Actively Recruiting

Phase Not Applicable
Age: 5Years - 16Years
All Genders
NCT06912061

A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility

Led by Vestre Viken Hospital Trust · Updated on 2025-04-13

50

Participants Needed

1

Research Sites

138 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

For years, we have used a minimally invasive and biological variant of Achilles tendon lengthening using a needle inserted into the Achilles tendon so that it is weakened and can be gradually stretched to the desired length. So far, no negative effects, complications or tendon problems have been observed. A prospective study of a cohort of children and adolescents is planned where there is an indication for Achilles lengthening, such as spastic or non-spastic contracture and toe walking that results in an unwanted shortening of the Achilles tendon that makes walking difficult. We plan to include up to 50 children and adolescents over a two-year period and follow them closely for the first year after surgery. Pediatric physiotherapists will perform all clinical examinations to limit observer bias, and a radiologist will examine the tendon tissue with ultrasound before and one year after surgery to check anatomical conditions. The study will examine safety, effectiveness and feasibility of using the method, and anatomy, patient satisfaction and quality of life.

CONDITIONS

Official Title

A Needle Technique for Achilles Tendon Lengthening in Pediatric Patients: A Prospective Study on Efficacy, Safety, and Feasibility

Who Can Participate

Age: 5Years - 16Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 5 and 16 years
  • Consent given by parents or guardians
  • Indication for Achilles tendon lengthening due to toe walking or spasticity
  • Equinus foot with dorsiflexion less than or equal to 0 degrees with knee extended and heel neutral
  • Symptomatic equinus foot causing pain, discomfort, or increased fatigue
Not Eligible

You will not qualify if you...

  • Declined participation or lack of consent
  • Previous Achilles tendon lengthening surgery
  • Botulinum toxin injection in triceps surae within past 6 months
  • Contracture in ankle joint not caused by tight Achilles tendon
  • Positive Silfverskild test with dorsiflexion greater than 5 degrees with knee extended
  • Concurrent surgery or procedures on the same lower extremity, including botulinum toxin injections

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Drammen Sykehus, Vestre Viken HF

Drammen, Norway, 3004

Actively Recruiting

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Research Team

P

Per Reidar Høiness, MD Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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