Skip to content

medical versus surgical treatment in idiopathic clubfoot patients

A Comparative study between Botulinum Toxin Type A versus Tendoachillis Surgical Tenotomy in the management of Idiopathic Clubfoot by Ponseti method - BTCF

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030466
Enrollment
34
Registered
2021-01-14
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: TENDOACHILLIS SURGICAL TENOTOMY: Percutaneous needle tenotomy technique utilizes a 11 number blade to perform release of Achilles tendon without suturing and the patient may get the foo
during sleeping or resting once the child was weight bearing
and then beyond 2 years of age, a trial of no bracing o

Sponsors

AIIMS RAIPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Idiopathic clubfoot treated by Ponseti method. Age >1month and <2yrs.

Exclusion criteria

Exclusion criteria: Syndromic clubfoot Recurrent clubfoot or previously operated for clubfoot Had a previous dose of botulinum toxin. Patients not willing to give consent and follow up

Design outcomes

Primary

MeasureTime frame
1.To compare the clinical and functional outcomes of botulinum toxin type A versus tendoachillis tenotomy at the time of hindfoot stall in children with idiopathic clubfoot 2.Evaluate whether botulinum toxin type A can be effectively used for attenuating deformity correction and avoid the need for tenotomy, used as an office procedure at the time of hindfoot stall.Timepoint: baseline , 3wks , 6wks , 3months , 6 months

Secondary

MeasureTime frame
1. Ultrasonographic evaluation of Achilles tendon and gastronemius-soleus muscle in idiopathic clubfeet before and after percutaneous tenotomy and botulinum toxin injection. 2. Monitoring serial Pirani clinical clubfoot scores in infants treated by Ponseti methodTimepoint: pre tenotomy or botulinum toxin , post tenotomy or botulinum toxin at 3wks , 6 wks , 3months , 6 months

Countries

India

Contacts

Public ContactE Pandiyarajan

AIIMS , RAIPUR

dralokcagrawal@yahoo.co.in9425151634

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026