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临床试验/CTRI/2025/01/079396
CTRI/2025/01/079396尚未招募2 期

Comparison of traditional above-knee Plaster-of-Paris casts and Plaster-of-Paris posterior slabs for immobilization of the foot and ankle during Ponseti casting for idiopathic clubfoot in infants - A randomized control trial

Dr Hitesh Shah1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
The number of casts / slabs required to obtain complete correction of the deformity (Pirani Score 0)

研究概览

简要总结

Traditionally, plaster-of-Paris has been used as the casting material for immobilising the foot and ankle  to maintain correction during Ponseti treatment of idiopathic clubfoot. (1, 2) More recently, synthetic casting material has been tried in a few centres.(5-7) Removal of the plaster-of-Paris cast involves splitting the cast with a plaster saw or soaking the cast and cutting it with scissors. The use of the noisy saw can be stressful for the baby and particles of plaster-of-Paris tend to be dispersed by the saw. Injury to the skin is also a well-recognized potential complication of the use of the plaster saw. Synthetic Soft cast, on the other hand, can be removed by unwinding the rolled cast material.

The efficacy of synthetic casts in maintaining correction of the deformity has been studied and found to be comparable to Plaster-of-Paris (5, 8) even though the mechanical properties of synthetic semi-rigid Soft cast are inferior to Plaster-of-Paris. (9) Parents preferred semi-rigid synthetic casts to Plaster-of-Paris casts. (10)

Woodcast slabs have also been used effectively in the treatment of infantile clubfoot (11). One retrospective study without a control group reported the use of a plaster slab used for immobilizing the foot and ankle during non-operative treatment of clubfoot (12).

To the best of our knowledge, no randomized control trial has been done to compare the efficacy Plaster-of-Paris casts versus Plaster-of-Paris slabs for immobilizing the foot during the treatment of infantile club foot.

References:

Ponseti IV. The ponseti technique for correction of congenital clubfoot. The Journal of bone and joint surgery American volume. 2002;84-A(10):1889-90; author reply 90-1.

  1. Bor N, Herzenberg JE, Frick SL. Ponseti management of clubfoot in older infants. Clinical orthopaedics and related research. 2006;444:224-8.

  2. Banskota B, Banskota AK, Regmi R, Rajbhandary T, Shrestha OP, Spiegel DA. The Ponseti method in the treatment of children with idiopathic clubfoot presenting between five and ten years of age. The bone & joint journal. 2013;95-B(12):1721-5.

  3. Herzenberg JE, Radler C, Bor N. Ponseti versus traditional methods of casting for idiopathic clubfoot. Journal of pediatric orthopedics. 2002;22(4):517-21.

  4. Aydin BK, Sofu H, Senaran H, Erkocak OF, Acar MA, Kirac Y. Treatment of Clubfoot With Ponseti Method Using Semirigid Synthetic Softcast. Medicine. 2015;94(47):e2072.

  5. Stephan C, Herzenberg JE, Araujo FF. Accurate determination of cast weight for neonates with clubfoot. Journal of pediatric orthopedics. 2000;20(2):230-3.

  6. Hui C, Joughin E, Nettel-Aguirre A, Goldstein S, Harder J, Kiefer G, et al. Comparison of cast materials for the treatment of congenital idiopathic clubfoot using the Ponseti method: a prospective randomized controlled trial. Canadian journal of surgery Journal canadien de chirurgie. 2014;57(4):247-53.

  7. Brewster MB, Gupta M, Pattison GT, Dunn-van der Ploeg ID. Ponseti casting: a new soft option. The Journal of bone and joint surgery British volume. 2008;90(11):1512-5.

  8. Zmurko MG, Belkoff SM, Herzenberg JE. Mechanical evaluation of a soft cast material. Orthopedics. 1997;20(8):693-8.

  9. Coss HS, Hennrikus WL. Parent satisfaction comparing two bandage materials used during serial casting in infants. Foot & ankle international. 1996;17(8):483-6.

  10. Singh KA, Shah H, Joseph B. Comparison of plaster-of-Paris casts and Woodcast splints for immobilization of the limb during serial manipulation and casting for idiopathic clubfoot in infants. Bone Joint J. 2020 Oct;102-B (10):1399-1404. doi: 10.1302/0301-620X.102B10.BJJ-2020-0181.R4. PMID: 32993325.

  11. Gigante C, Pedrotti L, Guido D. Proposal of an innovative casting technique for correction of clubfoot according to Ponseti method: a pilot study. J Pediatr Orthop B. 2019 May;28(3):242-247. doi: 10.1097/BPB.0000000000000539. PMID: 30252794.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
0.00 Year(s) 至 0.30 Year(s)(—)
性别
All

入选标准

  • Infant less than 3 months Unilateral idiopathic clubfeet Left foot of bilateral clubfeet.

排除标准

  • Clubfoot associated with arthrogryposis, spina bifida, limb deficiencies, congenital constriction band syndrome, skeletal dysplasia and syndromes.

结局指标

主要结局

The number of casts / slabs required to obtain complete correction of the deformity (Pirani Score 0)

时间窗: 1 months, 2 months, 6 months

次要结局

  • The frequency of cast or slab-related problems(i. Slippage of casts / slabs)

研究者

发起方
Dr Hitesh Shah
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Hitesh Shah

Kasturba Medical College, Manipal

研究点 (1)

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