Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202307804038673 Date of Approval: 14/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Achilles tenotomy versus Percutaneous Z-plasty tendon Achilles lengthening in the treatment of Idiopathic Clubfoot using Ponseti technique
Official scientific title A randomized controlled clinical trial of Achilles tenotomy versus Percutaneous Z-plasty tendon Achilles lengthening in the treatment of Idiopathic Clubfoot using Ponseti technique- a Multicenter study
Brief summary describing the background and objectives of the trial Ponseti techniques recommended the use of Achilles tenotomy to correct residual equinus before the final cast application. The success recorded with the Ponseti method of clubfoot treatment comes with reported cases of relapse during the follow-up period. The relapse rate in the long-term follow-up from the University of Iowa was 56%. However, a recent meta-analysis reported relapse rates ranging from 3.7% to 67%. (9–12) One of the major reasons for relapse in most studies was poor compliance with brace usage with higher rates recorded in those who used the brace for less than 2 years compared to those who wore theirs for up to 4 years. The earliest sign of relapse is heel varus; because percutaneous TAL can correct both equinus and varus deformity, it is thought that it could reduce relapse rates. This study aims to compare the use of Achilles tenotomy with percutaneous TAL to correct residual equinus before final cast application in patients with idiopathic clubfoot using functional outcome, percentage of relapse, and percentage of those that will require secondary procedures at three tertiary health institution in South western, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Orthopaedics,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 07/11/2023
Actual trial start date 01/04/2024
Anticipated date of last follow up 17/11/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Achilles Tenotomy 15mins The patient in this arm will undergo Achilles tenotomy as an office procedure done using aseptic technique with size 11 blade. A tiny incision is made at the medial side ( taking care to avoid injury to posterior tibial vessels) about 1 centimeter above the calcaneum. A complete trans-section of the tendon is done, and hemostasis will be secured with compression. Povidone iodine gauze dressing will be applied, the foot manipulated to 15degrees dorsiflexion and 70degrees abduction. Soft ban wraps the limb circumferentially and toe-to-groin casts will be applied; the knee flexed to 90 degrees for three weeks. The cast will be removed at three weeks and the foot fitted into Foot Abduction Brace ( FAB). This will be worn for three months continuously with one hour of free time to clean and bathe the patient, and at night for four years. Follow-up will be at three months, and every 6 months. Functional outcomes will be accessed using Ponseti/Bohr/ Sinclair score, at two years. Monitoring for relapse will be done using the presence or absence of heel varus. Any patient with relapse that requires secondary procedures such as repeat tenotomy and casting, tibialis anterior tendon transfer will be noted. 51 Active-Treatment of Control Group
Experimental Group Percutaneous Z plasty tenotomy 15mins The patient in this arm will undergo percutaneous Z plasty Achilles tenotomy as an office procedure done using aseptic technique with size 11 blade. An hemi-section of the tendon Achilles is done via stab incision in a medial and lateral direction distally and proximally at the tendon insertion and musculotendinous junction respectively. Hemostasis will be maintained with compression dressing. Povidone iodine gauze dressing will be applied, the foot manipulated to 15degrees dorsiflexion to lengthen the Achilles tendon and put in 70degrees abduction. Soft ban wraps the limb circumferentially and toe-to-groin casts will be applied; the knee flexed to 90 degrees for three weeks. The cast will be removed at three weeks and the foot fitted into Foot Abduction Brace ( FAB). This will be worn for three months continuously with one hour of free time to clean and bathe the patient, and at night for four years. Follow-up will be at three months, and every 6 months. Functional outcomes will be accessed using Ponseti/Bohr/ Sinclair score, at two years. Monitoring for relapse will be done using the presence or absence of heel varus. Any patient with relapse that requires secondary procedures such as repeat tenotomy and casting, tibialis anterior tendon transfer will be noted. 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
all consenting patient with idiopathic clubfoot who needs tenotomy using Ponseti method patients with complete Clubfoot those with syndromic clubfoot all cases of Neurogenic clubfoot e.g. Spinal dysraphism Infant: 0 Month(s)-12 Month(s) 1 Month(s) 6 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/05/2023 Health Research Ethic Committee
Ethics Committee Address
Street address City Postal code Country
Federal Medical Centre, Owo Owo 311111 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean PBS Score 2years post tenotomy
Secondary Outcome presence or absence of relapse 2years post tenotomy
Secondary Outcome proportion of those who undergo secondary procedures 2years post tenotomy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Obafemi Awolowo University Teaching Hospital Ife-Ilesa road Ile Ife Nigeria
Federal Medical Centre No 1 Adekunle Ajasin street Owo Nigeria
National Orthopaedic Hospital igbobi street Lagos Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Anthony Olasinde No1 Adekunle Street, Dept. of Orthopaedic Surgery, FMC Owo Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr. Anthony Olasinde No 1 Adekunle Ajasin Street Owo 311111 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Kehinde Oluwadiya College of Medicine, Ekiti State University, Ado Ekiti Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Anthony Olasinde olasindetony@gmail.com +2348034037893 Dept. of Orthopaedic surgery, Federal Medical Centre
City Postal code Country Position/Affiliation
Owo Nigeria Senior Lecturer Consultant Orthopaedic Surgeon
Role Name Email Phone Street address
Public Enquiries Kehinde Oluwadiya oluwadiya@gamil.com +2348035029563 Ekiti University College of Medicine
City Postal code Country Position/Affiliation
Ado Ekiti Nigeria Professor of Orthopaedic surgery
Role Name Email Phone Street address
Scientific Enquiries Lawrence Oginni lmoginni@yahoo.com +2348033379189 Obafemi Awolowo University teaching hospital,
City Postal code Country Position/Affiliation
Ile Ife Nigeria Professor OAU Ife
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes de-identified individual participant data will be shared at 2years after article publication for a period of one year on request Informed Consent Form,Statistical Analysis Plan,Study Protocol one year after article publication controlled
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information