NCT01067651

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2010

Completed
Last Updated

February 11, 2010

Status Verified

April 1, 2007

First QC Date

February 10, 2010

Last Update Submit

February 10, 2010

Conditions

ClubfootPonseti MethodTalipes EquinovarusCasting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

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

Interventions

Plaster of Paris (POP) casting using the Ponseti MethodDEVICE
Plaster of Paris (POP)
Semi-Rigid Fiberglass softcast using the Ponseti MethodDEVICE
semi-rigid fiberglass softcast (SRF, 3M Scotchcast)

Eligibility Criteria

Age1 Week - 12 Weeks
Sexall
Age GroupsChild (0-17)

You may qualify if:

  • congenital idiopathic clubfoot

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (31)

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

    PMID: 10934626BACKGROUND

  • 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.

    PMID: 11304107BACKGROUND

  • 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.

    PMID: 2313436BACKGROUND

  • 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.

    PMID: 8989690BACKGROUND

  • 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.

    PMID: 14566717BACKGROUND

  • 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.

    PMID: 7593056BACKGROUND

  • 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.

    PMID: 8863028BACKGROUND

  • 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.

    PMID: 12782875BACKGROUND

  • 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.

    PMID: 14711941BACKGROUND

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

    PMID: 9600557BACKGROUND

  • 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.

    PMID: 17332096BACKGROUND

  • 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.

    PMID: 12131451BACKGROUND

  • 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.

    PMID: 12851354BACKGROUND

  • 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.

    PMID: 15174556BACKGROUND

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

    PMID: 7351412BACKGROUND

  • 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.

    PMID: 2709205BACKGROUND

  • 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.

    PMID: 16199943BACKGROUND

  • 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.

    PMID: 14686824BACKGROUND

  • 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.

    PMID: 11675543BACKGROUND

  • 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.

    PMID: 18388724BACKGROUND

  • 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.

    PMID: 12377924BACKGROUND

  • Ponseti IV. Relapsing clubfoot: causes, prevention, and treatment. Iowa Orthop J. 2002;22:55-6. No abstract available.

    PMID: 12180612BACKGROUND

  • Ponseti IV. Clubfoot management. J Pediatr Orthop. 2000 Nov-Dec;20(6):699-700. doi: 10.1097/00004694-200011000-00001. No abstract available.

    PMID: 11097239BACKGROUND

  • Ponseti IV. Common errors in the treatment of congenital clubfoot. Int Orthop. 1997;21(2):137-41. doi: 10.1007/s002640050137.

    PMID: 9195271BACKGROUND

  • 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.

    PMID: 5032850BACKGROUND

  • Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992 Mar;74(3):448-54. No abstract available.

    PMID: 1548277BACKGROUND

  • 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.

    PMID: 15089073BACKGROUND

  • 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.

    PMID: 2636865BACKGROUND

  • 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.

    PMID: 16199944BACKGROUND

  • 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.

    PMID: 14754952BACKGROUND

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Clubfoot

Condition Hierarchy (Ancestors)

TalipesFoot Deformities, AcquiredFoot DeformitiesMusculoskeletal DiseasesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jason Howard, MD

    IWK Health Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2010

First Posted

February 11, 2010

Last Updated

February 11, 2010

Record last verified: 2007-04

Locations

CA(1)