Efficacy of Surgery for Idiopathic Toe Walking

NCT06610591 | Recruiting

• 1 other identifier: PID:17261
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

BACKGROUND: For children who walk on their tip toes, surgery is often done to lengthen their Achilles Tendon. However, there is little research to help children's surgeons choose which children with idiopathic toe walking should have surgery. METHODS: This research study will investigate how effective surgery to lengthen the Achilles Tendon is for children with idiopathic toe walking. It will explore if the children\'s quality of life, endurance, strength, range of movement or walking pattern improves after they have had surgery. This study is a pilot study with 20 participants. This means the results will be used to decide if a larger trial is needed.

Conditions

Idiopathic Toe-walking

Keywords

Children; Child; Paediatric; Pediatric; Idiopathic Toe-Walking; Surgery; Orthopaedic; Orthopedic; Pilot; FOREFOOT; Achilles Tendon

Outcome Measures

Primary Outcomes (1)

• Oxford Ankle Foot Questionnaire for Children (OxAFQ-C)

  Quality of life tool

  Pre-surgery / six months post-surgery / one year post-surgery

Secondary Outcomes (6)

• EuroQol 5 Dimensions Youth (EQ-5D-Y)

  Pre-surgery / six months post-surgery / one year post-surgery

• Single heel rise test

  Pre-surgery / one year post-surgery

• Ankle range of motion

  Pre-surgery / one year post-surgery

• Single question

  Pre-surgery / six months post-surgery / one year post-surgery

• Patient Reported Experience Measure (PREM)

  One year post-surgery

Study Arms (1)

Achilles Lengthening Surgery

Participants will receive Achilles lengthening surgery, as usual care.

Procedure: Achilles Lengthening Surgery

Interventions

Achilles Lengthening Surgery PROCEDURE

The procedure is undertaken under general anaesthetic and involves horizontal hemi-section of the Achilles tendon via small 'stab' incisions at three levels to effect a lengthening of the tendon. The patient is then placed in a walking cast for four weeks thereafter. This surgery is usual care for most children with symptomatic ITW with plantarflexion contractures who have failed non-operative management.

Achilles Lengthening Surgery

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The population relevant to this study will be children aged 8-16 years old (inclusive) with idiopathic toe walking, estimated to affect 5% of healthy children.

You may qualify if:

• Children aged 8-16 at recruitment.
• Idiopathic toe walkers based on clinicians' assessment.
• Plantarflexion contracture with knee extended of 0 degrees or less of dorsiflexion.
• Listed for surgical lengthening of the plantarflexors.

You may not qualify if:

• Unable to give informed assent or consent. Previous surgery to the lower limb.
• Unable to effectively participate in gait analysis (e.g. unable to walk 10-metres unaided, unable to walk independently, allergy to adhesive for skin markers, hyperhidrosis).
• Underlying diagnoses which may cause toe walking (e.g. muscular dystrophy, split cord malformation, cerebral palsy).
• Listed for additional procedures in the surgery for the lengthening of the plantarflexors.
• Awaiting further investigations or neurology assessment for toe walking pattern.

Sponsors & Collaborators

• University of Oxford: lead
• British Society for Children's Orthopaedic Surgery: collaborator

Study Sites (2)

St George's University Hospitals NHS Foundation Trust

Tooting, London, SW17 0QT, United Kingdom

RECRUITING

Oxford University Hospitals NHS Foundation Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Study Officials

• Alpesh Kothari, MA, BM, BCh, AFHEA, MSc, DPhil

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Yael Gelfer, BSc, MD, PhD, FRCS

  St George's University Hospitals NHS Foundation Trust

  STUDY DIRECTOR

• Julie Stebbins, DPhil SRCS CSci

  University of Oxford

  STUDY DIRECTOR

Central Study Contacts

Eileen M Morrow, BSc. MSc.

CONTACT

+441865 227 607; Eileen.Morrow@ouh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: September 9, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)