Management of Congenital Talipes Equinovarus by Saleem's Protocol

• ClinicalTrials.gov Identifier: NCT05957627
• Recruitment Status: Recruiting
• First Posted: July 24, 2023
• Last Update Posted: April 2, 2024
• Sponsor: Pakistan Society for Rehabilitation of Differently Abled Hospital
• Information provided by (Responsible Party): Pakistan Society for Rehabilitation of Differently Abled Hospital

Tracking Information

• First Submitted Date: July 15, 2023
• First Posted Date: July 24, 2023
• Last Update Posted Date: April 2, 2024
• Actual Study Start Date: July 28, 2023
• Estimated Primary Completion Date: August 25, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 15, 2023)

PIRANI Score [ Time Frame: 6 months ]

The Pirani Score is a simple and reliable system to determine severity and monitor progress in the Assessment and Treatment of Clubfoot.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Management of Congenital Talipes Equinovarus by Saleem's Protocol
• Official Title: Effect of Saleem's Protocol on Foot Deformity in Congenital Talipes Equinovarus
• Brief Summary: 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.

Detailed Description

Congenital idiopathic clubfoot, also known as congenital talipes equinovarus, is the most common serious musculoskeletal birth defect that occurs in the United States and the world. Idiopathic clubfoot occurs in otherwise normal infants and should be distinguished from syndromic clubfoot and neurogenic clubfoot, which occur in infants as part of a syndrome or neurologic condition.Clubfoot is one of the most common congenital abnormalities affecting the lower limb, it remains a challenge not only to understand its genetic origins but also to provide effective long-term treatment. Various environmental influences have been shown to increase the risk of clubfoot in that they may affect the developing foetus in different ways including via genetic alterations, deformation, or growth arrest. The incidence has been reported to rise with increased maternal alcohol consumption], smoking, and if the mothers had undergone amniocentesis especially where a leak of amniotic fluid had occurred. In a clubfoot the soft tissues are more resistant to pressure than the bones.Untreated clubfoot causes life-long impairment, affecting individuals' ability to walk and participate in society.It can be isolated or associated with other serious congenital abnormalities, especially if bilateral and severe. The ideal aim of treatment is to achieve a functional, pain-free, plantigrade foot in the long term. Pirani scoring system is one of the classification systems and is simple, easy to use in the management of clubfoot.The Pirani scoring system works by assessing six clinical signs of contracture, which may score 0 (no deformity), 0.5 (moderate deformity) or 1(severe deformity). The total score is recorded after every visit. Pirani scoring is known to be valid and reliable for providing a good forecast about the potential treatment for an individual foot, such that a higher score at presentation may indicate the requirement of a higher number of casts to correct the deformity.

Different types of conservative methods (Ponseti techniques, Kite's method, and French physical therapy method). Six to 12 numbers of casts (mean: 10) were required in ponseti method to obtain correction of clubfoot deformities. Mean period of immobilization in a cast was 13.9 weeks (10-15 weeks). However, relapses are common in severe clubfeet and are probably caused by the same pathology that initiated the deformity. The rate of recurrence after using the Ponseti method, occurring in up to 40% of patient.Compliance with the Ponseti protocol is a major problem and has a direct effect on the success of treatment. Numerous surgeons have performed complete, plantar, lateral, medial, and posterior releases with poor results.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Congenital Talipes Equinovarus

Intervention

Procedure: Saleem's protocol

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

Study Arms

Experimental: Saleem's intervention

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.

Intervention: Procedure: Saleem's protocol

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: July 15, 2023): 15
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 10, 2024
• Estimated Primary Completion Date: August 25, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Children with congenital idiopathic clubfoot
• Both male and female under 1 year of age
• Participiants who are willing to participate

Exclusion Criteria:

• Childrens who suffer from neuropathy
• Childrens with syndromic club foot
• Childrens have done ponsetti before
• Childrens with foot drop
• Above 1 year of age

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Month to 1 Year (Child)
• Accepts Healthy Volunteers: No

Contacts

Contact: M Faheem Afzal, PHD; 03336966697; faheem78601@gmail.com

• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT05957627
• Other Study ID Numbers: PSRD Hospital
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Pakistan Society for Rehabilitation of Differently Abled Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Pakistan Society for Rehabilitation of Differently Abled Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Muhammad Saleem Bashir, FCPS; Pakistan Society for Rehabilitation of Differently Abled Hospital
• Principal Investigator: Nayab Iqbal, MS; PSRD

• PRS Account: Pakistan Society for Rehabilitation of Differently Abled Hospital
• Verification Date: April 2024