Management of Congenital Talipes Equinovarus by Saleem's Protocol
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| ClinicalTrials.gov Identifier: NCT05957627 |
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Recruitment Status :
Recruiting
First Posted : July 24, 2023
Last Update Posted : April 2, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Congenital Talipes Equinovarus | Procedure: Saleem's protocol | Not Applicable |
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 (Clinical Trial) |
| Estimated Enrollment : | 15 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Effect of Saleem's Protocol on Foot Deformity in Congenital Talipes Equinovarus |
| Actual Study Start Date : | July 28, 2023 |
| Estimated Primary Completion Date : | August 25, 2024 |
| Estimated Study Completion Date : | September 10, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
- 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.
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| Ages Eligible for Study: | 1 Month to 1 Year (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05957627
| Contact: M Faheem Afzal, PHD | 03336966697 | faheem78601@gmail.com |
| Pakistan | |
| Pakistan Society for the Rehabilitation of Diffrently Abled Hospital | Recruiting |
| Lahore, Punjab, Pakistan, 54770 | |
| Contact: M Faheem Afzal, PHD 00923336966697 faheem78601@gmail.com | |
| Contact: Maryam Mukhtar, MS 00923030013693 psrd.crs@gmail.com | |
| Study Director: | Muhammad Saleem Bashir, FCPS | Pakistan Society for Rehabilitation of Differently Abled Hospital | |
| Principal Investigator: | Nayab Iqbal, MS | PSRD |
| Responsible Party: | Pakistan Society for Rehabilitation of Differently Abled Hospital |
| ClinicalTrials.gov Identifier: | NCT05957627 |
| Other Study ID Numbers: |
PSRD Hospital |
| First Posted: | July 24, 2023 Key Record Dates |
| Last Update Posted: | April 2, 2024 |
| Last Verified: | April 2024 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Clubfoot Talipes Equinus Deformity Foot Deformities, Acquired Foot Deformities Musculoskeletal Diseases |
Foot Deformities, Congenital Lower Extremity Deformities, Congenital Limb Deformities, Congenital Musculoskeletal Abnormalities Congenital Abnormalities |