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Comparison of Surgical Blade No. 11 and Ophthalmic Knife in Idiopathic Clubfoot Patients

ConditionClubfoot
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-5
SponsorMuhammad Aamir Latif

About this trial

There is limited local data available on the comparison between surgical blade no.11 and ophthalmic knife among patients with neglected clubfoot going through tenotomy. The study has been planned with the objective of comparing the effectiveness of surgical blade no. 11 and ophthalmic knife for percutaneous Achilles tendon tenotomy in Idiopathic clubfoot patients

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Any gender

Aged 2-5 years

Diagnosed with clubfoot

Disqualifiers

Children with other neuromuscular

Chromosomal abnormalities

Arthrogryposis multiplex congenita

Myelomeningocele

Trial population

Newly diagnosed patients of clubfoot less than 6 months of age and having the Pirani score 3-6 within the study period were recruited.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Surgical Blade

    Device

    Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with surgical blade no. 11.

  • Ophthalmic Knife

    Device

    Patients after serial casting and manipulation according to the Ponseti method will go through tenotomy with ophthalmic knife.

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Group-A1 intervention
Group B: Group-B1 intervention

Trial outcomes

Primary outcomes

1

Improvement in ankle dorsiflexion

The frequency of patients will be noted who will have improved Pirani score.

Time frame
3 months

Secondary outcomes

1

Bleeding

The frequency of patients will be noted who will have bleeding severity as none, mild, moderate, or excessive.

Time frame
1 hour
2

Infection

The frequency of patients will be noted who will have infected wound.

Time frame
3 months
3

Incomplete Tenotomy

Frequency of patients who will have incomplete release or residual deformity assessed after 3

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Muhammad Aamir Latif

Lead sponsor

RESnTEC, Institute of Research

Sponsor institution

Source ClinicalTrials.gov
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