Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-01-02 @ 12:08 AM
Study NCT ID:
NCT01067651
Status:
COMPLETED
Last Update Posted:
2010-02-11
First Post:
2010-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003025', 'term': 'Clubfoot'}], 'ancestors': [{'id': 'D000070558', 'term': 'Talipes'}, {'id': 'D005531', 'term': 'Foot Deformities, Acquired'}, {'id': 'D005530', 'term': 'Foot Deformities'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D005532', 'term': 'Foot Deformities, Congenital'}, {'id': 'D038061', 'term': 'Lower Extremity Deformities, Congenital'}, {'id': 'D017880', 'term': 'Limb Deformities, Congenital'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2010-02-10', 'studyFirstSubmitDate': '2010-02-10', 'studyFirstSubmitQcDate': '2010-02-10', 'lastUpdatePostDateStruct': {'date': '2010-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of casts required to correct the clubfoot deformities', 'timeFrame': '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'}], 'secondaryOutcomes': [{'measure': 'need for percutaneous tendo-achilles tenotomy'}, {'measure': 'total time in casts (weeks)'}, {'measure': 'ease of cast removal'}, {'measure': 'time of cast removal', 'timeFrame': 'number of minutes required for each cast removal'}, {'measure': 'method(s) of cast removal'}, {'measure': 'other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Clubfoot', 'Ponseti Method', 'Talipes Equinovarus', 'Casting']}, 'referencesModule': {'references': [{'pmid': '10934626', 'type': 'BACKGROUND', 'citation': 'Dobbs MB, Morcuende JA, Gurnett CA, Ponseti IV. Treatment of idiopathic clubfoot: an historical review. Iowa Orthop J. 2000;20:59-64.'}, {'pmid': '11304107', 'type': 'BACKGROUND', 'citation': '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': '2313436', 'type': 'BACKGROUND', '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. doi: 10.1097/00005131-199003000-00015.'}, {'pmid': '8989690', 'type': 'BACKGROUND', 'citation': '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': '14566717', 'type': 'BACKGROUND', '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. doi: 10.1016/s1067-2516(03)00312-0.'}, {'pmid': '7593056', 'type': 'BACKGROUND', '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. doi: 10.2106/00004623-199510000-00002.'}, {'pmid': '8863028', 'type': 'BACKGROUND', '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. doi: 10.1177/107110079601700809.'}, {'pmid': '12782875', 'type': 'BACKGROUND', '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. doi: 10.1097/01.blo.0000065837.77325.19.'}, {'pmid': '14711941', 'type': 'BACKGROUND', '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(1):22-7. doi: 10.2106/00004623-200401000-00005.'}, {'pmid': '9600557', 'type': 'BACKGROUND', '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.'}, {'pmid': '17332096', 'type': 'BACKGROUND', '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. doi: 10.2106/JBJS.F.00169.'}, {'pmid': '12131451', 'type': 'BACKGROUND', '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.'}, {'pmid': '12851354', 'type': 'BACKGROUND', '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(7):1286-94. doi: 10.2106/00004623-200307000-00015.'}, {'pmid': '15174556', 'type': 'BACKGROUND', '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.'}, {'pmid': '7351412', 'type': 'BACKGROUND', '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.'}, {'pmid': '2709205', 'type': 'BACKGROUND', 'citation': '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': '16199943', 'type': 'BACKGROUND', '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. doi: 10.1097/01.bpo.0000162015.44865.5e.'}, {'pmid': '14686824', 'type': 'BACKGROUND', 'citation': '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': '11675543', 'type': 'BACKGROUND', '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.'}, {'pmid': '18388724', 'type': 'BACKGROUND', '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.'}, {'pmid': '12377924', 'type': 'BACKGROUND', 'citation': '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': '12180612', 'type': 'BACKGROUND', 'citation': 'Ponseti IV. Relapsing clubfoot: causes, prevention, and treatment. Iowa Orthop J. 2002;22:55-6. No abstract available.'}, {'pmid': '11097239', 'type': 'BACKGROUND', 'citation': 'Ponseti IV. Clubfoot management. J Pediatr Orthop. 2000 Nov-Dec;20(6):699-700. doi: 10.1097/00004694-200011000-00001. No abstract available.'}, {'pmid': '9195271', 'type': 'BACKGROUND', 'citation': 'Ponseti IV. Common errors in the treatment of congenital clubfoot. Int Orthop. 1997;21(2):137-41. doi: 10.1007/s002640050137.'}, {'pmid': '5032850', 'type': 'BACKGROUND', 'citation': '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': '1548277', 'type': 'BACKGROUND', 'citation': 'Ponseti IV. Treatment of congenital club foot. J Bone Joint Surg Am. 1992 Mar;74(3):448-54. No abstract available.'}, {'pmid': '15089073', 'type': 'BACKGROUND', 'citation': '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': '2636865', 'type': 'BACKGROUND', 'citation': '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': '16199944', 'type': 'BACKGROUND', '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. doi: 10.1097/01.bpo.0000164876.97949.6b.'}, {'pmid': '14754952', 'type': 'BACKGROUND', '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. doi: 10.1542/peds.113.2.376.'}, {'type': 'BACKGROUND', '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'}], 'seeAlsoLinks': [{'url': 'http://www.global-help.org', 'label': 'Website provides links to the publication entitled: Clubfoot: Ponseti Management'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '1 Week', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* congenital idiopathic clubfoot\n\nExclusion Criteria:\n\n* positional equinovarus\n* teratologic etiologies of clubfoot\n* treatment started at another center\n* refuse randomization\n* do not understand English'}, 'identificationModule': {'nctId': 'NCT01067651', 'briefTitle': 'Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method', 'organization': {'class': 'OTHER', 'fullName': "Alberta Children's Hospital"}, 'officialTitle': 'Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E-20062'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Plaster of Paris (POP)', 'interventionNames': ['Device: Plaster of Paris (POP) casting using the Ponseti Method']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'semi-rigid fiberglass softcast (SRF, 3M Scotchcast)', 'interventionNames': ['Device: Semi-Rigid Fiberglass softcast using the Ponseti Method']}], 'interventions': [{'name': 'Plaster of Paris (POP) casting using the Ponseti Method', 'type': 'DEVICE', 'armGroupLabels': ['Plaster of Paris (POP)']}, {'name': 'Semi-Rigid Fiberglass softcast using the Ponseti Method', 'type': 'DEVICE', 'armGroupLabels': ['semi-rigid fiberglass softcast (SRF, 3M Scotchcast)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3B 6A8', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': "Alberta Children's Hospital", 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Jason Howard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IWK Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Alberta Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Jason Howard', 'oldOrganization': 'IWK Health Centre'}}}}