CClinicalTrials.gg
CompletedNCT01067651Updated Feb 11, 2010

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

An interventional study of Plaster of Paris (POP) casting using the Ponseti Method and Semi-Rigid Fiberglass softcast using the Ponseti Method in Clubfoot, Ponseti Method and Talipes Equinovarus, sponsored by Alberta Children's Hospital. Completed at 1 site in Canada. Open to participants aged 1 Week to 12 Weeks. Per ClinicalTrials.gov, last updated 2010-02-11.

Sponsored by Alberta Children's Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
1 Week to 12 Weeks
Sex
All
01

Study 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 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.

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Conditions studied

  • Clubfoot
  • Ponseti Method
  • Talipes Equinovarus
  • Casting
03

In context

Clubfoot

79 studies on the registry are indexed under Clubfoot; 18 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 47 interventional studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

Alberta Children's Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Week to 12 Weeks
Sexes eligible
All

Inclusion criteria

  • congenital idiopathic clubfoot

Exclusion criteria

Exclusion Criteria:

  • positional equinovarus
  • teratologic etiologies of clubfoot
  • treatment started at another center
  • refuse randomization
  • do not understand English
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • DevicePlaster of Paris (POP) casting using the Ponseti Method
  • DeviceSemi-Rigid Fiberglass softcast using the Ponseti Method
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. need for percutaneous tendo-achilles tenotomy

  2. total time in casts (weeks)

  3. ease of cast removal

  4. time of cast removal

    Time frame: number of minutes required for each cast removal

  5. method(s) of cast removal

  6. other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.

07

Study locations

1 site
  • Alberta Children's Hospital
    Calgary, Alberta T3B 6A8, Canada
08

References and documents

Publications

  • Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64. PubMed 10934626 ↗
  • Altman 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 11304107 ↗
  • 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. doi: 10.1097/00005131-199003000-00015. PubMed 2313436 ↗
  • Carroll 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 8989690 ↗
  • 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. doi: 10.1016/s1067-2516(03)00312-0. PubMed 14566717 ↗
  • 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. doi: 10.2106/00004623-199510000-00002. PubMed 7593056 ↗
  • 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. doi: 10.1177/107110079601700809. PubMed 8863028 ↗
  • 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. doi: 10.1097/01.blo.0000065837.77325.19. PubMed 12782875 ↗
  • 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(1):22-7. doi: 10.2106/00004623-200401000-00005. PubMed 14711941 ↗
  • Flynn JM, Donohoe M, Mackenzie WG. An independent assessment of two clubfoot-classification systems. J Pediatr Orthop. 1998 May-Jun;18(3):323-7. PubMed 9600557 ↗
  • 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. doi: 10.2106/JBJS.F.00169. PubMed 17332096 ↗
  • 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. PubMed 12131451 ↗
  • 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. doi: 10.2106/00004623-200307000-00015. PubMed 12851354 ↗
  • 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. PubMed 15174556 ↗
  • Laaveg 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 ↗
  • Mihalko WM, Beaudoin AJ, Krause WR. Mechanical properties and material characteristics of orthopaedic casting material. J Orthop Trauma. 1989;3(1):57-63. doi: 10.1097/00005131-198903010-00011. PubMed 2709205 ↗
  • 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. doi: 10.1097/01.bpo.0000162015.44865.5e. PubMed 16199943 ↗
  • Noonan KJ, Richards BS. Nonsurgical management of idiopathic clubfoot. J Am Acad Orthop Surg. 2003 Nov-Dec;11(6):392-402. doi: 10.5435/00124635-200311000-00003. PubMed 14686824 ↗
  • 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. PubMed 11675543 ↗
  • 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. PubMed 18388724 ↗
  • 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. doi: 10.2106/00004623-200210000-00026. No abstract available. PubMed 12377924 ↗
  • Ponseti IV. Relapsing clubfoot: causes, prevention, and treatment. Iowa Orthop J. 2002;22:55-6. No abstract available. PubMed 12180612 ↗
  • Ponseti IV. Clubfoot management. J Pediatr Orthop. 2000 Nov-Dec;20(6):699-700. doi: 10.1097/00004694-200011000-00001. No abstract available. PubMed 11097239 ↗
  • Ponseti IV. Common errors in the treatment of congenital clubfoot. Int Orthop. 1997;21(2):137-41. doi: 10.1007/s002640050137. PubMed 9195271 ↗
  • Ponseti IV, Campos J. Observations on pathogenesis and treatment of congenital clubfoot. Clin Orthop Relat Res. 1972 May;84:50-60. doi: 10.1097/00003086-197205000-00011. No abstract available. PubMed 5032850 ↗
  • Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992 Mar;74(3):448-54. No abstract available. PubMed 1548277 ↗
  • Roye DP Jr, Roye BD. Idiopathic congenital talipes equinovarus. J Am Acad Orthop Surg. 2002 Jul-Aug;10(4):239-48. doi: 10.5435/00124635-200207000-00002. PubMed 15089073 ↗
  • Silfverskiold JP. Fiberglass versus plaster casts. How to choose between them. Postgrad Med. 1989 Oct;86(5):71-2, 74. doi: 10.1080/00325481.1989.11704430. PubMed 2636865 ↗
  • 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. doi: 10.1097/01.bpo.0000164876.97949.6b. PubMed 16199944 ↗
  • 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. doi: 10.1542/peds.113.2.376. PubMed 14754952 ↗
  • 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
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01067651
Lead sponsor
Alberta Children's Hospital
First posted
Feb 11, 2010
Last update
Feb 11, 2010

Study contacts

Jason Howard, MD
principal investigator · IWK Health Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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