517-21. — View Citation

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-A(7):1286-94. — View Citation

Ippolito 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. — View Citation

Laaveg SJ, Ponseti IV. Long-term results of treatment of congenital club foot. J Bone Joint Surg Am. 1980 Jan;62(1):23-31. — View Citation

Mihalko WM, Beaudoin AJ, Krause WR. Mechanical properties and material characteristics of orthopaedic casting material. J Orthop Trauma. 1989;3(1):57-63. — View Citation

Morcuende JA, Abbasi D, Dolan LA, Ponseti IV. Results of an accelerated Ponseti protocol for clubfoot. J Pediatr Orthop. 2005 Sep-Oct;25(5):623-6. — View Citation

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. — View Citation

Noonan KJ, Richards BS. Nonsurgical management of idiopathic clubfoot. J Am Acad Orthop Surg. 2003 Nov-Dec;11(6):392-402. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ponseti IV. Clubfoot management. J Pediatr Orthop. 2000 Nov-Dec;20(6):699-700. — View Citation

Ponseti IV. Common errors in the treatment of congenital clubfoot. Int Orthop. 1997;21(2):137-41. Review. — View Citation

Ponseti IV. Relapsing clubfoot: causes, prevention, and treatment. Iowa Orthop J. 2002;22:55-6. — View Citation

Ponseti IV. The ponseti technique for correction of congenital clubfoot. J Bone Joint Surg Am. 2002 Oct;84-A(10):1889-90; author reply 1890-1. — View Citation

Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992 Mar;74(3):448-54. Review. — View Citation

Roye DP Jr, Roye BD. Idiopathic congenital talipes equinovarus. J Am Acad Orthop Surg. 2002 Jul-Aug;10(4):239-48. Review. — View Citation

Silfverskiold JP. Fiberglass versus plaster casts. How to choose between them. Postgrad Med. 1989 Oct;86(5):71-2, 74. — View Citation

Tindall AJ, Steinlechner CW, Lavy CB, Mannion S, Mkandawire N. Results of manipulation of idiopathic clubfoot deformity in Malawi by orthopaedic clinical officers using the Ponseti method: a realistic alternative for the developing world? J Pediatr Orthop. 2005 Sep-Oct;25(5):627-9. — View Citation

* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	need for percutaneous tendo-achilles tenotomy			No
Secondary	total time in casts (weeks)			No
Secondary	ease of cast removal			No
Secondary	time of cast removal		number of minutes required for each cast removal
Secondary	method(s) of cast removal			No
Secondary	other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.			No

External Links

•   Website provides links to the publication entitled: Clubfoot: Ponseti Management