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COMPARISON OF TENDON RELEASE SURGERY DONE IN PATIENTS OF CLUBFOOT IN OPERATION THEATRE VERSUS DONE IN OUT PATIENT CLINIC

COMPARISON OF CLINICAL OUTCOMES, PARENTAL ANXIETY AND SURGEON SATISFACTION DURING OUTPATIENT CLINIC VERSUS OPERATING ROOM SETTING FOR ACHILLES TENOTOMY DURING PONSETI METHOD OF CLUBFOOT CORRECTION - A RANDOMISED CONTROL TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043296
Enrollment
40
Registered
2022-06-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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: ACHILLES TENOTOMY: ACHILLES TENOTOMY DONE IN OPERATION THEATRE UNDER GENERAL ANAESTHESIA IT IS A SURGICAL PROCEDURE DONE ONCE THE PATIENT IS FIT FOR TENOTOMY AS PER MODIFIED PIRANI SCOR

Sponsors

DR PREMKUMAR R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Infants (upto 12 months of age), of either gender 2.Idiopathic CTEV undergoing Ponseti method of casting 3.Parents/Guardians of patients having the ability to understand, willing to participate in the clinical investigation and subsequent follow-up.

Exclusion criteria

Exclusion criteria: 1.Non-Idiopathic CTEV like Athrogryposis, syndromic and neurogenic CTEV 2.Any Previous tenotomy/surgical intervention/soft tissue release for clubfoot correction 3.Infants unfit for undergoing surgery under general anaesthesia after Pre-Anaesthetic check-up. Being an RCT, this criterion is taken up to eliminate any bias in randomisation that might occur during allotment of groups in patients unfit for general anaesthesia.

Design outcomes

Primary

MeasureTime frame
To assess the completeness of tenotomy by means of successful correction of ankle equinus (ankle dorsiflexion 15 degrees) between the groupsTimepoint: Immediately post tenotomy, At 3weeks post tenotomy, At 3 months post tenotomy, At 6 months post tenotomy—

Secondary

MeasureTime frame
To assess periprocedural adverse effects (patient related, anaesthesia related or those associated with surgical procedure).Timepoint: 6 months follow up;To assess post-operative pain in the child using revised FLACC scaleTimepoint: Postoperative period;To assess parental anxiety through STAI questionnaireTimepoint: Pre and Postoperative period;To assess surgeon’s response through a Surgeons satisfactory questionnaireTimepoint: Postoperative period;To assess cost effectiveness of the procedure.Timepoint: During discharge;To assess relapse rate following the procedure, between the groups, during the follow up period of 6 months.Timepoint: 6 months follow up—

Countries

India

Contacts

Public ContactDR PREMKUMAR R

PGIMER

drsrk05@gmail.com9592094536

Outcome results

None listed

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