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Management of Congenital Talipes Equinovarus by Saleem's Protocol

Primary Purpose

Congenital Talipes Equinovarus

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Saleem's protocol
Sponsored by
Pakistan Society for Rehabilitation of Differently Abled Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Talipes Equinovarus

Eligibility Criteria

1 Month - 1 Year (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pakistan Society for the Rehabilitation of Diffrently Abled HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Saleem's intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2023
Last Updated
August 23, 2023
Sponsor
Pakistan Society for Rehabilitation of Differently Abled Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05957627
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
December 18, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pakistan Society for Rehabilitation of Differently Abled Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Talipes Equinovarus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Saleem's intervention
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
Saleem's protocol
Intervention Description
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
Primary Outcome Measure Information:
Title
PIRANI Score
Description
The Pirani Score is a simple and reliable system to determine severity and monitor progress in the Assessment and Treatment of Clubfoot.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
M Faheem Afzal, PHD
Phone
03336966697
Email
faheem78601@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Saleem Bashir, FCPS
Organizational Affiliation
Pakistan Society for Rehabilitation of Differently Abled Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nayab Iqbal, MS
Organizational Affiliation
PSRD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pakistan Society for the Rehabilitation of Diffrently Abled Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54770
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M Faheem Afzal, PHD
Phone
00923336966697
Email
faheem78601@gmail.com
First Name & Middle Initial & Last Name & Degree
Maryam Mukhtar, MS
Phone
00923030013693
Email
psrd.crs@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
19224303
Citation
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Results Reference
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PubMed Identifier
24504418
Citation
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.
Results Reference
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PubMed Identifier
35104362
Citation
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.
Results Reference
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PubMed Identifier
21946867
Citation
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.
Results Reference
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PubMed Identifier
30233830
Citation
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.
Results Reference
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Citation
Cooke SJ, Balain B, Kerin CC, Kiely NTJCO. Clubfoot. 2008;22(2):139-49
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
28852350
Citation
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.
Results Reference
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PubMed Identifier
28632733
Citation
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.
Results Reference
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PubMed Identifier
21666506
Citation
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.
Results Reference
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PubMed Identifier
35081931
Citation
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.
Results Reference
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PubMed Identifier
21911524
Citation
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.
Results Reference
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PubMed Identifier
16788408
Citation
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Results Reference
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Management of Congenital Talipes Equinovarus by Saleem's Protocol

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