NCT05957627|UnknownDMC
Management of Congenital Talipes Equinovarus by Saleem's Protocol
Effect of Saleem's Protocol on Foot Deformity in Congenital Talipes Equinovarus
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Effect of Saleem's Protocol on Foot Deformity in Congenital Talipes Equinovarus
Sponsor study identifier
interventional
15
1 country
1
Study Start
July 28, 2023
Actual (reported)Primary Completion
August 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The main objective of this study is to evaluate the effectiveness of Saleem's protocol treatment plan for congenital ideopathic talipes equino varus deformity using early tenotomy and serial foot casting. The combined effect of early tenotomies and foot serial casting has not been proven in prior investigations. Ten kids were involved in this pilot study where Saleem's protocol approach was used. With the use of the PIRANI score, the baseline reading was evaluated. Readings were obtained before each cast performance. This study results show's early correction of foot deformity with average 4 to 5 cast and no recurrence.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 15, 2023
Actual (reported)July 24, 2023
Actual (reported)July 28, 2023
Actual (reported)August 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
PIRANI Score
The Pirani Score is a simple and reliable system to determine severity and monitor progress in the Assessment and Treatment of Clubfoot.
6 months
Early tenotomies and serial casting were used in Saleem's technique to reduce foot deforming forces. It involved 2 principal tenotmies and 2 accessory tenotmies. Principal tenotmies include tendo achillies and planter fascia release. 2 Accessory tenotmies include tibialis posterior and abductor hallucis. All tenotmies are done under local anesthesia.The foot is placed in a serial cast close to its natural anatomical position following tenotomies at first visit. children are evaluated after 1 week.This technique necessitates 4 to 5 casts on average. DB shoes were advised when the foot casting was finished, and a 6-month follow-up with the patient was conducted.
It involved 2 principal tenotmies and 2 accessory tenotmies. Principal tenotmies include tendo achillies and planter fascia release. 2 Accessory tenotmies include tibialis posterior and abductor hallucis. All tenotmies are done under local anesthesia
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Pakistan Society for the Rehabilitation of Diffrently Abled Hospital
Lahore, Punjab Province, 54770, Pakistan
Dobbs MB, Gurnett CA. Update on clubfoot: etiology and treatment. Clin Orthop Relat Res. 2009 May;467(5):1146-53. doi: 10.1007/s11999-009-0734-9. Epub 2009 Feb 18.
Engell V, Nielsen J, Damborg F, Kyvik KO, Thomsen K, Pedersen NW, Andersen M, Overgaard S. Heritability of clubfoot: a twin study. J Child Orthop. 2014 Feb;8(1):37-41. doi: 10.1007/s11832-014-0562-7. Epub 2014 Feb 7.
Cady R, Hennessey TA, Schwend RM. Diagnosis and Treatment of Idiopathic Congenital Clubfoot. Pediatrics. 2022 Feb 1;149(2):e2021055555. doi: 10.1542/peds.2021-055555.
Muhammad Saleem Bashir, FCPS
Pakistan Society for Rehabilitation of Differently Abled Hospital
Nayab Iqbal, MS
PSRD
First Submitted
July 15, 2023
First Posted
July 24, 2023
Study Start
July 28, 2023
Actual (reported)Primary Completion
August 25, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Carroll NC. Clubfoot in the twentieth century: where we were and where we may be going in the twenty-first century. J Pediatr Orthop B. 2012 Jan;21(1):1-6. doi: 10.1097/BPB.0b013e32834a99f2.
Owen RM, Capper B, Lavy C. Clubfoot treatment in 2015: a global perspective. BMJ Glob Health. 2018 Sep 3;3(4):e000852. doi: 10.1136/bmjgh-2018-000852. eCollection 2018.
Cooke SJ, Balain B, Kerin CC, Kiely NTJCO. Clubfoot. 2008;22(2):139-49
Mejabi J, Esan O, Adegbehingbe O, Orimolade E, Asuquo J, Badmus H, et al. The Pirani scoring system is effective in assessing severity and monitoring treatment of clubfeet in children. 2016;17(4):1-9.
Khan MA, Chinoy MA, Moosa R, Ahmed SK. Significance Of Pirani Score at Bracing-Implications for Recognizing A Corrected Clubfoot. Iowa Orthop J. 2017;37:151-156.
Ganesan B, Luximon A, Al-Jumaily A, Balasankar SK, Naik GR. Ponseti method in the management of clubfoot under 2 years of age: A systematic review. PLoS One. 2017 Jun 20;12(6):e0178299. doi: 10.1371/journal.pone.0178299. eCollection 2017.
Verma A, Mehtani A, Sural S, Maini L, Gautam VK, Basran SS, Arora S. Management of idiopathic clubfoot in toddlers by Ponseti's method. J Pediatr Orthop B. 2012 Jan;21(1):79-84. doi: 10.1097/BPB.0b013e328347a329.
Hu W, Ke B, Niansu X, Li S, Li C, Lai X, Huang X. Factors associated with the relapse in Ponseti treated congenital clubfoot. BMC Musculoskelet Disord. 2022 Jan 26;23(1):88. doi: 10.1186/s12891-022-05039-9.
Jowett CR, Morcuende JA, Ramachandran M. Management of congenital talipes equinovarus using the Ponseti method: a systematic review. J Bone Joint Surg Br. 2011 Sep;93(9):1160-4. doi: 10.1302/0301-620X.93B9.26947.
Ponseti IV, Zhivkov M, Davis N, Sinclair M, Dobbs MB, Morcuende JA. Treatment of the complex idiopathic clubfoot. Clin Orthop Relat Res. 2006 Oct;451:171-6. doi: 10.1097/01.blo.0000224062.39990.48.
Study Completion
September 10, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 2, 2024
Record last verified: 2024-04
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